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Job Description Position Description: Position Summary: The Fill & Gel Prep Operator is responsible for preparing gel and fill materials, operating blending and mixing machinery, and ensuring accurate documentation of all batch-related activities. This role supports softgel manufacturing operations by ensuring all materials are prepared, blended, and transferred in compliance with approved Batch Manufacturing Records (BMRs), Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), and safety requirements. Essential Duties and Responsibilities:•\tOperate blending and mixing machinery independently and as part of a team to prepare gel mass and fill formulations. -\tPrepare, weigh, and verify raw materials accurately according to approved BMRs and manufacturing instructions. -\tPerform gel preparation and fill material processing including mixing, blending, heating, and transfer operations. -\tMaintain constant attention to manufacturing parameters and batch record documentation throughout production activities. -\tAccurately complete all batch manufacturing records, blending logs, and related documentation in compliance with SOPs and GDP requirements. -\tVerify labels, materials, and components against batch manufacturing records to ensure accuracy and compliance. -\tMonitor equipment and product conditions and immediately report any abnormal conditions, deviations, or safety concerns to management. -\tPerform equipment setup, cleaning, and changeover activities in accordance with SOPs and cGMP requirements. -\tHandle materials and containers safely, including lifting up to 50 lbs and pushing/pulling containers up to 500 lbs with appropriate equipment. -\tMaintain clean, organized, and inspection-ready production areas with proper status labeling of equipment and materials. -\tEnsure compliance with all safety procedures, SOPs, and cGMP guidelines to protect self and others in the workplace. -\tSupport team operations and collaborate with other departments including Quality Assurance, Encapsulation, Maintenance, and Warehouse. -\tPerform other duties as assigned by Supervisor / Manager. Educational Qualifications and Experience:•\tHigh School Diploma or equivalent required. -\t1–3 years of experience in the pharmaceutical or related manufacturing industry. -\tStrong knowledge of cGMP standards and Good Documentation Practices (GDP). -\tAbility to read, write, and speak English fluently. -\tExcellent writing, communication, and mathematical skills required. -\tExperience in blending, mixing, or softgel manufacturing processes preferred. Physical Requirements:•\tAbility to stand and walk for extended periods during the shift. -\tFrequent handling of materials, including lifting up to 50 lbs. -\tAbility to push/pull heavy containers up to 500 lbs using appropriate equipment. -\tWork in environments involving heat, mixing equipment, and manufacturing machinery. Work Environment:•\tSoftgel pharmaceutical and nutraceutical manufacturing environment. -\tExposure to blending, mixing, and heated processing equipment. -\tRequired use of Personal Protective Equipment (PPE). -\tOvertime and weekend work may be required based on production needs.

Job Description Date 11/2020 Location 1300 Airport Road, North Brunswick NJ Title Operator, Granulation/ Blending Operator 1 Department Standard Manufacturing Reports to Production, Supervisor FLSA (Exempt or Non-Exempt Non-Exempt Role Overview The Granulation/Blending Operator is responsible for the operation and set up of granulators, drying oven, blenders, screening equipment etc. in accordance with company standard operating procedures. The position includes set up, operation, cleaning, and preventative maintenance of all related equipment. The Operator is accountable for overall performance including safety, quality, shrink, attainment, and production efficiency. Operators must be capable of operating multiple like machines at one time and learning to operate a variety of equipment within the manufacturing area. Areas of Responsibility • Follow batch records, SOP’s, and cGMP's guidelines to ensure product specifications and tolerances are met., • Ensures full compliance with Company policies, procedures, GMP’s, Ethical Business Practice, and SOP’s at all times. Ensures documentation such as operation logs, batch records, etc. are fully completed, signed and in compliance with company standards and regulatory requirements., • Ensures that product meets applicable quality standards. This includes inspection for quality during operation and performing all required sampling and testing., • Complete all labeling and inventory movements to ensure accurate inventory control., • Dismantle and clean any accessories and equipment while also maintaining a clean work area., • Train in the operation, cleaning and set-up of the following pieces of equipment as well as new equipment:, • Rapid Mixer Granulator: 100L & 600L and planetary mixer, • Fluid bed dryer/processor, • Tray Drying Ovens, • Fitz mill/Multi mill, • Double cone/V- blenders: 6cu. ft. to 150 cu. ft., • Screening/ sieving equipment, • Fill in appropriate logbooks for equipment and rooms., • Perform all material handling of products and components., • Correctly document all steps on batch record., • Participate in any investigation for a deviation involving a batch record., • Maintain proper gowning and hygiene to ensure integrity of the product as per company policies., • Works extended hours and occasional weekend overtime., • Other duties as assigned Other Responsibilities Including Safety: • N/A Requirements Education & Qualification: • High school graduate or GED equivalent, • 3+ years Granulating/Blending Operator experience, • Minimum of one (1) year work experience in nutritionals, supplements, food, or pharmaceutical manufacturing industries, • 6-12 months experience, • Operates blending, screening & milling machines., • Must be proficient in proper setup and operation of blenders Certifications, Licenses, Credentials: • N/A Skills & Ability • Demonstrates ability to work in a team and assist others., • Able to follow written instructions precisely and perform basic math calculations as required., • Understands and is knowledgeable of cGMP, OSHA standards etc., • Mechanically inclined to understand inner workings of equipment., • Demonstrates the ability to read and write basic English in order to be able to understand the industry regulated instruction sheets Physical Requirements (lifting, etc.): • Ability to lift up to 50 lbs.; occasionally lift and move up to 75 pounds., • Must stand and walk on the production floor for a minimum of 6 hours per shift, • Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from the waist, or squatting, walking short distances., • Occasionally works from a rolling ladder or step stool, must be to lean over equipment as well as kneeling on the floor to clean under the equipment., • Must be able to wear all PPE including a lab coat, face mask, booties, gloves, safety glasses/goggles, and respirators. Work Environment (Office, Warehouse, temperature extremes, etc.): • Work is regularly performed inside a manufacturing environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents. 1st shift - 7:00 AM to 3:30 PM

Job DescriptionDescription: This position is located in Chantilly, Virginia (Washington DC Metro area) Relocation bonus and temporary accomodation is provided. Granules Pharmaceuticals Inc., (GPI) has worked towards strengthening our core for the past 40 years and is currently the 4th largest generic pharma company in the US for controlled substances! With our sites in Chantilly and Manassas, Virginia, we have R&D through manufacturing and packaging of our medicines including pulsatile drug release in tablet and capsule dosage form, orally disintegrating modified release tablets (XR, MR, ER), modified release suspension and controlled substances capabilities in an abuse deterrent technology platform. We are dedicated to excellence in manufacturing, quality, and commercialization of generic drugs to give customers reliable and affordable options. The Production Operator performs functions relating to the processing of drug products, ensuring product compliance to established current Good Manufacturing Practices (cGMPs), customer requirements and in conjunction with all Standard Operating Procedures (SOPs). Follows standard procedures to complete tasks, some of which may vary in scope, sequence, complexity, and timing. Applies skills and knowledge to recognize issues and to increase efficiency, throughput, and quality. Understands and runs processes to meet the assigned standards/routers and fulfills the assigned schedule; when these are not achieved, participates in the debrief to understand the reasons why and what needs to be corrected moving forward. Assists in troubleshooting process issues. Responsible for the safe and efficient execution of job duties. Hiring across all shifts: 1st, 2nd & 3rd shift 1st shift: 7:00a - 3:30p EST 2nd shift: 3:00p - 11:30p EST 3rd shift: 11:00a - 7:30a EST Must be able to train from 8:30am - 5:00pm EST for approximately 1 month Flexibility to work Overtime is Required English communication required Key Accountabilities: • Operates pharmaceutical production machinery and follows the procedures for manufacturing such as weighing, blending, dispensing, mixing, pellet coating, granulating, drying, milling, blending, compressing, Encapsulating, Coating, potent compound, etc. Meets the requirements for use of manufacturing equipment and other commonly used equipment per SOPs., • Executes written SOPs to ensure the purity of materials involved in the manufacturing process., • Properly uses all scales, including printouts, zeroing, setting tares, and daily calibration verification per SOPs., • Examines manufacturer Product ID Labels, Quality Control release tags, and Batch Production Record to verify issued/staged raw materials can be released for production., • Cleans manufacturing equipment and facilities according to established SOPs., • Executes machine changeovers from batch to batch., • May sample batches for quality testing. Executes required in-process product quality checks and documents accurately., • Understands and runs processes to meet the assigned schedule and standards/routers; when this is not achieved, participates in the debrief to understand the reasons why and what needs to be corrected moving forward. Documentation: • Completes documentation associated with manufacturing processes (e.g. batch record, protocols, and logbooks) with detail and accuracy., • Meets requirements for entries on all applicable Batch Production pages, completion and attachment of all dispensary and weight verification tickets., • Verifies the manufacturing process on BPR in an accurate and timely manner., • Provides status updates and operational challenges on status boards. Continuous Improvement: • Assists in troubleshooting process issues; refers deviations from standard procedure to the supervisor., • Typically participates in at least one continuous improvement project of a moderate scope and complexity. Safety & Compliance: • Adheres to all cGMP compliance/regulatory mandates and quality requirements., • Participates in safety teams, start-up discussions, incident debriefing sessions, etc., • Ensures compliance with SOPs, policies and procedures as required by the Company and regulatory agencies., • Maintain a clean, organized, work area. Training: • Conforms to all training requirements, including company required and machine-specific training. Teamwork & Collaboration: • Contributes to team and project success by sharing previously acquired knowledge., • Collaborates typically within own cross-functional work unit and occasionally with contacts outside own unit or department.Requirements:, • Trainee - Level I Operator:, • HS diploma, GED or College associate degree, • Minimum of 1-3 years' experience in a labor-intensive environment, • Forklift certification preferred., • Ability to communicate and comprehend English language both verbally and written, • Level II Operator (OSD/Solid Dose Manufacturing experience required):, • HS diploma, GED or College associate degree, • Minimum of 3-7 years of OSD pharmaceutical manufacturing (cGMP) experience, • Forklift certification preferred., • Level III Operator (OSD/Solid Dose Manufacturing experience required):, • HS Diploma, GED or College associate degree, • Minimum 7+ years of pharmaceutical manufacturing (cGMP) experience and certification in assigned area, as required or proficiency demonstrated in competencies as required., • Forklift certification preferred. Required Knowledge & Skills for Level II & III • Strong background in solid dose manufacturing (OSD), • Experience in 1 or more of the following areas: Compression, Granulation, Encapsulation, Wurster Coating, Coating, Fluid Bed Dryers, Bead Tower, • Capable of cleaning, setting-up, dismantling and operating state of the art tablet presses and encapsulation, i.e., Fette 3200i; Fette P 3030; MG2 planeta; Korsch XM 12., • Knowledgeable of FDA regulations, GMP, Lean Manufacturing, Six-Sigma, etc., • Solid working knowledge and skills in procedures, techniques, tools, materials and/or equipment needed for the position., • Basic math, reading, legible writing skills, and problem-solving abilities., • Proficient in sampling batches, • Ability to participate in Continuous Improvement projects. Required for all levels: Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information. Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings. Physical Requirements: Must be able to stand for long periods of time (up to 12 hour shifts), maneuver at least 50 pounds, climb ladders, wear a respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes. We believe in fair and transparent pay practices. Actual compensation is determined based on relevant experience, qualifications, skills, and internal equity.

Job Description Job Description Date 07/2019 Location 1300 Airport Road, North Brunswick NJ Title Line lead, Packaging Department Packaging Reports to Supervisor, Packaging FLSA (Exempt or Non-Exempt Exempt Role Overview The Packaging Lead is responsible for coordinating line workers’ activities to ensure their assigned packaging goals are met in compliance with all quality and safety SOPs and cGMP’s. The successful candidate will monitor, manage, and maintain equipment, operators, and processes to ensure compliance to GMP’s and safety standards. This is a working Lead role and will be required to support a station on the line. The ideal candidate will also have strong interpersonal, communication, teamwork, time management and organizational skills, will be highly motivated, self-directed, and accountable, and will have the ability to work effectively with all levels of staff across the organization. Areas of Responsibility • Coordinates with the supervisor and other Leads on an as needed basis to establish schedules, job assignments and packaging sequences to meet packaging goals., • Communicates with Supervisor to resolve employee issues and take appropriate action., • Must be available to attend training seminars/classes as needed., • Delivers and manages work assignments of packaging operators (both USPL and temporary agency)., • Coordinates break rotation schedules in a timely manner that complies with labor laws and maintains production flow., • Communicates all applicable line production information to the Supervisor in shift hand-off to ensure smooth transition., • Continually inspects raw materials and finished goods to ensure safe, quality nutritionals of the highest standard., • Continually monitors processes and finished goods to ensure all is within specification, so as to catch & resolve any error or malfunction as soon as possible and prevent waste., • Replenishs supplies, and ensure proper tools are available to operators to support efficient packaging., • Follows safety protocol to ensure that warehouse is accessible and safe for everyone., • Communicates any hazards, and/or pest sighting to appropriate department for a timely resolution., • Ensures all items on the line shadow boards are intact and accounted for., • Maintains proper gowning and hygiene to ensure integrity of the product as per cGMP’s and company policies., • Follows batch records, SOP’s, and cGMP’s guidelines to ensure product specifications and tolerances are met., • Ensures full compliance with Company policies, procedures, GMP’s, Ethical Business Practice, and SOP’s at all times., • Establishes and maintain effective relationship with employees, line leaders, supervisors, and senior managers to communicate effectively., • Provides clear direction and expectations for direct reports and assures that tasks and responsibilities are clear., • Develops employees that contribute to the daily success of the line and can be successful in the supervisor’s absence., • Identifies strengths and weaknesses of all associates on their team to ensure optimal performance; knows which employees they can assign additional tasks to, and which need closer scrutiny., • Responsible for ensuring each employee works in a safe and responsible manner in order to create an injury-free and incident-free workplace. Complies with all job-related safety and other training requirements., • Ensures all associates are trained and following all standard operating procedures., • Works extended hours and occasional weekend overtime., • Other duties as assigned. Other Responsibilities Including Safety: • N/A Requirements Education & Qualification: • High School Degree/GED and/or 2+ years Supervisory experience., • Minimum of one (1) year of work experience in nutritionals, supplements, food or pharmaceutical manufacturing industries is preferred. Certifications, Licenses, Credentials: • N/A Skills & Ability • Able to follow packaging schedules and assign personnel to the packaging lines to ensure all SOP and cGMP’s are being followed., • Must have a thorough understanding of the cause and prevention of common packaging line problems., • Must be able to follow all instructions in batch cards and sign off as required., • Demonstrates ability to work in a team and assist others., • Bi-Lingual in Spanish or Hindi is a plus., • Able to follow written instructions precisely and perform basic math calculations as required., • Understands and is knowledgeable of cGMP, OSHA standards etc., • Mechanically inclined to understand inner workings of equipment., • Able to read/write in basic English in order to understand industry regulated documents. Physical Requirements (lifting, etc.): • Able to lift up to 30 lbs.; occasionally lift and move up to 50 pounds., • Able to travel between warehouse/distribution facilities, to meet and support departments in the Company and its customers., • Able stand and walk a minimum of 6 hours per shift, • Uses hands to finger, handle or feel, or to operate or to control objects. Lifting to waist height and/or above shoulder height, frequent bending from waist, or squatting, walking short distances., • Able to occasionally work on a rolling ladder or step stool, or to lean over equipment as well as kneeling on the floor to clean under the equipment., • Able to wear all PPE including lab coat, face mask, booties, gloves, safety glasses/goggles and respirator. Work Environment (Office, Warehouse, temperature extremes, etc.): • Work is regularly performed inside a manufacturing environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship. USPL is proud to be an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law. Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment. 1st shift - 7.00 am to 3:30 pm

Job Description Job Description Date 11/2020 Location 1300 Airport Road, North Brunswick NJ Title Production Operator Department Standard Manufacturing - Beads Reports to Production Supervisor FLSA (Exempt or Non-Exempt Non-Exempt Role Overview The Beads Operator is responsible for the operation and set up of mills, granulators, drying oven, blenders, screening equipment, fluid bed dryers, feeders, etc. in accordance with company standard operating procedures. The position includes set up, operation, cleaning, and preventative maintenance of all related equipment. The Operator is accountable for overall performance including safety, quality, shrink, attainment, and production efficiency. Operators must be capable of operating multiple like machines at one time and learning to operate a variety of equipment within the manufacturing area. Areas of Responsibility • Follows batch records, SOP’s, and cGMP's guidelines to ensure product specifications and tolerances are met., • Ensures full compliance with Company policies, procedures, GMP’s, Ethical Business Practice, and SOP’s at all times. Ensures documentation such as operation logs, batch records, etc. are fully completed, signed and in compliance with company standards and regulatory requirements., • Ensures that product meets applicable quality standards. This includes inspection for quality during operation and performing all required sampling and testing., • Completes all labeling and inventory movements to ensure accurate inventory control., • Dismantles and cleans any accessories and equipment while also maintaining a clean work area., • Trains in the operation, cleaning and set-up of the following pieces of equipment as well as new equipment:, • Vector Fluid Bed Dryer, inserts, and ancillary equipment, • K-Tron powder feeder, • Air Classifying Mill, • Fitz mill/Multi mill, • Double cone/V- blenders: 6cu. ft. to 150 cu. ft., • Screens/ sieves equipment, • Fills in appropriate logbooks for equipment and rooms., • Performs all material handling of products and components., • Correctly document all steps on batch record., • Participates in any investigation for a deviation involving a batch record., • Maintains proper gowning and hygiene to ensure integrity of the product as per company policies., • Works extended hours and occasional weekend overtime., • Other duties as assigned Other Responsibilities Including Safety: • Works in a safe and responsible manner to create an injury-free and incident-free workplace., • Complies with all job-related safety and other training requirements., • Keeps management informed of area activities and of any significant problems. Requirements Education & Qualification: • High school graduate or GED equivalent, • Minimum of one (1) year work experience in nutritionals, supplements, food, or pharmaceutical manufacturing industries. Certifications, Licenses, Credentials: • N/A Skills & Ability • Demonstrates ability to work in a team and assist others., • Able to follow written instructions precisely and perform basic math calculations as required., • Understands and is knowledgeable of cGMP, OSHA standards, etc., • Mechanically inclined to understand the inner workings of the equipment., • Demonstrates the ability to read and write basic English to be able to understand the industry-regulated instruction sheets. Additional Skills and Required Technical Ability per Position Level: Level 1 Pay Rate: $19.00 - $23.00 • 1-2 years experience, • Operates fluid bed dryer, blending, screening & milling machines., • Must be proficient in proper setup and operation of equipment in work area Level 2 Pay Rate: $22.00 - $24.00 • 2-4 years’ experience plus responsibilities above, • Operates, cleans, sets all machines in work area., • A clear understanding of the principal functions of the bead department., • Completes batch card independently, follow SOP’s and GMP’s strictly, • Certified forklift operator. Level 3 Pay Rate: $24.00 - $27.00 • 5+ Years’ experience plus responsibilities above, • Operates, cleans, sets all machines in work area., • Must be highly skilled in the proper set up an operation of blenders and granulators., • Applies cGMP’s & completes batch card instructions accurately - able to train all activities in bead manufacturing department., • Ability to work with minimum to no supervision, • Ability to train new employees Physical Requirements (lifting, etc.): • Ability to lift up to 50 lbs.; occasionally lift and move up to 75 pounds., • Must stand and walk on the production floor for a minimum of 6 hours per shift, • Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from the waist, or squatting, walking short distances., • Occasionally works from a rolling ladder or step stool, must be to lean over equipment as well as kneeling on the floor to clean under the equipment., • Must be able to wear all PPE including a lab coat, face mask, booties, gloves, safety glasses/goggles, and respirators. Work Environment (Office, Warehouse, temperature extremes, etc.): • Work is regularly performed inside a manufacturing environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship. USPL is proud to be an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law. Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment. 2nd shift - 3:00 PM to 11:30 PM

Job Description Position Description: Position Summary The Encapsulation Operator is responsible for the setup, operation, cleaning, and monitoring of encapsulation machines in compliance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), and company safety policies. This role ensures accurate and efficient production while maintaining product quality, proper documentation, and equipment performance in a pharmaceutical or nutraceutical manufacturing environment. Key Responsibilities -\tOperate, set up, clean, and assemble encapsulation machines according to SOPs and cGMP requirements. -\tMonitor machine operation and make adjustments to maintain product quality and production efficiency. -\tPerform equipment checks before, during, and after production runs. -\tComplete batch records, logbooks, and production documentation accurately and in a timely manner. -\tFollow all cGMP, SOP, safety, and gowning requirements during manufacturing operations. -\tInspect capsules for quality attributes including appearance, weight variation, defects, and fill consistency. -\tAssist in troubleshooting machine issues and report mechanical concerns to maintenance or supervisors. -\tSupport machine changeovers, line clearance activities, and cleaning verification processes. -\tMaintain cleanliness and organization of equipment and manufacturing areas. -\tEnsure proper handling and identification of materials, components, and finished products. -\tAssist with inventory reconciliation and material accountability during production activities. -\tWork collaboratively with Quality Assurance, Maintenance, Warehouse, and Production teams. -\tSupport audit readiness and regulatory compliance activities. -\tCross-train and provide operational support in other manufacturing areas as needed. -\tPerform additional duties as assigned by the Encapsulation Lead, Supervisor, or Production Manager. Educational Qualification & Experience -\tHigh school diploma or equivalent required. -\tMinimum 1–3 years of manufacturing experience in pharmaceutical, nutraceutical, food, or related industry preferred. -\tKnowledge of cGMP and SOP compliance preferred. -\tBasic mechanical aptitude and ability to operate manufacturing equipment. -\tAbility to read, write, and communicate effectively in English. -\tGood mathematical, organizational, and documentation skills. Physical Requirements -\tAbility to stand for 8-10 hours during shifts. -\tAbility to lift up to 50 lbs occasionally. -\tAbility to bend, reach, push, pull, and perform repetitive tasks as required. Work Environment & Safety -\tConstant exposure to noise levels loud enough to require hearing protection. -\tExposure to warm temperature conditions, machine vibration, fumes, and oily/wet environments is sufficient to cause minor discomfort. -\tEmployees are required to wear appropriate Personal Protective Equipment (PPE), including protective eyewear, hair nets, uniforms, safety shoes, gloves, and hearing protection as required. -\tThe incumbent must be able to perform this job safely in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), and company safety policies without endangering the health or safety of self or others.

Job Description Job Description Date 06/2025 Location 1300 Airport Road, North Brunswick NJ Title Operator, Granulation/ Blending Department Standard Manufacturing Reports to Production, Supervisor FLSA (Exempt or Non-Exempt Non-Exempt Role Overview The Granulation/Blending Operator is responsible for the operation and set up of granulators, drying oven, blenders, screening equipment etc. in accordance with company standard operating procedures. The position includes set up, operation, cleaning, and preventative maintenance of all related equipment. The Operator is accountable for overall performance including safety, quality, shrink, attainment, and production efficiency. Operators must be capable of operating multiple like machines at one time and learning to operate a variety of equipment within the manufacturing area. Areas of Responsibility • Follow batch records, SOP’s, and cGMP's guidelines to ensure product specifications and tolerances are met., • Ensures full compliance with Company policies, procedures, GMP’s, Ethical Business Practice, and SOP’s at all times. Ensures documentation such as operation logs, batch records, etc. are fully completed, signed and in compliance with company standards and regulatory requirements., • Ensures that product meets applicable quality standards. This includes inspection for quality during operation and performing all required sampling and testing., • Complete all labeling and inventory movements to ensure accurate inventory control., • Dismantle and clean any accessories and equipment while also maintaining a clean work area., • Train in the operation, cleaning and set-up of the following pieces of equipment as well as new equipment:, • Rapid Mixer Granulator: 100L & 600L and planetary mixer, • Fluid bed dryer/processor, • Tray Drying Ovens, • Fitz mill/Multi mill, • Double cone/V- blenders: 6cu. ft. to 150 cu. ft., • Screening/ sieving equipment, • Fill in appropriate logbooks for equipment and rooms., • Perform all material handling of products and components., • Correctly document all steps on batch record., • Participate in any investigation for a deviation involving a batch record., • Maintain proper gowning and hygiene to ensure integrity of the product as per company policies., • Works extended hours and occasional weekend overtime., • Other duties as assigned. Other Responsibilities Including Safety: • N/A Requirements Education & Qualification: Level 1 Pay Rate $19.00 - $22.00 • High school graduate or GED equivalent, • 3+ years Granulating/Blending Operator experience, • Minimum of one (1) year work experience in nutritionals, supplements, food, or pharmaceutical manufacturing industries, • 6-12 months experience, • Operates blending, screening & milling machines., • Must be proficient in proper setup and operation of blenders. Level 2 Pay Rate $21.00 - $24.00 • High school graduate or GED equivalent, • 3+ years Granulating/Blending Operator experience, • Minimum of one (1) year work experience in nutritionals, supplements, food, or pharmaceutical manufacturing industries, • 1 years of experience, • Operates 5 machines (blending, milling, sifting, tray dryer and granulation)., • A clear understanding of the principal functions of the blending /granulation department. Certified forklift operator., • Completes batch card independently, follow SOP’s and GMP’s strictly Level 3 Pay Rate $23.00 - $31.00 • High school graduate or GED equivalent, • 3+ years of experience, • Operate all machines., • Must be highly skilled in the proper set up an operation of blenders and granulators., • Applies cGMP’s & completes batch card instructions accurately - able to train all activities in blending & granulation department. Certifications, Licenses, Credentials: • N/A Skills & Ability • Demonstrates ability to work in a team and assist others., • Able to follow written instructions precisely and perform basic math calculations as required., • Understands and is knowledgeable of cGMP, OSHA standards etc., • Mechanically inclined to understand the inner workings of equipment., • Demonstrates the ability to read and write basic English in order to be able to understand the industry regulated instruction sheets. Physical Requirements (lifting, etc.): • Ability to lift up to 50 lbs.; occasionally lift and move up to 75 pounds., • Must stand and walk on the production floor for a minimum of 6 hours per shift., • Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from the waist, or squatting, walking short distances., • Occasionally works from a rolling ladder or step stool, must be to lean over equipment as well as kneeling on the floor to clean under the equipment., • Must be able to wear all PPE including a lab coat, face mask, booties, gloves, safety glasses/goggles, and respirators. Work Environment (Office, Warehouse, temperature extremes, etc.): • Work is regularly performed inside a manufacturing environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship. USPL is proud to be an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law. Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired emplo

Job Description Job Description Date 10/2025 Location 22 Van Dyke Avenue, New Brunswick NJ 08901 / 1300 Airport Road, North Brunswick NJ 08902 Title Operator, Dispensing Department Dispensing Reports to Manager, Dispensing FLSA (Exempt or Non-Exempt) Non-Exempt Role Overview The Dispensing Operator will perform all functions related to dispensing of material, receipt of goods, put-away material into warehouse aisles, pull out material per Batch card/Pick ticket, put back to same location from where it was pulled for batches, manual order processing, order auditing, shipment preparation, pallet building, transferring material from wood to plastic pallets, and cycle counting inventory. All functions may require the use of powered industrial trucks, Syspro or RF as needed. Will need to work in temperature-controlled areas. Areas of Responsibility Level 1: Dispensing Operator Overview: This is a training-level role for individuals with limited or no prior experience in pharmaceutical dispensing. Works under close supervision while learning company SOPs, GMP standards, and equipment operations. Key Responsibilities: • Assist in pulling and weighing raw materials under supervision., • Learn to read and interpret batch cards and pick slips., • Calibrate scales before use., • Cleans room after batch is complete, • Ensures safety and quality standards are consistently followed., • Maintain basic cleanliness of work area and equipment., • Support warehouse duties such as material receipt and basic inventory handling., • Follow safety procedures and learn PPE protocols., • Operate pallet jacks or assist with forklift activities (if certified). Level 2: Dispensing Operator Overview: This level is for operators with hands-on experience in pharmaceutical or supplement dispensing. Operators are responsible for completing batch-related activities with minimal supervision and maintaining documentation compliance. Key Responsibilities: • Dispense raw materials independently per batch cards., • Reviews batch card. Determine material to be used in the batch. Pull out material per requirement and enter in logbooks., • Performs requests received from other departments such as R&D, Production, QA or Purchasing etc., • Cleans room after batch is complete, • Ensures safety and quality standards are consistently followed., • Weigh materials accurately and calibrate scales before use., • Use Syspro or RF systems for inventory control., • Handle, put-away, return, and transfer of goods between warehouse locations., • Perform manual order processing, auditing, and preparation for shipments., • Maintain gowning and hygiene protocols in controlled environments., • Ensure accurate documentation in logs and batch records. Level 3: Dispensing Operator Overview: A highly experienced operator who may act as a team lead or trainer. Oversees batch dispensing activities, ensures compliance, and supports continuous improvement initiatives. Key Responsibilities: • Lead batch dispensing operations; verify materials and documentation., • Train and mentor entry and intermediate-level operators., • Collaborate with cross-functional teams (QA, R&D, Production)., • Reviews batch card. Determine material to be used in the batch. Pull out material per requirement and enter in logbooks., • Performs requests received from other departments such as R&D, Production, QA or Purchasing etc., • Cleans room after batch is complete, • Ensures safety and quality standards are consistently followed., • Conduct cycle counts and helps manage inventory accuracy., • Troubleshoot equipment or material issues; escalate when necessary., • Lead compliance audits for dispensing areas., • Support continuous improvement, safety, and 5S initiatives. Physical & Environmental Requirements (All Levels): • Able to lift 55 lbs regularly; occasionally up to 75 lbs., • Stand/walk for 6+ hours per shift., • Work in temperature-controlled rooms with PPE (lab coat, gloves, face mask, respirator, etc.)., • Exposure to dust, noise, and cleaning agents. Bottom of Form Requirements Education & Qualification: Level 1: Dispensing Operator • High school diploma or GED., • 0–1 year of experience in manufacturing or warehouse setting., • Basic math and English reading skills., • Willingness to learn cGMP, OSHA, and SOPs. Level 2: Dispensing Operator • High school diploma or GED., • 2+ years of experience in a pharmaceutical production environment., • Forklift operation experience (certification preferred)., • Familiarity with cGMP and SOP documentation standards., • Attention to detail and ability to troubleshoot basic dispensing issues. Level 3: Dispensing Operator Requirements: • High school diploma or GED; technical certification a plus., • 4+ years of dispensing experience in a GMP-regulated and within a pharmaceutical production environment, • Strong understanding of regulatory compliance (FDA, GMP, OSHA)., • Proven ability to lead teams and communicate effectively., • Proficient in inventory software (Syspro or similar ERP systems)., • Additional experience in granulation, compression, or blending is a strong plus. Certifications, Licenses, Credentials: • Prior certification to operate a sit-down forklift is a plus. Skills & Ability • Demonstrates ability to work in a team and assist others., • Able to follow written instructions precisely and perform basic math calculations as required., • Understands and is knowledgeable of cGMP, OSHA standards, etc., • Mechanically inclined to understand the inner workings of the equipment., • Demonstrates the ability to read and write basic English to be able to understand the industry-regulated instruction sheets., • Must have attention to detail. Physical Requirements (lifting, etc.): • Ability to lift up to 55 lbs.; occasionally lift and move up to 75 pounds., • Must stand and walk on the production floor for a minimum of 6 hours per shift, • Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from the waist, or squatting, walking short distances., • Occasionally works from a rolling ladder or step stool, must be to lean over equipment as well as kneeling on the floor to clean under the equipment., • Must be able to wear all PPE including a lab coat, face mask, booties, gloves, safety glasses/goggles, and respirators. Work Environment (Office, Warehouse, temperature extremes, etc.): • Work is regularly performed inside a manufacturing environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship. USPL is proud to be an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law. Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment 2nd shift: 3:00 PM - 11:15 PM

Job Description Position Description: SUMMARY: The Encapsulation Lead Operator is responsible for overseeing the setup, operation, and performance of encapsulation machines while ensuring compliance with Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP). This role leads and trains machine operators, ensures production efficiency, maintains product quality, and supports troubleshooting and minor mechanical adjustments. The Lead Operator plays a critical role in maintaining safety, quality, and productivity across the encapsulation production line. Key Responsibilities:•\tOversee setup, operation, and cleaning of encapsulation machines in compliance with SOPs and cGMP. -\tMonitor and adjust equipment to maintain product quality and production efficiency and operate and support multiple machines simultaneously. -\tLead, train, and coach machine operators; ensure ongoing skill development. -\tMaintain and track employee training records; conduct periodic evaluations. -\tComplete and review batch records, logbooks, and production documentation accurately. -\tMaintain proper documentation practices to support audits and inspections. -\tEnsure all activities comply with cGMP, SOPs, and regulatory requirements. -\tPerform basic troubleshooting and assist with minor mechanical maintenance. -\tEnsure adherence to safety procedures, gowning requirements, and cleanroom standards. -\tMonitor machine performance and operator productivity; identify areas for improvement. -\tProvide cross-training and operational support across manufacturing areas as needed. -\tCoordinate equipment assembly/disassembly and ensure proper machine setup. -\tMaintain compliance with regulatory requirements and support audit readiness. -\tProvide operational support in other manufacturing areas as needed. -\tPerform additional duties as assigned by the Encapsulation Supervisor OR Production Manager. Educational Qualification & Experience:•\tHigh school diploma or equivalent required. -\tMinimum 3–5 years of experience in pharmaceutical or related manufacturing industry. -\tStrong knowledge of cGMP and SOP compliance. -\tAbility to read, write, and communicate effectively in English. -\tStrong mathematical and documentation skills. -\tMechanical aptitude with hands-on experience in encapsulation or similar equipment.

Job Description Position Description: Position Summary:Assist the Lead Operator in the setup, operation, and monitoring of assigned bottling lines. Perform packaging and bottling activities in compliance with cGMP regulations, SOPs, safety requirements, and quality standards. Assume Lead Operator responsibilities in the absence of the Lead Operator.Essential Duties and Responsibilities: Assist in the overall performance and operation of the assigned bottling line. Assist the Lead Operator with equipment setup, operation, changeovers, and line start-up activities. Perform tasks as assigned by the Lead Operator, Bottling Supervisor, or Production Management. Assume Lead Operator duties in the absence of the Lead Operator. Complete all required documentation, including batch records, production logs, and equipment records accurately and in a timely manner. Perform line clearance activities and cleaning procedures before, during, and after production runs. Assist during setup processes by performing cleanup and line clearance procedures. Operate bottling, capping, labeling, coding, induction sealing, and packaging equipment. Monitor product quality and packaging integrity throughout production runs. Ensure all SOPs, cGMP requirements, and safety procedures are followed at all times. Perform basic troubleshooting, adjustments, and setup of bottle packaging equipment. Report equipment malfunctions, product defects, or process deviations to supervision immediately. Assist with preventive maintenance activities as required. Verify packaging materials, labels, and components prior to use. Maintain a clean, organized, and safe work environment. Assist the Bottling Supervisor in promoting a positive, team-oriented culture focused on safety, quality, and productivity. Support continuous improvement initiatives and participate in training programs as required.Educational Qualifications and Experience:High School Diploma or equivalent required.Previous 2–3 years of experience in a pharmaceutical, nutraceutical, food, beverage, or related manufacturing environment.Knowledge of cGMP regulations and pharmaceutical manufacturing practices.Ability to read, write, and speak English fluently.Strong written communication and basic mathematical skills.Basic mechanical aptitude and troubleshooting skills.Physical & Work Requirements:Ability to stand and walk for extended periods.Ability to lift and move up to 50 pounds.Frequent bending, reaching, pushing, pulling, and repetitive motion.Ability to work in a fast-paced manufacturing environment. \Overtime and weekend work may be required based on production schedules.Required use of Personal Protective Equipment (PPE).

Job Description Job Description Date 05/2018 Location 1300 Airport Road, North Brunswick NJ Title Operator, Packaging Department Packaging Reports to Supervisor, Packaging FLSA (Exempt or Non-Exempt Non-Exempt Role Overview The Packaging Operator is responsible for safely operating the packaging equipment to package in process products in accordance with company standard operating procedures and the packaging order. The position includes set up, operation, cleaning, and preventative maintenance of all related equipment. Operators must be capable of operating multiple like machines at one time and learning to operate a variety of equipment within the packaging work rooms. Areas of Responsibility • Follow batch records, SOP’s, and cGMP's guidelines to ensure product specifications and tolerances are met., • Ensures full compliance with Company policies, procedures, GMP’s, Ethical Business Practice, and SOP’s at all times. Ensures documentation such as operation logs, batch records, etc. are fully completed, signed and in compliance with company standards and regulatory requirements., • Ensures that product meets applicable quality standards. This includes inspection for quality during operation and performing all required sampling and testing., • Handle start up and shut down duties pertaining to equipment at the beginning and end of each shift., • Load and unload items into packaging machine and remove rejected packages to be isolated as rejects or re-inspection., • Execute packaging processes in accordance with packaging record/work orders., • Troubleshoot and make appropriate adjustments to machine to maintain packaging specifications., • Responsible for disposal of rejected tablets and packaging components in the designated area., • Responsible to clear any jams that do not require a mechanic, • Dismantle and clean any accessories and equipment while also maintaining a clean work area., • Fill in appropriate logbooks for equipment and rooms., • Perform all material handling of products and components., • Correctly document all steps on batch record., • Maintain proper gowning and hygiene to ensure integrity of the product as per company policies., • Works extended hours and occasional weekend overtime., • Other duties as assigned. Other Responsibilities Including Safety: • N/A Requirements Education & Qualification: • High school graduate or GED equivalent and/or 1+ years in bottle, blister, and other assorted tablet packaging, • Minimum of one (1) year work experience in nutritionals, supplements, food, or pharmaceutical manufacturing industries Certifications, Licenses, Credentials: • N/A Skills & Ability • Demonstrates ability to work in a team and assist others., • Able to follow written instructions precisely and perform basic math calculations as required., • Understands and is knowledgeable of cGMP, OSHA standards etc., • Mechanically inclined to understand inner workings of equipment., • Demonstrates the ability to read and write basic English in order to be able to understand the industry regulated instruction sheets. Physical Requirements (lifting, etc.): • Ability to lift up to 35 lbs.; occasionally lift and move up to 50 pounds., • Must stand and walk on production floor a minimum of 8 hours per shift, • Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from waist, or squatting, walking short distances., • Occasionally works from a rolling ladder or step stool, must be able to lean over equipment as well as kneeling on the floor to clean under the equipment., • Must be able wear all PPE including safety shoes, lab coat, face mask, booties, gloves, safety glasses/goggles and respirators. Work Environment (Office, Warehouse, temperature extremes, etc.): • Work is regularly performed inside a manufacturing environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employee can be exposed daily to chemicals and cleaning agents. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship. USPL is proud to be an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law. Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment. shift schedule 2nd shift - 3:15 PM to 11:45 PM Job Description Acknowledgement I have read and understand the job requirements, responsibilities, and expectations set forth in the job description provided for my position. I attest that I can perform the essential job functions as outlined with or without any reasonable accommodations. This Job Description has been reviewed with my supervisor. 2nd shift 3:15 PM to 11:45PM

Job Description The Human Resources Manager will oversee a small team and focus on operational HR functions that support employee relations, performance management, and workforce planning. This position plays a key role in administering benefits, developing HR policies, resolving conflicts, and ensuring compliance using Paychex Flex. The role emphasizes hands-on management without travel requirements, contributing to a positive and productive workplace. Responsibilities • Manage recruitment and onboarding processes, • Maintain effective employee relations and resolve conflicts, • Oversee performance management and employee engagement initiatives, • Ensure compliance with labor laws and company policies, • Develop and update HR policies and procedures, • Administer employee benefits and payroll systems using Paychex Flex, • Prepare HR reports and support workforce planning, • Coordinate training and development programs Preferred Qualifications • 5+ years of experience in human resources management, • Strong expertise in employee relations and conflict resolution, • Proficiency with HRIS systems, especially Paychex Flex, • Knowledge of labor law compliance, • Excellent communication and organizational skills\nCompany Description We are a leading manufacturer of store-brand and branded pharmaceutical products, partnering with major retail chains and national brands across the country. Our commitment to quality, safety, and regulatory compliance sets us apart in the pharmaceutical industry. We are a leading manufacturer of store-brand and branded pharmaceutical products, partnering with major retail chains and national brands across the country. Our commitment to quality, safety, and regulatory compliance sets us apart in the pharmaceutical industry.

Job Description Date 05/2018 Location 1300 Airport Road, North Brunswick NJ Title Supervisor, Packaging Department Packaging Reports to Manager, Packaging FLSA (Exempt or Non-Exempt Exempt Role Overview The Packaging Supervisor position is responsible to assist with planning, coordinating, and managing all activities of those employees in the packaging department. This person will demonstrate a high level of creativity and independence in the design and development of new or improved packaging processes, systems, prototypes, and projects from concept to production. Safety, sanitation, housekeeping, GMP standards, problem solving ability as well as good employee relations are considered key elements to success. They will need to coordinate and partner with other departments to maintain schedules and effect necessary changes and revisions. Areas of Responsibility • Ensures that timelines are met by distributing workload in accordance with changing priorities., • Ensures operation of equipment by coordinating, preventative maintenance, repairs; and evaluating new equipment and techniques., • Responsible for packaging production employees including mechanical support staff., • Oversees day to day operation of filling and packaging environment., • Coordinate activities and assist in setting priorities of mechanics and warehouse materials handlers to keep the production lines running efficiently and consistently., • Communicate all packaging activities with the Lead QA inspector to proper QA support is available., • Create and issue required packaging paperwork to line leaders and audit it daily for completeness and accuracy., • Prepare for the new shift by reviewing all entries to the log, packaging line status and issues., • Conduct routine meetings with departmental employee groups to provide guidance and to review problems, new procedures, and customer issues., • Works closely with Quality and Planning department to execute production plan., • Evaluates/solves production problems by reviewing the area of concern, developing potential solutions, technically evaluating, or testing the solutions, and preparing recommendations for management., • Maintain a work environment which fosters teamwork and supports the company’s efforts to continuously improve processes., • Prepares production reports and variance explanations, and accurately complies and files, Inventories, and order production supplies. Quality • Participate in any investigation for a deviation involving a batch record., • Maintain proper gowning and hygiene to ensure integrity of the product as per cGMP’s and company policies., • Follow batch records, SOP’s, and cGMP guidelines to ensure product specifications and tolerances are met., • Ensures full compliance with Company policies, procedures, GMP’s, Ethical Business Practice, and SOPs at all times., • Ensures documentation such as operation logs, batch records, etc. are fully completed, signed and in compliance with company standards and regulatory requirements., • Complete necessary Activity Reports for management., • Monitor the flow of paperwork from Receiving to Inventory Control Specialist for timely data entry., • Resolve discrepancies with shipping, invoices, packing slips, and receiver reports., • Ensure products are staged for counting and inspection., • Ensure products are stored properly to conserve space and comply with safety procedures. People • Foster a collaborative environment in which diverse backgrounds are respected and valued., • Establish and maintain effective relationship with your peers, team, and senior managers in order to communicate effectively., • Provides clear direction & expectations for direct reports and assures that tasks & responsibilities are clear., • Sets goals and objectives in alignment with the organization for self and direct reports: Creates action plans, sets milestones, and delivers progress reports and developmental plans for team members., • Develop employees that contribute to the daily success of the line and can be successful in the supervisor’s absence., • Maintains open lines of communication with employees, peers, and management., • Assumes responsibility for the efficient, timely, and accurate completion of warehouse functions, • Learns and understands specific manufacturing operations sufficiently and can provide support in other areas as needed., • Evaluates performance of employees and creating corrective action plans where appropriate., • Assists with personnel decisions including hiring, terminations, attendance management, wage decisions, transfers, and promotions., • Interpret and explain the policies of the USPL Handbook so employees can understand the application of each policy as well as management’s purpose for each policy., • Apply all company policies fairly and consistently across departments and develop a relationship of trust and transparency with their employees., • Identify strengths and weaknesses of all associates on their team to ensure optimal performance; knows which employees they can assign additional tasks to, and which need closer scrutiny. Mechanical • Perform moderate to complex adjustments, maintenance, and repairs to packaging equipment., • Perform changeover and set-up of packaging machines as well as troubleshoot mechanical and basic electrical systems and make appropriate repairs to machines., • Perform daily preventative maintenance on plant equipment such as packaging equipment, conveyors, and compressors., • Assist on equipment installations within the plant structure. Complete work orders to repair machinery., • Read and interpret equipment manuals to perform required maintenance and service., • Diagnose problems, replace, or repair parts, test and make adjustments., • Use a variety of hand and power tools, electric meters, and material handling equipment in performing duties., • Set up full line configurations of multiple pieces of equipment, independently., • Interact with management to assist in new project quotation generation by providing input on equipment choices, potential capital purchases or improvements and estimated output., • Detect faulty operations, defective material, and report those and any unusual situations to proper supervision. Other Responsibilities Including Safety: • Responsible for ensuring each employee works in a safe and responsible manner in order to create an injury-free and incident-free workplace. Complies with all job-related safety and other training requirements., • Keeps management informed of area activities and of any significant problems., • Responsible for maintenance of warehouse equipment, providing both preventive maintenance programs and communicating all necessary repairs to Director of Facilities., • Responsible for warehouse safety programs to provide a safe and clean workplace for employees and within the regulations of all OSHA local and state regulations., • Ensure all associates are trained and following all standard operating procedures., • Works extended hours and occasional weekend overtime., • Other duties as assigned. Requirements Education & Qualification: • BA degree and/or 4+ years Supervisory experience, • Minimum of two (2) years of work experience in nutritional’s, supplements, food, or pharmaceutical manufacturing industries is preferred., • Hands on experience with any of the following processes: Blending/Granulation, Tablet Compression and/or Film Coating, Encapsulation, or Pharmacy/Pre-Weigh Dispensing. Certifications, Licenses, Credentials: • N/A Skills & Ability • Demonstrates ability to work in a team and assist others., • Bi-Lingual in Spanish or Hindi is a plus., • Able to follow written instructions precisely and perform basic math calculations as required., • Understands and is knowledgeable of cGMP, OSHA standards etc., • Mechanically inclined to understand inner workings of equipment., • Demonstrates the ability to read and write basic English in order to be able to understand the industry regulated instruction sheets. Physical Requirements (lifting, etc.): • Ability to lift up to 50 lbs.; occasionally lift and move up to 75 pounds., • Must stand and walk on production floor a minimum of 6 hours per shift, • Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from waist, or squatting, walking short distances., • Occasionally works from a rolling ladder or step stool., • Must be able wear all PPE including lab coat, face mask, booties, gloves, safety glasses/goggles and respirators. Work Environment (Office, Warehouse, temperature extremes, etc.): • Work is regularly performed inside a manufacturing environment where temperatures can be moderate, exposure to dust, odors, noise and fumes. The noise level is usually moderate. Employee can be exposed daily to chemicals and cleaning agents. 2nd shift 3:15 PM to 11:45 PM

Job Description Job Description Date 2026 Location 1200 Airport Road, North Brunswick NJ Title Senior Manager, R&D Department Research & Development Reports to VP, Research & Development FLSA (Exempt or Non-Exempt Exempt Role Overview The Senior Manager, R&D will lead multiple product development programs through the research, scale-up, and commercialization process while ensuring adherence to cGMPs, SOPs, FDA requirements, and customer expectations. This individual will provide technical and managerial leadership to the R&D team, oversee development priorities, manage complex projects, and partner closely with Production, Quality, Regulatory, Procurement, and Commercial teams. The Senior Manager, R&D will play a critical role in building and executing integrated development plans, improving department capabilities, mentoring team members, and supporting the company’s strategic growth and innovation initiatives. The duties and responsibilities described are not limited to those outlined and are not intended to be a comprehensive list of all activities, functions, or responsibilities required of the position. Additional duties and responsibilities may be assigned as required. This position requires travel for customer visits and trade shows, both within the United States and internationally, as needed to support business objectives. Areas of Responsibility Leadership & Strategy • Lead and manage the R&D function for new product development, reformulations, and line extensions., • Supervise, coach, and develop a team of formulation scientists, chemists, and R&D associates., • Establish department priorities, allocate resources, and ensure project timelines are achieved., • Collaborate with senior leadership to define product strategy, innovation pipeline, and technical direction., • Drive continuous improvement initiatives related to product development, manufacturing processes, and departmental efficiency., • Serve as the technical lead and subject matter expert for formulation and process development activities. Product Development & Commercialization • Oversee development and commercialization of nutraceutical products including capsules, tablets (monolayer, bilayer, trilayer), beadlets, powders, stick packs, and other specialty dosage forms., • Develop robust formulations and scalable manufacturing processes for dietary supplements and nutraceutical products., • Research and evaluate new ingredients, technologies, excipients, delivery systems, and product claims., • Lead feasibility assessments, prototype development, and technical evaluations for new business opportunities., • Design and direct laboratory experiments, pilot studies, and process optimization activities., • Recommend alternative ingredients and/or process improvements to enhance product quality, manufacturability, cost, and efficiency., • Scale up pre-exhibit and exhibit batches to commercial manufacturing and lead technology transfer from R&D to Production., • Coordinate manufacturing start-up activities and provide floor support during scale-up and initial production runs. Regulatory, Compliance & Documentation • Ensure all product development activities comply with applicable SOPs, FDA regulations, dietary supplement regulations, and Current Good Manufacturing Practices (cGMPs)., • Create, review, and approve SOPs, technical documents, formulas, specifications, validation protocols, and product development reports., • Review batch records, process characterization studies, validation reports, deviations, CAPAs, and investigation reports., • Prepare and review technical briefs, ingredient specifications, risk assessments, and customer-facing development summaries., • Support internal and external audits, customer visits, and regulatory inspections., • Maintain accurate and complete project documentation in accordance with company standards. Cross-Functional Collaboration • Partner closely with Production, Quality Assurance, Quality Control, Regulatory Affairs, Procurement, Supply Chain, Sales, and Marketing teams., • Present technical findings, risks, recommendations, and project status updates to cross-functional teams and leadership., • Identify and proactively communicate development risks, technical issues, and timeline impacts., • Work with vendors and suppliers to identify and qualify new raw materials and technologies., • Support business development and customer meetings by providing technical expertise and formulation recommendations. Additional Responsibilities • Monitor industry trends, emerging ingredients, formulation technologies, and competitive products., • Develop and manage project timelines, budgets, and department metrics., • Assist with annual planning, capital requests, and staffing needs for the R&D department., • Perform other duties and special projects as assigned. Other Responsibilities Including Safety: • Comply with all job-related safety and other training requirements. Requirements Education & Qualification: • Master’s degree in Pharmaceutical Sciences, Chemistry, Food Science, Chemical Engineering, or a related scientific discipline required., • OR a combination of education and experience equivalent to the above requirements., • 8–12+ years of progressive experience in product development, formulation, and commercialization within the nutraceutical, dietary supplement, pharmaceutical, or CDMO industry., • Minimum 3–5 years of leadership or people management experience., • Strong experience with tablets, capsules, powders, beadlets, and related dosage forms., • Proven experience in scaling products from laboratory through commercial manufacturing., • Experience working in a fast-paced contract manufacturing or CDMO environment strongly preferred. Certifications, Licenses, Credentials: • N/A Skills & Ability • Thorough understanding of cGMPs, FDA regulations, dietary supplement regulations, and product development processes., • Strong technical knowledge of formulation science, process development, scale-up, and manufacturing., • Excellent leadership, coaching, and project management skills., • Strong analytical and problem-solving abilities with the ability to interpret complex technical data., • Excellent written and verbal communication skills., • Ability to manage multiple projects simultaneously and meet aggressive timelines., • Strong organizational and cross-functional collaboration skills., • High level of ethics, integrity, professionalism, and confidentiality., • Proficient in Microsoft Office and ERP/document management systems.Able to maintain a professional and positive attitude., • Able to maintain confidentiality and possess a high level of ethics and integrity. Physical Requirements (lifting, etc.): • The employee is frequently required to sit (50%), stand, and walk (50%). Uses hands to finger, handle or feel writing tools and computer keyboard. May reach with hands and arms and infrequently may lift up to 30lbs. Use desk telephone/cell phone to talk and hear or converse with other employees. Work Environment (Office, Warehouse, temperature extremes, etc.): • Primarily located in an office environment where temperatures are controlled for heat and air conditioning. Occasionally walks through warehouse or manufacturing workplace and will be required to wear appropriate PPE for each work area including safety shoes, hair net, safety glasses, face mask, gloves, or disposable jumpsuit. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.

Job Description Job Description Date 10/2025 Location 1200 Airport Road, North Brunswick NJ Title Technician, R&D Formulation Department Research & Development Reports to Director, Research & Development FLSA (Exempt or Non-Exempt Non-Exempt Role Overview The Formulation Technician is responsible for supporting the formulation and manufacturing processes by accurately weighing, mixing, and processing raw materials in accordance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (cGMP), and batch documentation requirements. This role involves hands-on operation and maintenance of various pharmaceutical production equipment and requires close adherence to quality, safety, and regulatory standards. Areas of Responsibility Technician, R&D -Level 1, Works under close supervision; learns formulation procedures, documentation, and equipment operation. Technician, R&D -Level 2 Works independently on complex formulation and scale-up activities; may train junior staff Technician, R&D -Level 3 Operates with minimal supervision; recognized technical expert and mentor within the R&D team. Develops and updates SOPs, batch records, and training materials. Oversees equipment readiness, preventive maintenance, and calibrations. Mentors’ technicians and ensures high-quality documentation and compliance. Supports technology transfer and production readiness reviews Key Responsibilities Level 1, 2 & 3 • Accurately weigh and transfer raw materials using calibrated balances and scales in accordance with approved batch records and formulation guidelines., • Perform formulation and manufacturing activities for pilot, scale-up, and commercial batch production., • Operate equipment for mixing, blending, granulation, and other material processing functions in support of pharmaceutical product development and manufacturing., • Complete and maintain accurate, compliant, and timely documentation, including Batch Manufacturing Records (BMRs), Logbooks, Protocols, and related forms in accordance with cGMP and SOP requirements., • Assist in the development and optimization of formulations for various dosage forms such as tablets, capsules, and granules, under the direction of senior formulation scientists or supervisors., • Independently execute and monitor benchtop, pilot-scale, and manufacturing scale-up batches with minimal supervision., • Set up, operate, clean, and perform changeovers on R&D and pilot-scale manufacturing equipment, including but not limited to:, • Tablet Presses, • Capsule Filling Machines, • Coating Machines, • Granulators, • Fluid Bed Dryers (FBDs), • Ensure equipment is properly maintained, sanitized, and operated in compliance with SOPs, safety protocols, and current Good Manufacturing Practices (cGMP)., • Proactively identify and troubleshoot issues during formulation development, demonstrating strong problem-solving skills and an ability to anticipate potential risks or failures., • Adhere strictly to all company policies, safety guidelines, and regulatory requirements., • Participate in routine housekeeping, equipment cleaning, and 5S/continuous improvement initiatives to maintain a safe and efficient working environment., • Perform additional duties and responsibilities as assigned by management to support departmental and organizational goals. Requirements Education & Qualification: Technician, R&D -1 • Requires High School diploma or GED, Associate degree preferred., • 1 to 4 years of experience working in a nutraceutical/pharmaceutical, biotech, or food manufacturing environment, regulated by GMP standards and requirements., • Specific experience in oral solid dosage manufacturing, blending, compression, pan coating, fluid bed, or encapsulation manufacturing processes will be a plus. Technician, R&D -2 • Requires High School diploma or GED, Associate degree preferred., • 6 to 10 years’ experience working in a nutraceutical/pharmaceutical, biotech, or food manufacturing environment, regulated by GMP standards and requirements., • Specific experience in oral solid dosage manufacturing, blending, compression, pan coating, fluid bed, or encapsulation manufacturing processes. Technician, R&D -3 • Associate’s or Bachelor’s degree in Chemistry, Biology, Engineering, or related scientific field, • 3 to 12 years’ experience working in a nutraceutical/pharmaceutical, biotech, or food manufacturing environment, regulated by GMP standards and requirements., • Specific experience in oral solid dosage manufacturing, blending, compression, pan coating, fluid bed, or encapsulation manufacturing processes. Certifications, Licenses, Credentials: • N/A Skills & Ability • Requires hands-on experience or knowledge to set-up & operate Tablet, Capsule, Granulation manufacturing process equipment such as Tablet Press, Capsule Filling, Coating, Granulator, Fluid Bed Dryers, etc. and the ability to troubleshoot this equipment., • Utilizes problem-solving skills to investigate and troubleshoot product issues and recommend solutions for issues such as sticking, picking, capping, chipping, compressibility, delamination, etc., • Works independently or in a team assisting others., • Performs basic math calculations and follow written instructions with accuracy and pay attention to detail., • Able to follow and understand cGMP, OSHA standards etc., • Able to distinguish different shades of colors., • Intermediate user of MS Office, Excel, Word, and Outlook, • Complies with all regulatory/ in-house requirements (may include but not be limited to safety, housekeeping, laboratory chemical waste, cGMP’s, GLP, documentation) when performing the assigned activity., • Demonstrates above average written communication skills in the English language to follow the industry regulated instruction sheets. Physical Requirements (lifting, etc.): • The employee is frequently required to sit (50%), stand, and walk (50%) at a lab bench., • Able to lift up to 35 lbs.; occasionally lift and move up to 50 pounds., • Able to stand and walk on the production floor a minimum of 6 hours per shift., • Uses hands to finger, handle or feel, or to operate or to control objects. Able to lift up to waist height and/or above shoulder height, frequent bending from waist, or squatting, walking short distances., • Able to occasionally work on a rolling ladder or step stool, or to lean over equipment as well as kneeling on the floor to clean under the equipment., • Able to wear all PPE including lab coat, face mask, booties, gloves, safety glasses/goggles and respirator. Work Environment (Office, Warehouse, temperature extremes, etc.): • Work is regularly performed inside a laboratory environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents., • Occasionally walks through warehouse or manufacturing workplace and will be required to wear appropriate PPE for each work area. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an “at will” relationship. USPL is proud to be an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law. Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment. Job Description Acknowledgement I have read and understand the job requirements, responsibilities, and expectations set forth in the job description provided for my position. I attest that I can perform the essential job functions as outlined with or without any reasonable accommodation 9:00 am to 5:30 PM

Job DescriptionJob Title: Laboratory Operations AssistantJob Description The Laboratory Operations Assistant supports a busy quality control laboratory by maintaining a clean, safe, and well-organized environment. This role focuses on cleaning and handling laboratory glassware, managing waste and decontamination processes, and helping to maintain inventory and supplies. It is an excellent opportunity for someone with a foundational background in science or chemistry who wants to gain hands-on experience in a fast-paced pharmaceutical laboratory. Responsibilities • Continuously clean laboratory glassware using automated cleaning machines and scrubbers as needed, and organize and store cleaned glassware in appropriate storage cabinets or designated areas., • Clean laboratory floors and benches on a regular basis to maintain a safe and orderly work area., • Remove garbage from the laboratory area promptly and discard laboratory-generated waste into designated waste collection containers in accordance with established procedures., • Ensure laboratory supplies are stocked daily and arrange incoming items in their designated locations to support First In, First Out (FIFO) usage., • Help maintain optimal laboratory inventory levels by receiving shipments and accurately logging materials in the material receiving logbook., • Occasionally place orders for laboratory supplies when requested or when inventory levels require replenishment., • Support microbiology activities by gathering post-testing reject samples for decontamination, running autoclave cycles for sterilization and decontamination, washing decontaminated glassware, organizing cleaned glassware for drying, and returning dried glassware to its proper storage locations., • Follow written and verbal procedures and instructions to ensure compliance with laboratory protocols and safety requirements., • Perform any other duties as requested by laboratory management to support overall laboratory operations and the quality control team.Essential Skills, • High School Diploma or GED is required., • Associate of Science degree or a degree in a technically related field is preferred., • background in chemistry or a chemistry-related field is strongly preferred., • 1–2 years of experience working in a laboratory, preferably in a food, drug, or chemical laboratory, is required., • Basic understanding of chemistry, samples, raw materials, and pharmaceutical laboratory practices., • Inventory management experience, including organizing, stocking, and tracking laboratory supplies., • Hands-on experience washing and handling glassware in a laboratory setting., • Computer skills sufficient to log materials, track inventory, and follow electronic procedures., • Ability to read, write, and communicate in English at a level that supports understanding laboratory terminology and instructions., • Good communication skills with the ability to comprehend and follow written and verbal procedures or instructions., • Basic math skills at an intermediate level to support inventory and measurement-related tasks., • Ability to work flexible schedules and perform overtime as needed to support laboratory operations.Additional Skills & Qualifications, • High School Diploma or GED is preferred as an educational baseline., • Less than one year of experience in pharmaceutical or cleaning environments is preferred for entry-level candidates who are eager to learn., • Comfort working with laboratory equipment such as cleaning machines, scrubbers, and autoclaves., • Ability to handle repetitive tasks while maintaining attention to detail and quality., • Strong organizational skills to manage glassware, supplies, and inventory in a structured manner., • Reliability and willingness to support the broader quality control team with various operational tasks., • Interest in developing skills in a pharmaceutical laboratory environment that includes exposure to multiple dosage forms such as solids, semi-solids, liquids, suspensions, thermal products, inhalation products, and injectables.Work Environment This role is based in a fast-paced generic pharmaceutical quality control laboratory, working on a first shift schedule from approximately 8:00 a.m. to 4:30 p.m. The position requires flexibility to work occasional weekends and stay late when needed to support testing and operational demands. The Laboratory Operations Assistant will work as part of a quality control team of roughly 15–20 people in an environment that emphasizes safety, cleanliness, and adherence to established procedures. The laboratory uses a wide range of technologies and dosage forms, including solid, semi-solid, liquid, suspension, thermal, inhalation, and injectable products, offering broad exposure and a strong training program. The setting is professional, structured, and highly regulated, with a focus on accuracy, timeliness, and collaboration. Job Type & Location This is a Contract position based out of PISCATAWAY, NJ. Pay and Benefits The pay range for this position is $19.00 - $19.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in PISCATAWAY,NJ. Application Deadline This position is anticipated to close on Sep 25, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law. If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email actalentaccommodation@actalentservices.com for other accommodation options. San Francisco Fair Chance Ordinance:Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records. Massachusetts Lie Detector:It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI):We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.

Job Description Position Description: Position SummaryThe QA Inspector I is responsible for supporting Quality Assurance activities by ensuring products are manufactured, packaged, and released in compliance with current Good Manufacturing Practices (cGMP), FDA regulations, company Standard Operating Procedures (SOPs), and applicable quality standards. This role performs in-process inspections, material sampling, line clearance, documentation review, equipment verification, and quality monitoring throughout manufacturing and packaging operations.Essential Duties and ResponsibilitiesEnsure compliance with current Good Manufacturing Practices (cGMP), FDA regulations, company SOPs, and quality standards during all phases of manufacturing and packaging operations.Perform sampling of raw materials, packaging materials, in-process materials, finished products, microbiological samples, validation samples, stability samples, and controlled samples in accordance with approved procedures.Review incoming raw material and packaging material documentation for completeness, accuracy, and compliance with established procedures.Prepare, issue, and maintain receipt, quarantine, and release labels for raw materials and packaging components.Perform routine calibration verification of in-house balances and maintain calibration records.Conduct room clearance, equipment clearance, and manufacturing and packaging line clearance inspections prior to production activities.Perform in-process quality inspections during manufacturing and packaging operations according to batch manufacturing records (BMRs), batch packaging records (BPRs), and established procedures.Collect, prepare, label, and submit bulk and finished product samples for Quality Control testing and QA retain samples.Review manufacturing and packaging logbooks for completeness, accuracy, and compliance.Perform equipment swab sampling and cleanliness verification as required.Verify packaging labels, printed components, and packaging materials before production begins.Verify cleaning activities have been completed before manufacturing or packaging equipment is released for use.Conduct visual inspections of labeling components and prepare inspection documentation.Issue labeling components according to packaging orders and monitor label room activities for compliance.Review batch manufacturing and packaging documentation for completeness, proper signatures, data accuracy, reconciliations, yields, and compliance before authorizing progression to the next processing step.Maintain proper storage, issuance, periodic inspection, and destruction of retain samples in accordance with SOPs.Verify functionality and operational readiness of manufacturing and packaging equipment and associated controls during production.Utilize business systems and software including Microsoft Office, SYSPRO, Rite-Scan, QR Code systems, and other electronic applications to document and track quality activities.Promptly report quality issues, deviations, or non-conformances to QA management.Support internal audits, inspections, investigations, and continuous improvement initiatives as assigned.Perform other duties and responsibilities as assigned.Education & Experience:High school diploma or equivalent required; an Associate's degree in a scientific or technical field is preferred.1-2 years of experience in Quality Assurance, Quality Control, manufacturing, or another regulated industry; pharmaceutical or dietary supplement experience is preferred.Basic knowledge of current Good Manufacturing Practices (cGMP), FDA regulations, Good Documentation Practices (GDP), and quality systems.Strong attention to detail with the ability to accurately inspect materials, review documentation, identify discrepancies, and maintain accurate records.Proficient in Microsoft Office applications and able to learn and effectively use ERP and quality management systems such as SYSPRO, Rite-Scan, barcode/QR code systems, or similar software; strong communication, organizational, and teamwork skills.

Job Description Position Description: Position Summary:The Quality Control Chemist-I is responsible for conducting routine testing and analysis of raw materials, in-process materials, and finished product samples using various analytical methodologies to ensure the quality of dietary supplements and OTC products. This role includes reviewing and maintaining Standard Operating Procedures (SOPs), Testing Procedures, calibrations, and other controlled documents to ensure compliance with regulatory standards and internal procedures. Additionally, the Chemist-I will assist in quality control stability testing and contribute to maintaining accurate records and documentation.DUTIES AND RESPONSIBILITIES:Ensure all work is performed in compliance with cGMP, GLP, compendia standards, and internal procedures. Conduct wet chemistry and analytical testing on raw materials, finished products, in-process samples, stability, and packaged products according to Testing Procedures.Assist in quality control stability testing, prepare, and maintain stability records and summaries.Operate, maintain, and troubleshoot analytical instruments, including pH meter, FTIR, TOC, UV, and others as necessary.Maintain accurate records of all analyses, ensuring contemporaneous documentation and adherence to company standards.Perform laboratory analysis right the first time and ensure all results are properly documented.Conduct laboratory investigations under the guidance of laboratory management.Work effectively under the direction of supervisors and/or manager, and perform additional duties as required.QUALIFICATION AND EXPERIENCE:Bachelor’s degree in chemistry, Biochemistry, Pharmaceutical Sciences, or related field with 0 - 3 years of relevant experience in a quality control setting; or an equivalent combination of education and experience.Basic understanding of Current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and quality control principles in the pharmaceutical industry.Math skills commensurate with a scientific background are required.Ability to communicate test results and observations clearly, both verbally and in writing. Ability to follow written instructions and solve basic analytical problems using standard procedures.

Job Description Job Summary The Regulatory Affairs Strategist is responsible for developing and executing regulatory strategies that support the approval and lifecycle management of pharmaceutical products. This role serves as a key liaison between the company and regulatory agencies, ensuring compliance with applicable regulations while facilitating timely submissions for clinical trials, marketing authorizations, and post-approval changes. Working cross-functionally with R&D, Clinical, Quality, CMC, and Commercial teams, the strategist provides regulatory guidance throughout all phases of product development. The ideal candidate will possess strong working knowledge of FDA regulations (including IND and NDA processes), international regulatory environments, and experience preparing regulatory documentation. This position requires strategic thinking, attention to detail, and the ability to navigate complex regulatory frameworks to support innovation and business goals. Job Responsibilities • Develop & implement regulatory strategies across product pipelines, including NDAs, BLAs, and supplements., • Draft and submit regulatory documents (e.g. INDs, NDAs, CTAs) to the FDA and international agencies (Canada, Europe, UK)., • Interpret and apply regulations (FDA, ICH, cGMP, USP standards) and monitor changes that may affect product development., • Provide regulatory guidance to cross-functional teams—R&D, clinical, CMC, quality, and commercial., • Maintain submission tracking systems, regulatory databases, and filings., • Interact with regulatory agencies, managing agency correspondence, meetings, and scientific advice requests., • Identify and mitigate regulatory risks, ensuring compliance and protecting timeline integrity., • Support global strategies, including alignment with non U.S. jurisdictions where applicable., • Lead and manage responses to Health Authority information requests., • Work with CROs, consultants, and the internal team as required to plan, manage, and support regulatory deliverables related to US and EX-US submissions for assigned projects., • Interface with senior management to provide project updates., • Anticipate regulatory risks and propose mitigation strategies., • Coordinate and prioritize assigned projects according to company goals. Qualifications • Advanced degree in a scientific discipline required (Life Sciences, PharmD, Regulatory Affairs, or related)., • RAC certification is a strong plus., • 5+ years of regulatory affairs experience—pharma, biotech, or medical devices., • Deep knowledge of FDA requirements and global regulations., • Track record in preparing and submitting regulatory filings., • Proficient in project management, communication, and negotiation., • Experience with submission platforms, eTMF, and regulatory databases., • Excels at cross-functional collaboration and facilitates effective communication and alignment across diverse teams., • Excellent oral and written communication skills., • Experience developing and implementing successful regulatory strategies., • The candidate should be detail oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment. The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary. As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This position has an expected base salary range of $140,000 - $160,000 annually

Job Description Job Description Date 2025 Location 1300 Airport Road, New Brunswick New Jersey Title Associate, Purchasing Department Operation (Purchasing) Reports to Senior Manager, Purchasing & Sourcing FLSA (Exempt or Non-Exempt Exempt Role Overview The Purchasing Associate ensures the timely procurement of materials and components, manufacturing equipment, lab supplies, warehouse, and office supplies across all facilities. Areas of Responsibility • Issue Purchase orders in the ERP system for Raw Materials and/or packaging materials and sending them out to respective vendors., • Issue Purchase orders in the ERP system for consumable goods to support manufacturing, engineering, Lab, and Warehouse across all facilities and sending them out to respective vendors., • Ensure full compliance with Company policies, procedures, GMP’s, Ethical Business Practice, and SOPs at all times., • Work closely with the planning team and Purchasing manager to ensure the accuracy of Purchase orders issued in the ERP system., • Work in a safe and responsible manner in order to create an injury-free and incident-free workplace., • Comply with all job-related safety and other training requirements., • Keep management informed of area activities and of any significant problems., • Other duties as assigned. Requirements Education & Qualification: • Relevant supply chain or purchasing experience (preferably in a similar industry such as Pharmaceutical or Nutraceutical). Knowledge, Skills, and Abilities: • Able to read, write and speak English sufficiently., • Strong project management and leadership skills., • Comfortable with figures and in collecting, analyzing, and interpreting data., • Solid judgment with ability to make good decisions., • Ability to interact effectively with different departments and with all levels of management., • Must know MS Office, particularly Excel., • Knowledge of ERP systems (Syspro, SAP) preferred., • Bi-Lingual in either Chinese or Hindi is a plus. Physical Requirements (lifting, etc.): • Ability to navigate office, lab, and/or plant floor working environments., • Standard office environment without unpleasant or hazardous conditions. Physical demands involved in office work such as the ability to talk, hear, use hands to hold and feel; work on a computer up to 7-8 hours a day; close vision required for computer usage., • Must have the ability to wear applicable personal protective equipment utilized at this site, including safety glasses/goggles, hair nets, lab coats, and safety shoes. Work Environment (Office, Warehouse, temperature extremes, etc.): • Exposed to lab and/or plant floor working environments., • Standard office environment without unpleasant or hazardous conditions., • Temperature controlled for heat and air conditioning. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship. USPL is proud to be an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law. Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including medical, dental, vision, short- and long-term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation in the first year, which grows to 12 days starting the second year of employment. Job Description Acknowledgement I have read and understand the job requirements, responsibilities, and expectations set forth in the job description provided for my position. I attest that I can perform the essential job functions as outlined with or without any reasonable accommodation. 1st shift - 9:00 AM to 5:30 PM

Job Description Job Title: USA_Regulatory Associate - Level 3 Location: Warren, NJ Type: 12-month contract Compensation: $49.15 hourly Work Model: Hybrid – 2-3 days onsite Hours: 8am-5PM Overview: The purpose of this role is to execute OTC regulatory activities for new products registrations and life-cycle. Maintenance for the portfolio of products defined by the US Business Units. Responsibilities • Represent USRA on assigned projects, provide guidance on OTC drug regulatory pathways (monograph, NDA). • Develop regulatory strategies and documents for new product launches and maintenance of current products aligned with the regulations. • Develop regulatory label for OTC products, review claims and copy. • Participate in the review of promotional materials. • Support end-to-end regulatory compliance of products in remit. • Apply system and procedure updates to maintain up-to-date technical product records. • Identify and participate in process improvements within US Regulatory Affairs. • Interact with colleagues in other global functions to support global programs. • Effectively communicate regulatory technical requirements and guidelines, facilitating timely and complete submissions. • Develop up-to-date knowledge of guidelines and regulatory requirements, as well as technical trends. Requirements • Bachelor’s degree in Pharmaceutical or Life Sciences or equivalent regulatory experience. • 2-4 years’ experience in regulatory affairs including chemistry, manufacturing and controls, and OTC experience, preferably within a CPG/Consumer Healthcare/Pharma related industry. • Experience and knowledge in Quality, product development and manufacturing areas. • Experience working on FDA applications, OTC monograph products, chemistry, manufacturing and controls. • Proficient knowledge in US FDA regulations. • Excellent communication skills, stakeholder management, and ability to work in multidisciplinary teams. • Ability to manage and prioritize projects of high complexity. • Experience leading end-to-end regulatory processes in new product launches. • Additional Preferred Qualifications: knowledge of US regulatory framework for OTC drugs and devices, ensuring compliance standards, and regulatory lifecycle expertise. • Minimum 2 years of experience in regulatory affairs. • Competencies include agility, attention to detail, strong written and verbal communication skills, evidence-based decision making, and risk evaluation. System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. #M- #LI- Ref: #568-Clinical

Job Description About GenScript Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions. Job Title: Procurement Lead, Direct Materials Location: Piscataway, NJ (4 Days onsite with remote flexibility on Fridays) Reports to: Senior Procurement Manager Compensation: The estimated salary range is $100,000 - $110,000, based on experience. Job Overview: The role is responsible for leading the direct procurement team, managing end-to-end sourcing and procurement of direct materials and consumables to support production. Key duties include ensuring daily operations meet SLA and KPI targets, overseeing material planning for critical items, and driving strategic sourcing initiatives. The candidate will manage vendor relationships, negotiate contracts, and identify cost-saving opportunities through category management and market analysis. Close collaboration with cross-functional teams is essential to ensure supply continuity, compliance with quality and regulatory standards, and readiness for audit requirements. The ideal candidate is able to thrive in a high-volume and fast-paced environment, and has managed projects and initiatives from end to end. Job Responsibilities: • Supervise the direct procurement team to ensure smooth daily operations and compliance with SLA and KPI targets, and effectively manage team performance., • Oversee material planning for Green Channel item replenishment to meet inventory KPIs while ensuring continuity of supply., • Lead strategic sourcing and manage the procurement process for direct materials and consumables used in production, ensuring alignment with cost objectives, quality standards, and regulatory requirements., • Develop alternative vendors for critical materials and components to ensure supply continuity and mitigate supply chain risks., • Conduct category management to identify cost-saving opportunities through vendor consolidation and the use of alternative materials or components., • Leverage negotiation, analytical, and market research skills to drive value through cost reduction initiatives. Track and report KPIs related to cost savings, cost avoidance, on-time delivery (OTD), and efficiency improvements., • Execute vendor management by building supplier profiles, conducting regular business reviews, and securing both short- and long-term pricing contracts and Master Supply Agreements (MSAs)., • Serve as the primary point of contact for negotiating and executing contracts and agreements in coordination with the legal team., • Collaborate closely with production team to provide effective procurement support by understanding production processes, tracking changes in material consumption, and proactively addressing critical issues with urgency., • Maintain active communication with suppliers of critical materials to stay updated on market conditions, ensure timely deliveries, and identify potential risks and opportunities., • Work cross-functionally with quality, finance, and other departments to ensure procurement processes remain compliant with company policies and regulatory standards., • Respond to internal and external audit challenges by providing complete and accurate procurement documentation and justifications. Qualifications: • Bachelor's degree or higher in Business, Supply Chain Management, Biology and Chemistry, or other related fields., • 3-5 years of experience in procurement, strategic sourcing or planning of direct materials, preferably in the biotech or pharmaceutical industries, • Demonstrated leadership through previous experience in people management or project management, • Strong negotiation, analytical, and communication skill., • Good knowledge of materials used in biotech/pharma production, including raw materials, consumables and packing materials., • Ability to effectively communicate complex situations and demonstrate agility in identifying opportunities for cost reduction and problem-solving., • Proficiency in ERP systems of SAP and S2P is a plus #LI-EB1 #GS Benefits: Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. GenScript USA Inc./ProBio Inc. maintains a drug-free workplace. Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Job Description Position Description: Position Summary:The Procurement Buyer is responsible for managing the end-to-end procurement process for raw materials, excipients, packaging components, equipment, and services required for pharmaceutical manufacturing operations. This role combines transactional purchasing with strategic sourcing and supplier management to ensure uninterrupted supply, regulatory compliance, and cost efficiency. The Procurement Buyer works closely with cross-functional teams — including Planning, Quality Assurance, Regulatory Affairs, and Production — to support production schedules, new product launches, and continuous improvement initiatives.ESSENTIAL DUTIES AND RESPONSIBILITIES:•\tSource, negotiate, and purchase raw materials, excipients, packaging components, equipment, and services in compliance with cGMP, FDA, and company quality standards.•\tManage the full procurement cycle from request to purchase order issuance, delivery follow-up, and invoice reconciliation.•\tDevelop and maintain supplier relationships, evaluate performance, and implement improvement plans where necessary.•\tParticipate in supplier selection, qualification, and approval processes in collaboration with Quality and Regulatory teams.•\tLead price negotiations and contract discussions to secure competitive terms while ensuring quality and supply reliability.•\tMonitor and analyze market trends, lead times, and supplier capabilities to identify cost reduction and risk mitigation opportunities.•\tCollaborate with Production and Planning to forecast material requirements and ensure on-time availability while maintaining optimal inventory levels.•\tSupport new product development by sourcing new materials, packaging components, and technologies.•\tEnsure all procurement activities comply with internal SOPs, documentation standards, and regulatory requirements.•\tMaintain accurate procurement records, supplier documentation, certificates of analysis, and contracts in ERP or procurement systems.•\tContribute to continuous improvement initiatives aimed at enhancing procurement processes, supplier performance, and overall supply chain efficiency.QUALIFICATIONS AND DESIRED SKILLS: •\tBachelor’s degree in supply chain management, Business Administration, or a related field (or equivalent experience).•\t3+ years of procurement or purchasing experience, preferably in a pharmaceutical or GMP-regulated manufacturing environment.•\tStrong knowledge of cGMP, FDA, and other relevant regulatory requirements.•\tProven negotiation, communication, and supplier management skills.•\tProficiency with ERP or MRP systems and Microsoft Office Suite.•\tExcellent analytical skills with attention to detail and compliance.•\tAbility to work collaboratively with cross-functional teams and manage multiple priorities in a fast-paced environment.

Job DescriptionDescription:Associated Fire Protection is seeking a skilled Fire Sprinkler Technician to join our team. As a Fire Sprinkler Technician, you will be responsible for installing, inspecting, testing, performing repairs and maintaining fire sprinkler systems, as well as various types of fire protection systems and equipment as needed. About Us Associated Fire Protection, founded in 1947, is a leader in fire protection and life safety. We have offices located through New Jersey and New York. We are seeking motivated individuals to join our growing team. While previous experience in fire protection is a plus, we are also looking for people looking to make a change to an industry that is dedicated to protecting lives and property. We are very passionate about our work, but understand that our family, friends and other interests play an important role in our lives. If you are thinking about making a change, give us a shout. Essential Functions- including but not limited to: • Perform installation, testing, repair, inspections, on sprinkler systems, and other types of fire protection systems and equipment as needed, in compliance with electrical and fire safety codes., • Ensure systems are functioning correctly and address any issues that arise., • Ensure that all systems meet local and national fire safety regulations., • Troubleshoot fire sprinkler systems., • Complete inspection reports and repair work orders via mobile device and submit them on a timely basis., • Ability to read blueprints., • Pull material for jobs as required., • Communicate with customers to review work and answer any service, quality or technical questions., • Other job specific functions may be required depending on level., • Participate in on-call rotation for emergency service. General Functions • This position includes a lot of interaction with customers and coworkers. The successful candidate must be able to communicate effectively and enjoy collaboration with others., • The successful candidate should read and be aligned with company’s mission statement, vision and values., • Depending on skill level, the successful candidate must be able to manage, lead and mentor people. Requirements: Qualifications, Experience and Education- including but not limited to: • Minimum of 1-2 years of experience working on fire sprinkler systems, or related systems is required., • Must be able to obtain any licenses or certifications as required in the area that you are working., • Experience working with fire protection and suppression systems is required., • Perform simple tasks independently., • Knowledge of local and national fire protection codes., • Excellent customer service skills., • Strong problem-solving skills., • Ability to work independently and as part of a team., • Computer, phone and tablet literate., • Well organized, self-motivated, flexible and a team player., • Ability to perform physical and mental functions of the job with or without a reasonable accommodation., • Must be able to drive to and from jobs and have a valid driver's license., • Must be able to work flexible hours and overtime as needed., • Emergency Service shifts are a requirement for this job. Qualified candidates must be able to respond to NY emergency service calls., • Ability to work on Job sites that may include construction sites and other locations where personal protective equipment will be required, and work in confined spaces., • The position has frequent periods of stress., • Job sites may include schools, hospitals, jails, pharmaceutical companies and other companies that may require additional background checks and medical and drug screens. Benefits Offered • This position offers benefits including Medical Care, Dental Care, and Vision Care., • Competitive pay., • Paid time off (PTO) and sick leave., • Supplemental Life and Supplemental Insurance., • Flexible spending (FSA), medical, dependent care (DCA), and commuter benefits., • 401k. DISCLAIMER: The physical efforts and working conditions are not limited to those listed in this job posting and may change at any time. Reasonable accommodation(s) may be made to enable individuals with disabilities to perform the described essential functions of the position. Additionally, the various job functions and requirements are not limited to the items listed here. Associated Fire Protection is an Equal Opportunity, including disability.

Job Description Position Description: Position Summary:The Packaging & Removal Operator is responsible for the removal, inspection, polishing, and packaging of finished products in accordance with approved Batch Manufacturing Records (BMRs), Master Batch Records (MBRs), Standard Operating Procedures (SOPs), and current Good Manufacturing Practices (cGMP). This position ensures product quality, compliance, and efficient operation of packaging processes while maintaining a safe and organized work environment.Essential Duties and Responsibilities:Perform removal, inspection, polishing, and packaging of finished products in accordance with approved BMRs, MBRs, SOPs, and cGMP requirements.Inspect products for defects and quality attributes, ensuring only acceptable products proceed through the packaging process.Operate packaging and removal equipment safely and efficiently according to established operating procedures and safety guidelines.Complete all required production documentation accurately, including batch records, inspection records, and equipment logs, following Good Documentation Practices (GDP).Maintain compliance with all cGMP requirements, operational procedures, cleaning procedures, safety regulations, and company policies.Perform shift handoffs, communicate production status effectively, and report product quality issues, equipment malfunctions, deviations, or safety concerns to supervision.Maintain equipment and work areas in a clean, organized, and inspection-ready condition, ensuring proper status labeling of equipment and materials at all times.Educational Qualifications and Experience:High School Diploma or equivalent required.Minimum of 1 year of experience in the pharmaceutical or related manufacturing industry.Knowledge of cGMP regulations and Good Documentation Practices (GDP).Proficient writing, mathematical, and communication skills.Ability to read, understand, and follow SOPs, BMRs, MBRs, and production instructions.Strong attention to detail and commitment to quality.Physical RequirementsAbility to stand and walk for extended periods.Ability to lift, carry, push, and pull up to 50 pounds.Frequent bending, reaching, twisting, and repetitive hand movements.Ability to visually inspect products for quality defects and packaging compliance.

Job DescriptionBenefits/Perks • Highly enriched & healthy work environment, • Excellent growth opportunities, • Competitive Pay, • Career AdvancementJob SummaryWe are seeking an experienced Quality Assurance Specialist to join our team. In this role, you will be responsible for overseeing the quality of goods and services our company provides. You will perform routine inspections, implement quality assurance policies and procedures, and identify any workflow issues. The ideal candidate is an excellent verbal and written communicator with strong attention to detail. Position Summary The Quality Assurance Specialist – Clinical Trial Supply plays a critical role in ensuring the quality, safety, integrity, and compliance of clinical trial materials throughout their lifecycle—from receipt and storage to packaging, labeling, distribution, and returns. This role supports GxP operations, oversees Quality System activities, and collaborates cross-functionally with Operations, Warehouse, Packaging, Project Management, and external suppliers/CROs to maintain compliance with FDA, EU-GMP, GDP, ICH-GCP, DSCSA, and internal JRS standards. The QA Specialist ensures that all products and processes meet regulatory and customer expectations while supporting JRS’s mission to deliver reliable, resilient, and high-quality clinical supply solutions worldwide. Key Responsibilities 1. Quality Systems & Compliance • Ensure compliance with GMP, GDP, GCP, ICH, FDA, EMA, MHRA, TGA, CDSCO and JRS internal SOPs., • Review, approve, and maintain controlled documents including SOPs, Work Instructions, Forms, Batch Records, Labeling Specs, and Packaging Records., • Support implementation and continuous improvement of Quality Management Systems (QMS) including Deviation Management, CAPA, Change Control, Training, and Document Control., • Participate in internal audits, customer audits, vendor qualifications, and regulatory inspections. 1. Clinical Supply Chain Quality Oversight • Perform QA review and approval of:, • Incoming clinical supplies (comparator drugs, IMPs, ancillary supplies), • Packaging and labeling activities, • Storage and temperature monitoring records, • Distribution documentation including shipping records, AWBs, and temperature logger data, • Verify completion and accuracy of Line Clearance, Batch Packaging Records (BPR), and Label Control Logs., • Review and approve EPCIS/DSCSA traceability files, CoA/CoC, pedigrees, and other regulatory documentation. 1. Investigations & Deviation Management • Lead or support investigations for:, • Temperature excursions, • Packaging or labeling discrepancies, • Shipment issues, • Supplier or customer complaints, • Perform root cause analysis (RCA), risk evaluation, and implement effective CAPAs. 1. Vendor & Customer Quality Support • Support supplier qualification by reviewing:, • GMP/GDP licenses, • ISO certifications, • Quality Agreements (QTA), • Questionnaires and risk assessments, • Collaborate with customers to ensure project-specific quality requirements are met. 1. Documentation & Regulatory Support • Ensure accurate completion of QA documentation related to:, • Clinical supply release, • Temperature-controlled shipping, • Storage of controlled and non-controlled materials, • Destruction, return, and reconciliation, • Maintain updated Quality and Technical Agreements (QTA) with clients and suppliers. 1. Training & Continuous Improvement • Deliver and maintain training programs for QA and Operations teams on:, • GDP/GMP compliance, • SOP revisions, • Packaging and labeling quality requirements, • Temperature control best practices, • Participate in continuous improvement initiatives to enhance operational efficiency and compliance. Required Qualifications • Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Chemistry, or related field., • 2–5 years of experience in Quality Assurance within Clinical Trial Supply, Pharmaceutical, Biotech, CRO, CDMO, or GMP/GDP warehouse environment., • Strong understanding of GMP, GDP, GCP, DSCSA/EPCIS, ICH guidelines, and clinical supply chain processes., • Experience with deviations, CAPA, change control, labeling review, packaging operations, and QA release. Preferred Qualifications • Experience working with temperature-controlled logistics (2–8°ree;C, -20°ree;C, CRT)., • Knowledge of comparator sourcing workflows and global distribution practices., • Familiarity with Quality Agreements, Supplier Qualification, and Vendor Audits., • Experience with Power BI, SharePoint QMS, and ERP/WMS systems., • Certification in GMP/GDP/GCP (optional but advantageous). Core Competencies • Strong attention to detail and documentation accuracy., • Excellent communication and problem-solving skills., • Ability to work cross-functionally and manage multiple priorities., • Proactive, organized, and committed to quality and compliance., • Ability to make decisions based on risk, data analysis, and regulatory expectations. Why Join Jupiter Research Services? • Work in a rapidly growing organization focused on resilient clinical supply chain solutions., • Gain exposure to global clinical trials, high-impact projects, and innovative supply models., • Contribute to a compliance-driven organization with strong customer and patient-centric values., • Opportunities for growth in Quality, Operations, Regulatory, and Project Management.

Job Description Title: Vice President, Quality, Compliance & Facilities FLSA: Exempt Position Overview: This role provides senior leadership and ownership of the functions that safeguard product integrity and the operating environment: Quality, Compliance (Quality Control, Quality Assurance, Safety and regulatory conformance), Security, and Facilities. The position is accountable for ensuring that products consistently meet quality specifications, that operations remain fully compliant with regulatory and safety standards, that the site and its products are secure, and that facilities are maintained to support a reliable 24/7 manufacturing environment. The role establishes clear metrics and ownership across these areas and reports performance to senior leadership. Key Responsibilities: • Quality: Establish and maintain quality control protocols for raw materials, components, and finished products. Design inspection and testing processes and provide guidance on maintaining consistent quality from the beginning of production through final release. Lead Quality Assurance and Quality Control teams, monitor quality metrics, and drive corrective and preventive actions (CAPA) to eliminate root causes of defects. Ensure conformance to customer, product, and industry specifications., • Compliance: Ensure full compliance of operations with ISO 9001, ISO 14001, and applicable safety standards in accordance with New Jersey law. Own audits, certifications, and documentation, and serve as the primary liaison with regulatory bodies, auditors, and customers on compliance matters. Identify potential risks and pitfalls (e.g., equipment failures or other disruptions) and develop strategies to mitigate these issues through process improvement, alternative suppliers of materials, or altered equipment., • Security: Oversee physical and product security programs consistent with the company's trust and authentication mission. Establish and enforce protocols to protect raw materials, work-in-process, finished goods, and sensitive assets throughout the facility and supply chain. Ensure operations meet payment-industry and customer security requirements, and manage security personnel and access controls across all shifts., • Accountability: Own the key performance indicators and reporting for quality, compliance, security, and facilities. Establish clear ownership, metrics, and dashboards, report performance to senior management, and foster a culture of accountability across the organization. Manage a team of approximately 35 people across 7 shifts supporting QA, Safety & Security., • Facilities: Oversee facility operations, maintenance, and environmental health and safety of the buildings, grounds, and utilities. Ensure facilities are maintained to support a reliable 24/7 manufacturing environment, manage facility vendors and contractors, and lead facility-related capital projects, space planning, and safe-workplace initiatives. Skills & Qualifications • Bachelor's or Master's degree in Engineering, Quality, Operations Management, or a related field., • A minimum of 10–15 years (or more) of relevant experience in quality, compliance, and/or operations leadership in a high-volume manufacturing environment (Pharmaceutical, Semiconductor, Automotive, or secure/payment products) , with at least 5-10 years experience in managing teams across multiple shift in a 24/7 environment :, • Deep knowledge of quality management systems (ISO 9001, IATF 16949 for automotive, AS9100 for aerospace, etc.), • Six Sigma / Lean methodologies (typically Black Belt or Master Black Belt level), • Root cause analysis and CAPA (corrective and preventive action) processes, • Statistical process control (SPC) and data-driven decision making, • Supplier quality management and audit experience, • Very strong analytical skill set, including familiarity with quality and reliability tools (e.g., FMEA, SPC, Kaizen)., • Regulatory fluency:, • OSHA, EPA, ISO 14001 (environmental), ISO 45001 (occupational health & safety), • Industrial hygiene and risk assessment methodologies, • Environmental compliance (emissions, waste management, hazmat handling), • Process safety management, • Incident investigation and workers' compensation/claims oversight, • Demonstrated experience working with cross-functional teams required., • Demonstrated experience in third party audits ( ISO , PCI, ....), • Occasional travel to suppliers and partners. Preferred Skills and Qualifications: • Quality certifications such as Black belt Six Sigma, • GHG Management, • Familiarity with ERP tools, • Experience in a secure payment, or otherwise highly regulated manufacturing environment. About CompoSecure CompoSecure, a GPGI business (NYSE: GPGI), is the leading manufacturer of Premium Metal Payment Cards and also offers best-in-class Authentication and Digital Asset solutions. The Company's offerings combine elegance, simplicity, and security to deliver exceptional experiences and peace of mind, enabling trust for millions of people around the globe. For more information, please visit www.CompoSecure.com and www.GetArculus.com. We offer a comprehensive benefits package designed to support your health, financial well-being, and work-life balance, including medical, prescription, dental, and vision coverage; FSA/HSA options; company-paid life and disability insurance; 401(k) with company match; paid time off (PTO) and holidays; annual bonus opportunities; an employee assistance program (EAP); and opportunities for career growth and advancement. Additional details will be provided during the hiring process. CompoSecure is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, or national origin. We are also an equal opportunity employer of individuals with disabilities and protected veterans. Please note: CompoSecure does not accept unsolicited resumes from staffing agencies or third-party recruiters. Any unsolicited resumes sent to CompoSecure, including to our employees, will become the property of CompoSecure and may be used without any obligation to pay referral or placement fees. Any agency or recruiter seeking to work with CompoSecure's Talent Acquisition Team should contact our team directly by sending an email to recruiting@composecure.com.

Job Description Who are we and why should you join us? ConcertAI is building the future of precision medicine. We use advanced artificial intelligence and real-world data to transform how healthcare and life sciences generate evidence, make decisions, and improve patient outcomes—starting in oncology and rapidly expanding across therapeutic areas. Our teams partner with the world's leading pharmaceutical companies, providers, and research organizations to solve some of healthcare's most complex challenges. At the core of our innovation is Cara, our next-generation AI platform that unlocks powerful insights from complex clinical, imaging, and molecular data. Combined with our Precision Suite—which unifies real-world data, advanced analytics, and scalable evidence generation—these solutions are transforming how clinical development, regulatory, and commercialization decisions are made. ConcertAI brings together a portfolio of purpose-built solutions, including TeraRecon, an industry leader in advanced imaging and AI-driven visualization, and CancerLinQ, the ASCO-originated oncology platform advancing care quality and large-scale discovery. Joining ConcertAI means working alongside bold thinkers, builders, and healthcare experts on innovative, high-impact products that directly improve patient lives. You'll be part of a fast-growing, mission-driven organization at the forefront of AI-enabled healthcare, with meaningful opportunities for growth and leadership. Your Opportunity We are seeking a visionary, AI-first, Product Leader to lead productization and GoToMarket (GTM) for our AI-driven Imaging Workflow Solutions. This role will own the product vision, strategy, commercialization, and product P&L metrics for an intelligent clinical pathways platform designed to improve patient outcomes while maximizing reimbursement performance. This is a builder and GTM role for a new productline within TeraRecon. You will define and develop an AI-first product that embeds clinical evidence, imaging workflow & process optimization, predictive imaging analytics, payer logic related to the entire care pathway, and documentation automation directly into clinical and operational workflows. You will operate with urgency and accountability — driving measurable clinical impact, accelerating prior authorization, reducing denials, and delivering sustainable revenue growth. This is a customer facing role based in the USA that will work with global software development and Quality/Regulatory teams — while partnering closely with Sales to win lighthouse customers and close the first wave of enterprise deals. How You'll Make an Impact Product Strategy, Product Management, & Market Leadership • Define and execute the long-term strategy for AI-driven clinical pathway and reimbursement solutions. Position TeraRecon as the market leader, develop differentiated value propositions, own pricing strategy, and drive ecosystem expansion. Ownership of Product P&L metrics • Own revenue growth, margins, and overall financial performance. Lead forecasting, investment planning, cost discipline, and executive KPI reporting while ensuring measurable customer ROI. AI-First, AI-Fast Product Execution • Deliver scalable, enterprise-grade AI solutions/technologies embedded within EHR workflows. Operationalize predictive models, integrate payer logic and coding guidance, and drive rapid innovation cycles. Commercial & Enterprise Growth • Partner with Sales to win lighthouse clients, support strategic deals, ensure successful implementations, and translate outcomes into repeatable go-to-market (GTM) momentum. Team Leadership • Lead and align the India-based software development, global AI development, and global Compliance teams with product priorities, ensuring operational excellence and seamless global collaboration. Cross-Functional Executive Leadership • Collaborate across Engineering, Data Science, Clinical, Revenue Cycle, and Regulatory teams to drive adoption, maintain compliance, and build a high-performing, AI-native organization. What You'll Bring Product & Commercial Leadership • 10+ years of leadership experience in healthcare product, clinical transformation, AI-driven solutions, or medical imaging. Proven Product management/ownership with demonstrated revenue growth. Experience launching, scaling, and commercializing enterprise healthcare or imaging solutions. Having a track record supporting or closing complex enterprise healthcare sales Clinical, Imaging & Reimbursement Expertise • 10+ years in medical imaging workflows, clinical care, or imaging management within U.S. healthcare providers., • 5+ years in clinical transformation, utilization review, imaging economics, or pathway development. Working knowledge of reimbursement models (FFS, DRG, bundled payments, value-based care). Has a strong understanding of payer requirements, coding practices, and prior authorization processes. Experience collaborating with revenue cycle, payer, or pre-authorization teams. Ability to connect clinical workflows with financial and operational performance Technology & Data Fluency • Experience leading AI-enabled, analytics-driven, or medical imaging software solutions. Familiarity with EHR integration (Epic, Cerner) and practice management systems. Has experience with workflow design and cross-functional implementation. Strong data analysis skills to track outcomes, trends, and reimbursement metrics Leadership Profile • Strategic, systems-oriented leader who understands both clinical and business dynamics. Builder mindset; comfortable operating in matrixed, cross-functional organizations. Detail-oriented and proactive in managing payer-policy complexities. Strong communicator with a passion for clinical and financial excellence. Action-oriented leader with a focus on measurable results Learn More About ConcertAI Our team at ConcertAI is dedicated to transforming healthcare decision-making through the application of RWE and AI to improve patient outcomes. We work in a fast-paced, dynamic, high-performing culture where diversity, collaboration, and innovation are valued. Join us on our quest to create a world free of disease. Learn more about ConcertAI at www.concertai.com , or follow us on LinkedIn. Serving 1,300 clinical sites globally, TeraRecon - a ConcertAI company - is a Best in KLAS solution provider for AI-empowered radiology, oncology, cardiology, neurology, and vascular surgery. In the future, the combination with ConcertAI could bring a single, advanced AI-augmented diagnosis and interpretation capability from clinical trials to patient care. EEO & ADA Statement ConcertAI provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. We are dedicated to providing reasonable accommodations throughout the application and hiring process, as well as during employment, in accordance with applicable federal, state, and local laws. Requests for accommodation will be handled confidentially and in accordance with applicable law.

Job DescriptionCompany Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. 2025, Eurofins generated total revenues of EUR € 7.296 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description Responsible for all activities in the microbiology laboratory, working closely with the Site Director, Microbiology staff, Quality Manager, Business Development and customers. Is a member of the Quality Committee and can act as a Business Unit Leader or Quality Manager in his/her absence. Ensures compliance of the testing within the microbiology laboratory with cGMP, ISO 17025 and company quality standards. Essential Duties/ Responsibilities: • Provides operational leadership and support through effective planning, execution, management of personnel and available resources. • Motivates staff to perform at high levels, and ensures engaged employees, satisfied clients, and efficient processes that are quality driven., • Assist the Business Unit Manager in managing daily operations of the microbiology laboratory including scheduling, supervising, instructing, monitoring, and assisting in the performance of manual and instrumental analyses. Develops and maintains production schedules, ensuring on-time completion and delivery of Reports and Data Packages into QA., • Is a subject matter expert for the business in their field. Provides and assists customers with understanding regulatory guidelines, test results, technical support, and the appropriateness of specific tests, including advantages and limitations of test procedures., • Accomplished productivity through effective communication of company goals/objectives and supports staff in achieving such expectations by appraising performance and giving continuous feedback. • Plans and oversees development of new laboratory technologies and test methods. • Ensures continuous development and training of staff., • Ensures that the facility, instrumentation, and equipment are well maintained and in good working order. • Ensures the implementation of the laboratory Quality Management System and its compliance with ISO/IEC 17025. • Handles client and employee requests and concerns appropriate and in a timely manner. • Performs laboratory testing, when necessary., • Evaluates resumes, interviews potential employees, and hires new personnel., • Assists in writing regulatory documents relating to the Quality Management System and regulatory agencies such as ISO, AAMI, USP, and FDA.Qualifications Education: • Bachelor’s degree in microbiology, or a related field. Experience: • Minimum of 2-3 years of experience in a testing laboratory, with a preference given to candidates with supervisory experience, • Good knowledge of quality systems such as ISO 17025 and cGMP., • Internal contact includes daily contact with all personnel and regular contact with management., • External contact may require infrequent contact with Clients., • External contact with vendors may be required., • Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude. Competencies: • Detailed understanding of microbiological sciences related to pharmaceutical and medical device testing., • Excellent verbal and written communication skills., • Excellent interpersonal and organizational skills., • Responsive problem solver and action-oriented Additional Information Positions are full-time, working (Monday-Friday 8am-5pm), overtime as needed. Candidates currently living within commutable distance to North Brunswick Township, NJ are encouraged to apply. Compensation: $95,000-105,000 depending on related experience and qualification. Excellent full time benefits including • Comprehensive medical coverage, dental, and vision options, • Life and disability insurance, • 401(k) with company match, • Paid vacation and holidays Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

Job Description Come join an exciting and innovative company that puts the “care” back in healthcare! At KabaFusion, our patients come from all walks of life and so do we. We hire GREAT people, period! Our culture celebrates and supports the differences that make us unique. Here, it doesn’t matter what your role is, your hard work and dedication is not only recognized but celebrated. Join us and find out why this is the place to excel and do your best work. About Us: What started as a single pharmacy in 2010 has grown into KabaFusion becoming the largest privately held home infusion company in the country. We have a national network of pharmacies and nursing offices strategically placed to service 40+ states. Couple that with over 30 years of combined experience and it’s no wonder why KabaFusion is the industry leader in home infusion. JOB SUMMARY: This position is responsible for supporting pharmacy operations by assisting pharmacists with prescription processing, sterile compounding, inventory management, quality assurance activities, and patient service functions in accordance with state and federal regulations, USP standards, and company policies. This role coordinates medication, supply, and equipment deliveries; maintains accurate patient, pharmacy, and quality records; and serves as a key point of contact for patients, caregivers, providers, and internal teams. The Pharmacy Technician also performs administrative and operational duties to ensure safe, efficient, and compliant delivery of home infusion pharmacy services. ESSENTIAL DUTIES AND RESPONSIBILITIES: 1. Support pharmacists in coordinating daily pharmacy operations and workflow to ensure efficient, safe, and timely delivery of pharmacy services., 2. Perform prescription processing, order entry, and related documentation activities under the supervision of a licensed pharmacist., 3. Prepare and compound sterile medications and pharmaceutical products in compliance with applicable laws, USP standards, accreditation requirements, and company policies., 4. Maintain clean room environments, pharmacy equipment, and infusion devices to support regulatory compliance and patient safety., 5. Conduct and document quality assurance and quality control activities, ensuring adherence to organizational and regulatory standards., 6. Manage pharmacy inventory, including ordering, receiving, stocking, and monitoring medications, supplies, and equipment., 7. Coordinate patient medication, supply, and equipment refills, deliveries, and related service logistics to support continuity of care., 8. Maintain accurate and complete patient, pharmacy, and operational records within electronic information management systems., 9. Provide professional customer service by communicating with patients, caregivers, healthcare providers, referral sources, and internal departments, escalating clinical concerns as appropriate., 10. Support reimbursement and administrative processes by verifying required authorizations, maintaining documentation, and assisting with pharmacy records management., 11. Generate, distribute, and maintain operational, quality, and management reports while participating in performance improvement initiatives., 12. Provide administrative and cross-functional support to pharmacy leadership and other departments while completing required training, competencies, and assigned projects., 13. Other related duties as assigned by manager or designee. JOB REQUIREMENTS AND QUALIFICATIONS Education: • High school diploma or equivalent required. Certifications or Licenses: • Current and unrestricted pharmacy technician licensure, certification or registration where required by state law. If required by state law: o Pharmacy Technician Certification (CPhT) through the Pharmacy Technician Certification Board (PTCB) is acceptable; or o Eligibility to obtain within six (6) months of hire; this includes training permit. • Completion of sterile compounding training and competency assessments as required by company policy and regulatory standards, if required by state law. Experience • Knowledge of basic drug terminology, pharmaceutical calculations, drug use and aseptic technique., • Previous sterile compounding experience in a home infusion, hospital, or specialty pharmacy setting., • Knowledge of USP <797> and USP <800> standards and practices., • Minimum one (1) year of pharmacy technician experience preferred; home infusion, sterile compounding, or specialty pharmacy experience preferred., • Knowledge of pharmacy operations, medication preparation, inventory management, and pharmacy documentation practices., • Working knowledge of applicable state and federal pharmacy regulations and quality standards, • Proficient with pharmacy management systems, electronic medical records, and Microsoft Office applications. What we offer: • Competitive compensation, • Benefits start on your 1st day of employment, • 401k w 4% match – no waiting or vesting period, • PTO / Floating Holidays / Paid Holidays, • Company paid life insurance, short term disability, • Employee Assistance programs to help with mental health / wellness, • Learning & Development Programs, • Perks… includes discounts on travel, cell phone, clothing and more…, • Generous employee referral program To learn more about KabaFusion, please visit our careers page: https://www.kabafusion.com/careers/

Job Description Job Description Date 06/2020 Location 1200 Airport Road, North Brunswick NJ Title Chemist, Quality Control 1, 2 & 3 Department Quality Control Reports to Manager, Analytical, R&D, & Method Validation FLSA (Exempt or Non-Exempt Non- Exempt Role Overview The Chemist, QC role is responsible for performing analytical testing, laboratory investigations, data review, and quality control activities to ensure the identity, strength, purity, and quality of raw materials, active pharmaceutical ingredients (APIs), in-process materials, finished products, and stability samples. The role operates within an FDA-regulated laboratory environment and supports compliance with cGMP, Good Documentation Practices, company procedures, and applicable regulatory requirements. The Chemist performs chemical and physical analysis using a variety of analytical techniques and laboratory instrumentation, including HPLC/UPLC, GC, ICP-MS, UV-Visible Spectrophotometer, FTIR, Auto Titrators, Dissolution Apparatus, Karl Fischer Titrators, Bulk Density Testing, Potentiometers, and other QC laboratory equipment. The role is responsible for accurate testing, documentation, instrument operation, troubleshooting, and communication of analytical results to support product quality and timely release. Throughout all levels, the Chemist is expected to demonstrate strong analytical skills, attention to detail, problem-solving ability, and commitment to quality and compliance. The career progression moves from executing established laboratory procedures at the entry level to independently managing complex analytical challenges, supporting method validation/verification, compendial compliance, and providing technical leadership within the QC organization. Areas of Responsibility Chemist, QC 1: The Chemist, QC I is an entry-level laboratory professional responsible for performing routine chemical and physical analysis of raw materials, in-process samples, finished products, and stability samples according to established official and in-house test procedures. The Chemist evaluates samples for identity, strength, purity, and quality attributes while developing proficiency in analytical techniques, laboratory instrumentation, and GMP laboratory practices. The Chemist, QC I works under the guidance of experienced chemists and supervisors to ensure testing is performed accurately, safely, and in compliance with company procedures, cGMP, and regulatory requirements. Key Responsibilities • Perform routine sampling, chemical testing, physical testing, and assays of raw materials, active pharmaceutical ingredients (APIs), in-process materials, finished products, and stability samples in an FDA-regulated laboratory environment., • Perform analytical testing using wet chemistry techniques and laboratory instrumentation, including:, • HPLC/UPLC, • GC, • IR/FTIR, • UV-Visible Spectrophotometer, • Auto Titrator, • Dissolution Apparatus, • Karl Fischer (KF), • Potentiometer, • Bulk Density testing, • Prepare reagents, standards, solutions, and samples according to approved procedures., • Perform assigned testing activities and accurately document analytical results., • Support troubleshooting and testing of specific batches to assist with identification of potential causes of out-of-specification (OOS) results., • Assist with customer complaint investigations by providing analytical test results., • Prepare and review QC documentation, including test records, SOPs, test procedures, and protocols as assigned., • Perform routine instrument maintenance and calibration activities under supervision and training., • Maintain laboratory organization, housekeeping, safety, and chemical waste compliance., • Follow cGMP, Good Documentation Practices, and company quality requirements., • Complete approximately:, • 95% analytical testing activities, • 5% documentation and record review activities., • Work extended hours or occasional weekends as required., • Perform other duties as assigned. Chemist, QC 2: The Chemist, QC II is an experienced laboratory professional responsible for performing routine and complex analytical testing with increased independence. This role applies technical knowledge to troubleshoot analytical issues, support investigations, review data, maintain laboratory equipment, and provide technical support to QC operations. Chemist, QC II demonstrates proficiency with analytical instrumentation and applies knowledge of cGMP, and laboratory procedures to ensure accurate and timely testing. Key Responsibilities Includes all Chemist, QC I responsibilities, with increased ownership and accountability: • Independently perform chemical, physical, and instrumental testing of raw materials, APIs, in-process materials, finished products, and stability samples., • Perform complex analytical testing using QC instrumentation including:, • HPLC/UPLC, • GC, • IR/FTIR, • UV-Visible Spectrophotometer, • Dissolution, • Karl Fischer, • Auto Titrator, • Potentiometer, • Other QC laboratory equipment., • Troubleshoot analytical testing issues and instrument-related challenges., • Support investigations related to:, • Out-of-specification (OOS) results, • Atypical results, • Customer complaints, • Product quality concerns, • Analyze test results and provide technical input to assist with root cause determination and corrective actions., • Review analytical data and QC documentation for accuracy and completeness., • Prepare and revise SOPs, test procedures, protocols, and laboratory documentation., • Perform instrument maintenance, calibration, and troubleshooting activities with limited supervision., • Support continuous improvement activities within the QC laboratory., • Provide technical support and guidance to QC Chemist I personnel., • Ensure compliance with customer specifications, company requirements, and federal, state, and local regulations., • Maintain laboratory safety, compliance, and documentation standards., • Work extended hours or weekends as needed. Chemist, QC III : The Chemist, QC III is a senior-level technical contributor responsible for both routine and advanced analytical testing, complex troubleshooting, laboratory investigations, and technical leadership within the QC organization. This role serves as a subject matter expert for analytical methods, instrumentation, and laboratory practices while supporting compliance, continuous improvement, and cross-functional initiatives. Key Responsibilities Includes all Chemist, QC II responsibilities, with increased technical leadership: • Serve as a technical resource for analytical testing, instrumentation, and laboratory troubleshooting., • Perform and oversee complex analytical testing activities for raw materials, APIs, in-process materials, finished products, and stability samples., • Lead troubleshooting activities for specific batches and analytical issues to determine root cause and recommend corrective actions., • Lead or support complex investigations related to:, • OOS results, • Deviations, • Customer complaints, • Product quality issues., • Review and provide technical approval of analytical data and laboratory documentation., • Support analytical method validation, verification, transfer, and optimization activities., • Develop, review, and improve SOPs, test procedures, protocols, and technical reports., • Provide technical guidance and mentoring to QC Chemist I and QC Chemist II team members., • Support internal audits, customer audits, and regulatory inspections.

Job DescriptionDescription: Who We Are RK Pharma is a growing pharmaceutical organization focused on developing and manufacturing high-quality, affordable drug products through disciplined execution and strong internal collaboration. We operate in regulated environments where financial accuracy, cost control, and thoughtful decision-making directly support quality and long-term sustainability. We are a practical, hands-on organization. We value leaders who understand the details, roll up their sleeves, and build systems that work — not just presentations that look good. About the Role The Chief Financial Officer (CFO) is a key leadership role responsible for overseeing RK Pharma’s financial operations, strategy, and controls. This position partners closely with senior leadership to ensure the company remains financially disciplined, operationally efficient, and positioned for steady growth. This role is intentionally suited for someone who may be stepping into the CFO seat for the first time — for example, a Controller or senior finance leader with strong pharmaceutical experience who is ready to expand scope and influence. This is not a purely strategic or advisory role. The CFO at RK Pharma is expected to be hands-on, deeply familiar with the numbers, and comfortable working in a scrappy, growing environment where systems continue to mature. Key Responsibilities • Own and manage all financial operations including accounting, budgeting, forecasting, and reporting, • Oversee cost accounting, inventory valuation, and margin analysis within a pharmaceutical manufacturing environment, • Ensure accurate financial close processes and strong internal controls, • Support pricing, product costing, and financial decision-making tied to manufacturing operations, • Partner with Operations, Quality, and Supply Chain to support data-driven decisions, • Lead cash flow management, working capital planning, and financial risk management, • Support audits, compliance requirements, and financial reporting obligations, • Develop and improve financial systems, processes, and controls as the organization grows, • Provide clear, practical financial insight to executive leadership, • Build and mentor the finance team as appropriate What We’re Looking For Required • Bachelor’s degree in Finance, Accounting, or a related field, • Significant experience in pharmaceutical, biotechnology, or regulated manufacturing environments, • Strong background in cost accounting and manufacturing finance, • Experience leading accounting or finance functions (for example, Controller or Senior Finance Manager), • Comfort working in smaller or growing organizations, • Hands-on leadership style with strong attention to detail, • Ability to translate financial data into practical business decision, presentations for M&A, and PE boards. Preferred • CPA or equivalent professional certification, • Experience supporting GMP manufacturing operations, • Prior experience working closely with Quality, Operations, or Supply Chain teams, • First-time CFO candidates with the right background are strongly encouraged to apply IMPORTANT CONTEXT (PLEASE READ) RK Pharma is a growing, resource-conscious organization. This role is best suited for someone who values building and improving systems rather than inheriting perfect ones, being close to the work and the numbers, a collaborative and no-ego leadership culture, and stability and long-term impact over short-term polish. This role may not be the right fit for someone seeking a highly resourced finance organization or a purely strategic, solely investor-facing CFO role. How We Work At RK Pharma, quality comes before speed. We value clear communication, disciplined execution, and leaders who stay grounded in the details while keeping an eye on the bigger picture. The CFO is expected to model calm, practical leadership and support sound decision-making across the organization. What We Offer • A meaningful leadership role with real impact on company direction, • The opportunity to step into the CFO seat and grow with the organization, • A collaborative, respectful working environment, • Competitive compensation aligned with scope and experience Equal Opportunity Employer RK Pharma is an equal opportunity employer committed to fair, consistent, and respectful hiring practices. Requirements:

Job DescriptionCompany Description Vantage provides natural solutions to our customers’ technical performance and marketing needs through a unique combination of chemistry, application expertise and service. Underpinned by our broad portfolio of formulations, ingredients and actives that are built on a backbone of sustainable oils, fats and their derivatives, Vantage targets selected markets and applications including personal care, food, surface treatment, agriculture, pharma, and consumer and industrial performance. Vantage is headquartered in Deerfield, IL., operates in 11 countries worldwide and employs more than 1,000 talented professionals focused on delivering exceptional customer experiences with every interaction. We are a dynamic people-centered organization where you’ll be part of a collaborative global team. Embracing our cultural diversity, we learn from each other to constantly improve, adapt and iterate. We value the voices and talents of our colleagues, empowering them to drive their unique ideas to completion. We’re convinced that exceptionally motivated employees produce outstanding results, and we celebrate them by fostering a culture of recognition, development, learning, excellence and shared achievement. Most importantly, we know you’re going to like it here. For more information visit: vantagegrp.com or LinkedIn/vantage. Job Description The role: The Product Stewardship Customer Assurance Manager (PSCA) leads Vantage’s global customer response operation for product stewardship inquiries, overseeing the end-to-end CRM caseload and ensuring customer requests are prioritized, coordinated, and resolved with timely, accurate, and compliant responses. The role leads the PSCA team and coordinates cross-functional support across Regulatory, Quality, Technical Service, Product Stewardship, R&D, Commercial, and Supply Chain, with a strong focus on customer satisfaction, service levels, operational efficiency, and continuous process improvement. Position Scope This is a global manager-level role responsible for leading the Product Stewardship Customer Assurance function and managing the end-to-end customer response operation for product stewardship-related inquiries. The role includes direct team leadership, CRM caseload oversight, cross-functional response coordination, stakeholder engagement, performance tracking, and continuous improvement of customer assurance processes across regions. Customer Response Operations Lead the global Product Stewardship Customer Assurance (PSCA) function for customer inquiries related to regulatory, quality, technical, product safety, and compliance matters. Own the end-to-end customer response process, ensuring inquiries are efficiently routed, managed, and resolved from receipt through closure. Ensure customers receive accurate, complete, and timely responses that meet defined service levels, expectations, and follow-up needs. Serve as the escalation point for complex or urgent inquiries while driving a customer-centric operating model focused on responsiveness, accountability, and service excellence. CRM Caseload Management Own the global CRM caseload for PSCA inquiries, ensuring cases are prioritized, assigned, tracked, and closed effectively. Balance team workload to ensure efficient case progression, coverage, and achievement of response targets. Monitor volumes, aging, response times, backlog, and service levels to ensure performance objectives are met. Maintain CRM discipline, controls, and visibility into case status, priorities, workload distribution, timelines, documentation, and closure. Cross-Functional Response Coordination Coordinate integrated customer responses by engaging subject matter experts across Regulatory, Product Stewardship, Technical Service, Quality, R&D, Commercial, Supply Chain, and other functions. Drive timely information gathering, stakeholder alignment, and consistent responses that meet customer commitments. Serve as the central coordination point between internal experts and customer-facing teams, removing barriers and ensuring follow-up through completion. Team Leadership Lead, coach, and develop PSCA specialists responsible for customer inquiry management and documentation support. Set team priorities, performance expectations, service standards, and capability-building plans. Build a culture of ownership, responsiveness, collaboration, customer focus, and effective cross-functional coordination. Performance Management & Continuous Improvement Establish and monitor KPIs for response and resolution times, SLA attainment, backlog, customer satisfaction, and case quality. Analyze trends to improve responsiveness, workflow efficiency, resource utilization, and customer experience. Lead initiatives to streamline processes, standardize responses, and scale service delivery. Maintain dashboards and reporting that provide visibility into operational effectiveness and customer service outcomes. Stakeholder Engagement Partner with Commercial, Regulatory, Quality, Product Stewardship, R&D, and other functions to align priorities and improve customer support processes. Represent the voice of the customer by identifying recurring inquiry trends and opportunities to improve processes, documentation, and service delivery. Support strategic initiatives that enhance customer experience, operational scalability, and performance. Success Measures Achievement of CRM response and resolution SLAs, with reduced backlog and case aging. Improved customer satisfaction, responsiveness, and response quality. Effective coordination and closure of cross-functional inquiries. Operational efficiency, productivity, team engagement, and performance against service goals. Education: Bachelor’s degree in biology, Chemistry, Environmental Science, Pharmaceutical Science, or a related technical discipline. Experience: • Eight (8) or more years of experience in product stewardship, regulatory affairs, quality, R&D, technical service, or related functions., • Two (2) or more years of people leadership in a customer-facing technical or compliance environment., • Experience in chemical, specialty ingredients, consumer products, life sciences, or related industries., • Demonstrated experience managing customer inquiries through CRM systems and service management processes. Knowledge, Skills, & Talents Strong understanding of customer documentation requirements related to product stewardship, regulatory compliance, and quality management system obligations. Proficiency with CRM platforms, reporting tools, and KPI management; experience with MS Dynamics 365 and Power BI strongly preferred. Familiarity with global regulatory frameworks, third-party certifications, and evolving customer compliance expectations. Proven ability to lead, coach, and develop teams while managing priorities, projects, and organizational needs as an individual contributor. Strong customer service mindset with excellent problem-solving, verbal, and written communication skills. Ability to influence stakeholders, foster collaboration, and drive alignment across functions and regions. Working Conditions Office-based role with regular use of CRM platforms, reporting tools, and standard business applications. The role requires frequent collaboration across global and regional stakeholders and may require flexibility to support urgent customer inquiries, escalations, and business priorities across time zones. Pay and Benefits The estimated base pay range for this position is: 133,000 - $199,000 annually. Actual pay will be determined based on education, certifications, experience, qualifications, skills and geographic location. This position is eligible to participate in a short-term incentive program. Vantage offers a comprehensive benefits package to eligible employees, including: Medical, HSA, dental, vision FSA (limited purpose, dependent care, and commuter/parking) Life and AD&D insurance Accident, hospital indemnity and critical illness insurance Short- and long-term disability EAP, identity theft protection Paid time off, Parental Leave 401(k) with company match Additional Information All your information will be kept confidential according to EEO guidelines.

Job Description Job Summary The Director, Healthcare Compliance is responsible for leading and operating the Company's healthcare compliance program and promoting a culture of ethics, integrity, and compliance across the organization. Reporting to the Chief Legal Officer & Chief Compliance Officer, this position serves as the Company's primary healthcare compliance leader and strategic advisor to Commercial, Medical Affairs, Market Access, Patient Services, Regulatory Affairs, and other business functions. The Director is responsible for designing, implementing, monitoring, and continuously improving an effective healthcare compliance program consistent with OIG Compliance Program Guidance, applicable federal and state healthcare laws, FDA regulations, industry codes, and Company policies. This is a highly visible, hands-on leadership role responsible for executing key aspects of the compliance program, including risk assessment, training, monitoring, investigations, transparency reporting, and compliance governance. The Director will partner closely with business leaders across the organization and may oversee compliance personnel and external resources as the function evolves. The Director will work closely with the Associate General Counsel on healthcare regulatory matters, investigations, policy development, compliance monitoring activities, and legal-compliance risk assessments. Core Responsibilities Program Leadership • Lead all aspects of the healthcare compliance program., • Develop and execute annual healthcare compliance strategy and work plan., • Conduct enterprise healthcare compliance risk assessments., • Maintain compliance policies, standards, procedures, and controls., • Develop compliance metrics and key performance indicators. Compliance Governance • Administer Healthcare Compliance Committee activities., • Prepare reports for Executive Leadership, Compliance Committee, and Board committees., • Escalate significant compliance risks and investigations., • Serve as the primary compliance advisor to the Chief Compliance Officer and provide regular updates regarding compliance program effectiveness, emerging risks, investigations, and remediation activities. Commercial and Medical Compliance • Serve as a core member of the MLR review process., • Advise on promotional materials and promotional claims., • Support launch and lifecycle compliance activities., • Provide guidance regarding speaker programs, advisory boards, consultants, grants, charitable contributions, sponsorships, and other healthcare professional engagement activities. HCP/HCO Interactions Provide oversight of: • Anti-Kickback Statute compliance, • False Claims Act risk mitigation, • Sunshine/Open Payments reporting, • State transparency laws, • Fair Market Value (FMV) assessments, • Needs assessments, • Engagement documentation and controls Monitoring and Auditing • Develop annual monitoring plan., • Conduct and oversee monitoring reviews., • Recommend and track corrective action plans., • Analyze trends and emerging compliance risks. Investigations • Lead healthcare compliance investigations., • Partner with Human Resources and Legal, when appropriate., • Ensure appropriate documentation, remediation, and CAPAs. Training and Communications • Create risk-based compliance training programs., • Deliver live training to commercial, medical, and cross-functional teams., • Maintain compliance communications and awareness initiatives. Compliance Leadership & Execution • Serve as a hands-on compliance leader responsible for both strategy development and program execution., • Personally conduct and oversee key compliance activities, including risk assessments, monitoring, investigations, training, and governance reporting., • Influence and lead cross-functional stakeholders without direct reporting authority., • Coordinate external advisors and consultants to support specialized compliance initiatives., • Build and scale the healthcare compliance function and team as business needs evolve. Qualifications • Bachelor's degree required., • JD, MBA, PharmD, MSN, or equivalent advanced degree preferred., • 10+ years of pharmaceutical, biotechnology, healthcare, or healthcare compliance experience., • 5+ years leading healthcare compliance programs, initiatives, or teams in a pharmaceutical, biotechnology, or healthcare organization., • Deep expertise in: o FDA promotional regulations o Anti-Kickback Statute o False Claims Act o Sunshine/Open Payments o OIG Compliance Program Guidance o PhRMA Code o State healthcare compliance requirements • Experience leading audits, investigations, training, monitoring, and compliance risk management programs., • Significant MLR review experience., • Demonstrated ability to independently build, implement, and operate healthcare compliance programs in a pharmaceutical, biotechnology, or healthcare environment., • Strong business partnering, communication, and influencing skills with demonstrated ability to engage effectively with executive leadership and cross-functional stakeholders., • Proven ability to manage multiple priorities in a dynamic growth environment. Reporting Relationship • Solid-Line Reporting: Chief Legal Officer & Chief Compliance Officer, • Dotted-Line Reporting: Vice President, Associate General Counsel, • Key Internal Partners: Legal, Commercial, Medical Affairs, Market Access, Regulatory Affairs, Finance, Human Resources, Quality, Patient Services, and Executive Leadership, • Direct Reports: None initially; future compliance personnel may be added as the compliance function evolves. Position Profile This role is designed to be the Company's senior healthcare compliance leader and primary compliance subject matter expert. The position combines strategic oversight with direct operational responsibility and requires a professional who can independently build, implement, monitor, and continuously improve an effective healthcare compliance program. Success in the role will depend on sound judgment, strong cross-functional influence, deep healthcare compliance expertise, and a willingness to operate as a hands-on leader while helping scale the compliance function as the organization grows. The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary. As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

The Document Control Assistant is responsible for administering the processes and practices which support documentation compliance. The Specialist will work in a pharmaceutical production facility and in close collaboration with Quality Assurance, Qu Control, 2nd Shift, Assistant, Manufacturing, Systems

Job Description Job Description Date 10/2025 Location 1300 Airport Road, North Brunswick NJ Title Mechanic, Maintenance (PKG.) Department Facilities / Engineering Reports to Manager, Maintenance FLSA (Exempt or Non-Exempt) Non -Exempt Role Overview The Packaging Mechanic is responsible for operating, maintaining, troubleshooting, and repairing packaging lines and auxiliary equipment (e.g. fillers, cappers, labelers, cartoners, sealers, conveyors, etc.). On higher levels, the role involves preventive maintenance, changeovers, and acting as a technical leader on the packaging floor. Areas of Responsibility Level 1 – Mechanic, Maintenance (PKG.) Mechanic supports routine maintenance, equipment cleaning, basic setup, basic troubleshooting, and minor repairs under supervision. Ideal for those newer to packaging maintenance, this role focuses on learning and executing tasks safely and accurately. Operates under close supervision, handling routine maintenance tasks such as cleaning, basic setups, and minor repairs. Escalates complex issues to higher-level technicians. Key Responsibilities: • Assist with setup, changeovers, cleaning, and basic operation of packaging lines., • Load materials (labels, cartons, films) into packaging equipment., • Perform basic visual inspections, detect packaging defects, and remove faulty units., • Assist in daily cleaning, line sanitation, and housekeeping., • Follow standard operating procedures (SOPs), batch records, and safety protocols., • Document basic packaging metrics, logs, and shift records., • Escalate technical issues to higher‑level technicians., • Assist in minor mechanical adjustments (e.g. tightening bolts, replacing belts) under supervision., • Participate in safety and quality training. Level 2 – Mechanic, Maintenance (PKG.) Mechanic requires the ability to independently perform equipment maintenance, moderate troubleshooting, perform machine change overs and setup and perform limited repairs . Employees at this level work with moderate supervision, frequently exercising independent judgment. They apply solid mechanical and electrical skills to set up, repair, troubleshoot, and maintain equipment. They are expected to analyze problems, propose solutions, and take ownership of more complex tasks. Key Responsibilities: • Independently perform maintenance, troubleshooting, and repair on packaging lines including blister, bottle, cartoning, and label printing systems., • Diagnose mechanical, electrical, pneumatic, and control system issues (motors, drives, sensors, solenoids, PLC I/O) on packaging equipment., • Execute changeovers and line reconfigurations, calibrations, and adjustments for product format changes., • Perform preventive maintenance and predictive maintenance tasks, identifying worn parts and scheduling replacements., • Read and interpret mechanical drawings, electrical schematics, and wiring diagrams., • Mentor Level 1 technicians, guiding and reviewing their work., • Assist in packaging reliability improvement initiatives, root cause analyses, and process optimization., • Support emergency breakdowns and unscheduled repairs to minimize downtime., • Participate in regulatory and safety audits related to packaging lines. Level 3 - Mechanic, Maintenance (PKG.) Mechanics are highly skilled professionals who lead complex repairs, system diagnostics, and project-based maintenance work. They serve as subject matter experts and may act as a shift lead. Operates independently with full responsibility over packaging line performance. Handles advanced diagnostics, major repairs, preventive maintenance programs. Makes judgment calls on repair vs replace. Leads projects, supports regulatory compliance, and provides technical leadership. Works with the engineerign team in identfying and proposing process improvements and in maintaining adequate critical spare parts as well as consumables. Key Responsibilities: • Lead maintenance, upgrade, and optimization of complex packaging lines (blister, bottle, cartooning, label printing, IFC lines)., • Perform advanced diagnostics, root cause analysis, and system redesigns to improve reliability and throughput., • Take full responsibility for major line failures and coordinate cross‑functional resources to resolve issues., • Plan and execute capital projects, line changeovers, expansions, and line integrations., • Act as technical liaison with vendors, OEMs, contractors, and internal engineering groups., • Develop and manage preventive and predictive maintenance programs., • Mentor, train, and coach Level 1 and Level 2 technicians., • Participate in regulatory inspections and ensure compliance documentation., • Recommend equipment upgrades, modifications, or replacements., • Lead packaging continuous improvement initiatives (OEE improvements, downtime reduction). Requirements Education & Qualification: Level 1 – Mechanic, Maintenance (PKG.) • High School diploma or GED required., • 0–2 years in maintenance experience in a manufacturing environment, • Basic mechanical aptitude and tool familiarity., • Ability to follow written SOPs and safety protocols., • Willingness to work flexible shifts and overtime., • Forklift experience is a plus. Level 2 – Mechanic, Maintenance (PKG.) • High school graduate or GED equivalent, Technical or vocational training is a plus., • 3+ years of hands-on maintenance experience in manufacturing., • Strong understanding of safety, compliance, and regulatory standards., • Knowledge of cGMP, OSHA, and equipment schematics., • 1+ Years work experience in a regulated industry such as Nutritional’s, vitamins, food manufacturing or pharmaceutical equipment maintenance is preferred. Level 3 – Mechanic, Maintenance (PKG.) • Must have a high school diploma or GED equivalent, • Associate degree, technical certification, or vocational training is a plus, • 5+ Years work experience in a regulated industry such as Nutritional’s, vitamins, food manufacturing or pharmaceutical equipment maintenance is preferred., • Advanced understanding of mechanical, pneumatic, and electrical systems., • PLC troubleshooting experience preferred., • Strong leadership and communication skills., • Ability to work independently with little to no supervision., • Trade certifications in HVAC, electrical, pneumatics, or hydraulics are highly preferred. Certifications, Licenses, Credentials: • License or certifications in electronics, pneumatics and/or hydraulics preferred., • Forklift /scissor lift driver’s certification is a plus but not a requirement. Skills & Ability • HVAC, Electrical, Plumbing, Painting, pneumatic, boilers, compressed air systems, pumps, hydraulic and Mechanical systems as required. PLC is a plus., • General PC proficiency and work order systems etc., • Skill in handling several projects or tasks at the same time, or within a given time frame., • The ability to recognize a safety issue or potential safety issue., • Skill in quality and compliance vigilance., • Ability to maintain a professional, positive attitude at all times., • Ability to communicate with coworkers, management team members, and other individuals in a courteous and professional manner., • Demonstrates ability to work in a team and assist others., • Able to follow written instructions precisely and perform basic math calculations as required., • Understands and is knowledgeable of cGMP, OSHA standards, etc., • Demonstrates the ability to read and write basic English to be able to understand the industry-regulated instruction sheets., • Demonstrates forklift experience with both sit-down and stand-up trucks., • Demonstrates the ability to read and write basic English to be able to understand the industry regulated instruction sheets., • Mechanically inclined to understand inner workings of equipment., • Able to read from schematics and blueprints. Physical Requirements (lifting, etc.): • Ability to lift up to 50 lbs.; occasionally lift and move up to 75 pounds., • Must stand and walk on the production floor for a minimum of 6 hours per shift., • Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from the waist, or squatting, walking short distances., • Occasionally works from a rolling ladder or step stool, must be to lean over equipment as well as kneeling on t

Date - 06/2025 - Location - 1300 Airport Road Van Dyke Reports to - Manager, Warehouse - FLSA (Exempt or Non-Exempt) - Non-Exempt Role Overview The Forklift driver will perform all functions related to receipt of goods, put-away into warehouse, replenishment of pick areas, manual order processing, order auditing, shipment preparation, pallet building, truck loading and cycle counting inventory. All functions may require use of powered industrial trucks, SAP or RF as needed. Areas of Responsibility Receives product from domestic and overseas vendors, transfers, customer returns, refused shipments, and non-inventory support products. Accurately audits and verifies all incoming quantities for entry into computerized inventory. Performs on and off-site warehousing duties to include: the initial movement of materials to appropriate locations, effective space utilization, and material retrieval delivery, using powered industrial equipment as needed. Performs order fulfillment duties to include: reviewing and prioritizing available orders, determining stock requirements and maintaining levels of required inventory, physically picking and packing orders, auditing and verifying picked orders, preparing completed orders for shipping, using SAP and RF as needed. Performs shipping duties to include: Locating pallets to the dock, performing dock audits, verifying driver information, loading shipments on to trucks, properly filling out and signing BOL, tracking shipments, using SAP and RF as needed. Ensures safety and quality standards are consistently followed. Performs sortation duties to include: lifting cartons at sortation, palletizing cartons, printing pallet tickets, moving freight to the dock, using SAP and RF as needed. Ensures full compliance with Company policies, procedures, GMP's, Ethical Business Practice, and SOP's at all times. Ensures documentation such as operation logs, batch records, etc. are fully completed, signed and in compliance with company standards and regulatory requirements. Handles start up and shut down duties pertaining to equipment at the beginning and end of each shift. Maintains proper gowning and hygiene to ensure integrity of the product as per company policies. Works extended hours and occasional weekend overtime. Works in a safe and responsible manner in order to create an injury-free and incident-free workplace. Complies with all job-related safety and other training requirements. Other duties as assigned Requirements Education & Qualification: High school graduate or GED equivalent 2+ years in distribution/warehousing Minimum of one (2) year work experience in nutritional's, supplements, food or pharmaceutical manufacturing industries Valid driver's license Certifications, Licenses, Credentials: N/A Skills & Ability Demonstrates ability to work in a team and assist others. Able to follow written instructions precisely and perform basic math calculations as required. Understands and is knowledgeable of cGMP, OSHA standards etc. Mechanically inclined to understand inner workings of equipment. Demonstrates the ability to read and write basic English in order to be able to understand the industry regulated instruction sheets. Prior experience driving sit-down and stand-up PITs and ticketing experience helpful Must pass forklift certification process (both written and driving tests) Physical Requirements (lifting, etc.): Ability to lift up to 50 lbs.; occasionally lift and move up to 75 pounds. Must stand and walk on production floor a minimum of 6 hours per shift Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from waist, or squatting, walking short distances. Occasionally works from a rolling ladder or step stool, must be able to lean over equipment as well as kneeling on the floor to clean under the equipment. Must be able wear all PPE including lab coat, face mask, booties, gloves, safety glasses/goggles and respirators. Work is regularly performed inside a manufacturing environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employee can be exposed daily to chemicals and cleaning agents. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship. USPL is proud to be an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law. Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment. 2nd shift - 3.00 PM to 11:15 PM

The document control specialist is responsible for administering the processes and practices which support documentation compliance. The Specialist will work in a pharmaceutical production facility and in close collaboration with Quality Assurance, Quality Control and Production with a key-focus on documentation accuracy, quality and integrity. This is a 2nd shift role: Monday to Friday - 3:00pm to 11:30pm Essential Functions: • Manage document control processes thru electronic systems and/ or paper base systems. Distribute approved documentation to appropriate personnel, track receipt of documentation and notebooks., • Maintaining lists and postings required for both electronic and hard copy; maintain specific databases in Document Control Department and training records., • Perform data entry and management in systems (Document Compliance and Process Compliance) and maintain the print/soft copies for all documents., • Collaborate with teams to complete, maintain an up-to-date Document Control Systems., • Store, archive, and retrieve the version documents such as certificate of analysis of materials and products, specifications, methods, protocols, and report files., • Prepare and distribute PBRs, Packaging Batch Records, SOPs, methods and protocols, and other controlled documents., • Distribute approved documentation to appropriate personnel, track receipt of documentation and notebooks. Track document approvals and any related activities and ensure on-line documents are updated and accurate., • Work with other departments to clarify and correct documentation to ensure compliance., • Organize and maintain the work area and keep up-to-date files Additional Responsibilities: • Prepare documentation for third party inspection/audits., • Assist validation and regulatory department for documentation and for their various requirements. Education: • High School or GED - Required, • Associate degree - Preferred Experience: • Less than one year in manufacturing Specialized Knowledge: • cGMP, Computer Skills (MS Word, Excel, Access) The hourly rate for this position ranges from $20.00 to $25.00 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities. • Change Control, • Data Entry, • Detail Oriented, • Document Management Systems, • Organizational Skills, • Writing Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at accommodations@amneal.com. Requests will be handled confidentially and in accordance with applicable laws. • Job Identification 8966, • Job Category Document Control

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease. At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging. Job Description Summary: The Associate Manager, North America Commercial & Medical Affairs Finance is a Finance Business Partner to the North America Commercial & Medical Affairs organization. This individual collaborates closely with a range of cross-functional stakeholders including North America commercial stakeholders, other G&A functions, and other members of the finance and accounting functions. Key deliverables for this role are forecasts, budgets, monthly accruals & business commentary, as well as financial strategy. The incumbent works cross-functionally on Financial Planning and Analysis related issues. S/He also works closely with the corporate accounting organization to ensure proper expense recognition and compliance with internal controls. The Associate Manager, North America Commercial & Medical Affairs Finance ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. Job Description: Responsibilities: • Builds and maintains strong working relationships with commercial & Medical Affairs stakeholders, and finance management. Acts as a trusted business partner for North America colleagues, particularly on finance matters., • Serves as one point of contact for business partners on all Finance & Accounting topics., • Leads annual OPEX budget preparation and provides periodic forecast updates by partnering with relevant areas in the organization., • Creates and analyzes monthly, quarterly, and annual variance analysis reports and dashboards, focusing on key drivers and helping to articulate the'story' behind the numbers., • Maintains close communication with budget owners to ensure timely understanding of risk factors and opportunities that may impact forecasts., • Supports the monthly closing process, which may include preparing journal entries for accruals and reclassifications., • Prepares applicable management reporting, KPI and audit schedules as necessary., • Provides an accurate understanding of financial results, working with the broader finance team to ensure the correct accounting treatment is applied., • Maintains standard reporting tools to help identify key risks and opportunities., • Supports financial and business controls and standards including SOX requirements., • Supports special projects and ad-hoc financial analysis as necessary. Qualifications: Bachelor's degree in Finance or Accounting discipline and a minimum of 5 years relevant financial planning and analysis experience within a pharmaceutical, biotechnology or related environment OR equivalent combination of experience and/or education. • Demonstrated ability to think strategically and contribute business input to an established group of cross-functional professionals., • Demonstrated accounting and financial reporting experience., • Demonstrated understanding of, and experience performing financial modeling, forecasting, and budget related activities., • Committed to the timeline-driven process associated with reporting, annual budget, forecasts, and other ad hoc projects., • Demonstrated self-starter with strong attention to detail., • Demonstrated hands-on success executing month-end closing activities., • Proficiency with Microsoft Office, specifically possessing excellent comfort with Microsoft Excel and PowerPoint., • Excellent verbal and written communication skills, and comfort having a voice in larger team meetings., • Desire to learn about the business to partner with stakeholders more effectively., • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members., • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines., • Willingness to leverage company specific AI platform to find efficiencies, • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. Special knowledge or skills and/or licenses or certificates preferred: Experience with SAP, Hyperion, Power BI, generative AI models Travel requirements: 2% - 10% Expected Base Salary Range: $96,000 $115,000. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity. In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans. EEO Statement: PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

This role is responsible for the set-up, adjustment, maintenance, and troubleshooting of line equipment in compliance with Good Manufacturing Practices (GMP) and regulatory standards. The Set-Up Mechanic will play a key role in ensuring efficient, safe, and high-quality operations. Essential Functions: • Set up, adjust, and operate manufacturing line machines according to product batch records., • Conduct routine mechanical inspections and perform preventive maintenance to minimize downtime., • Provide emergency or unscheduled repairs on production and/or line equipment., • Perform changeovers between different products or formats efficiently to minimize downtime., • Perform track and trace activities as required on packaging equipment., • Maintain Lockout & Tagout system. Maintain accurate logs and documentation for all setups, maintenance, adjustments, and downtime., • Ensure the cleanliness and proper functioning of manufacturing equipment and room equipment., • Assist other maintenance staff in completing special projects or maintenance work as needed. Ensure compliance with SOPs, safety procedures, and current Good Manufacturing Practices (cGMP). Additional Responsibilities: • Other duties as assigned Qualifications: Education: • High School or GED - Required Experience: • 2 years or more in Manufacturing, pharmaceutical, maintenance repair Skills: • Attention to detail. - Intermediate, • Ability to read, write, and communicate in English at a level to facilitate the understanding terminology of the job. - Intermediate, • Ability to comprehend and follow written and verbal procedures or instructions - Intermediate, • Reading comprehension - Intermediate, • Good troubleshooting - Intermediate, • Able to use/operate a variety of hand tools, power tools, testers, and material handling equipment to perform job efficiently. - Intermediate The hourly rate for this position ranges from $26.00 - $35.00 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities. Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at accommodations@amneal.com. Requests will be handled confidentially and in accordance with applicable laws. Job Info: • Job Identification 8336, • Job Category Manufacturing Process Operations, • Posting Date 07/31/2026, 02:02 PM, • Locations 1 New England Avenue, Piscataway, NJ, 08854, US, • Job Schedule Full time

Job Description Cryopak is an innovative, cold chain & temperature-controlled packaging solutions manufacturer, for pharmaceutical, life science, biotech, food, and electronic companies. Cryopak helps to maintain the integrity of our customer’s products through the design, testing and manufacturing of packaging and materials for shipping cold chain products. We also provide the hardware and software for temperature verification along the distribution process. HOW YOU WILL CONTRIBUTE (Overview & Key Responsibilities): As a Production Team Lead you will be responsible for the proper conduct of the entire team on their shift. The Production Team Lead must achieve the set targets and ensure value-added production by maximizing the yield. The employee will be tasked to review, comment on and propose solutions for optimal performance ratios. Ensure compliance with health and safety on their shift. They may be called upon to collaborate with other departments depending on production and management needs. • The Production Team Lead will ensure that all operations are carried out correctly; enter production in the system and print production sheets., • Ensure that production personnel have all materials and equipment necessary to start their work according to production schedules., • Implement, train and deliver the standard operating procedures established for each workstation. Ensure the proper training and the correct filling of the production sheets, • Ensure scheduling, control workflow, using data indicators to plan workload, ensuring production to better meet Cryopak's targeted targets., • Maintain and enhance the efficiency of production, initiate and implement continuous improvement projects, and work with the Director of Operations to implement new processes., • Shift responsibility for maintenance ensuring all lines are operating at required capacities. Working objectively to solve problems and minimize downtime., • Ensure the training of new employees and the smooth running of production activities. WHAT YOU NEED TO SUCCEED (Qualifications): • High school diploma or equivalent, • 3 years of manufacturing experience in a similar position, • Must be bilingual (English & Spanish), • Ability to use MS Office, including Excel, • Strong organization, analytical, and management skills, • Strong communication skills (written & oral), • Ability to drive a forklift is a plus WHAT WILL SET YOU APART (Competencies): • Ability to work under pressure, • Leadership skills, • Ability to work under low supervision, • Strong interpersonal skills., • Excellent work ethic, • Ability to work in a team, • Ability to work with other departments, • Ability to work overtime and be flexible in work hours as needed WHY JOIN US: At Cryopak, we strive to offer a comprehensive benefits package that helps you and your family maintain health and well-being -both physically and financially. Our comprehensive benefits package includes: • Medical Insurance, • Dental Insurance, • Vision Insurance, • Health Savings Account (HSA), • Flexible Spending Account (FSA), • Basic Life and AD&D / Voluntary Life and AD&D, • Short-Term Disability, • Long-Term Disability, • Pet Insurance, • Commuter Transit Benefits, • 401(k) Retirement Plan w/Safe Harbor Employer Contribution, • Paid Holidays, • PTO It is Cryopak’s policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.

Responsibilities • Acts as point of contact for cross-functional teams on global labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (e.g., USPI, annotated labeling, medication guides, EU SmPC, PIL, CCDS). Independently leads cross functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as needed. Acts as point of contact for cross-functional teams on RA labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU., • Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to Core Data Sheets for assigned products. Manages US/EU and local country labeling deviations from CCDS; Ensures implementation of CCDS/labeling agreements with licensing partners., • Conduct Label Review Committee Meetings: Prepares documents for review by labeling teams. Leads review processes and ensures appropriate governance for US, EU and Company Core documents as well as for the review of country labeling deviations., • Ensure Compliance with Labeling Regulations and Guidance: Researches applicable Health Authority labeling regulations for products and filings. Manages compliance with internal and external guidelines, reviewing US and EU package inserts with regard to both content and format. Follows internal processes for record keeping and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation., • Establishes Processes and Best Practices: Reinforces labeling best practices at cross-functional meetings. Assists in the development of Standard Operating Procedures (SOPs) and process improvements. Follows agreements with external partners., • Department Coordination: Builds cross-functional and cross-regional relationships. Skills • 7 or More Years pharmaceutical industry experience required, • 4 or More Years of direct regulatory affairs experience, including US labeling experience, • Experience with ex-US labeling (outside the US) preferred Education • Bachelor's Degree preferably in a scientific discipline required

This position is part of TCS IoT and Digital Engineering horizontal business unit to drive the growth of engineering services for major Pharma customers in North America. The ideal candidate will have over 15 years of industry experience building strong client relationships, shaping proposals, and drive solution-based sales while collaborating with cross-functional teams to create business opportunities and enhance value for pharmaceutical customers. • Promote the company's engineering services to major pharmaceutical and biopharmaceutical customers, addressing key areas such as process manufacturing, regulatory compliance, and digital transformation., • Work within a multi-disciplinary team to develop proposals based on customer-specific requirements and industry regulations., • Present, promote, and sell IoT and engineering services to existing and prospective pharmaceutical clients., • Establish, develop, and maintain strong relationships with prospects and client stakeholders across manufacturing, quality, and regulatory functions., • Collaborate with clients to identify engineering challenges in areas such as recipe design and management, overall equipment effectiveness (OEE), center lining, downtime tracking, batch and material tracking, and guided operations (maintenance & changeover)., • Work with cross-functional teams to promote engineering solutions and drive new business opportunities within the pharmaceutical and biopharmaceutical sector., • Conduct market analysis, lead business planning, and develop strategic sales initiatives. Track sales progress and provide status updates., • Monitor client engagement, support business reviews, and implement measures to strengthen relationships and expand service adoption., • Drive awareness of IoT and digital engineering solutions through industry events, thought leadership, and client engagements., • Around 12 years of experience working with pharmaceutical and biopharmaceutical customers providing professional services and engineering deployments., • Strong knowledge of pharmaceutical and biopharmaceutical process manufacturing, • Experience in developing sales and account plans for a pharmaceutical customer portfolio., • Familiarity with Good Manufacturing Practice (GMP) compliance requirements, including quality risk assessment, process quality control, and assurance., • Proven track record in pursuing and selling engineering services projects valued at $5-10 million., • Established consultative relationships with pharmaceutical clients, with strong client references spanning 5+ years., • Ability to build and maintain a strong client network within the pharmaceutical sector. Bachelor's or Master's degree in engineering

Azend Pharma, a pharmacy consulting and healthcare advisory firm, is seeking a Finance Associate who brings together strong financial expertise with advanced technological skills. The ideal candidate will be a strategic thinker who can combine traditional accounting functions with automation, analytics, and process optimization to support a rapidly growing consulting organization. This role will oversee the financial operations of the company while driving efficiency through Microsoft tools, automation solutions, and data analysis, ensuring the finance function remains both accurate and innovative. Financial Management & Reporting • Oversee all accounting operations, including accounts payable/receivable, general ledger, reconciliations, and accruals., • Prepare monthly, quarterly, and annual financial statements (in compliance with GAAP Preferred)., • Conduct variance, cost, and profitability analyses on client projects and consulting engagements., • Lead audit preparation and coordination with external auditors and internal stakeholders., • Ensure compliance with regulatory, tax, and healthcare consulting financial standards. Process Automation & System Efficiency • Design and maintain advanced Excel models using VBA, Power Query, and pivot tables to streamline financial reporting., • Implement and manage Power Automate workflows for automating tasks such as approvals, reconciliations, and reporting., • Administer SharePoint for finance-related document control and workflow management., • Identify and execute process improvement initiatives that enhance accuracy, speed, and scalability in financial operations. Data Analytics & Business Insights • Analyze financial and operational data to support decision-making and business strategy., • Develop and maintain KPI dashboards for management visibility on consulting project performance and resource utilization., • Collaborate with business units to evaluate client profitability, pricing models, and financial trends., • Support budgeting and forecasting processes with data-driven methodologies. Strategic Finance Support • Partner with leadership to assess financial viability of new consulting projects or service lines., • Provide insights into cost structures, pricing, and client ROI across pharmacy consulting portfolios., • Support cash flow management and scenario planning for business growth and investment., • Uphold strong internal controls and ensure financial data integrity across systems., • Bachelor's or Master's degree in Accounting, Finance, or related discipline., • 13 years of relevant experience in accounting, finance, or consulting ideally within pharmaceutical, healthcare, or professional services., • Strong understanding of GAAP compliance, and audit practices preferred., • Advanced proficiency in:, • Microsoft Excel (VBA, Power Query, PivotTables), • Microsoft Power Automate, • Microsoft SharePoint and full Office Suite, • Experience with ERP systems (SAP, NetSuite or QuickBooks), • Excellent analytical, organizational, and problem-solving abilities., • Professional certification (CPA, ACCA, CMA) preferred., • Experience with Power BI or similar data visualization tools., • Knowledge of SQL or database integration for financial reporting., • Familiarity with RPA (Robotic Process Automation) or finance process digitization., • Experience in project accounting and cost management within a consulting or service-based firm. Work with a progressive, technology-driven consulting firm in the healthcare and pharmacy sector. Lead initiatives that merge finance, technology, and analytics to drive business efficiency. Collaborate with experts passionate about improving healthcare operations and consulting outcomes. Competitive compensation, learning opportunities, and a strong culture of innovation and integrity. Compensation: $52,000.00 - $58,000.00 per year. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. At Azend Pharma, we bring together a team of experienced pharmacy consultants with over 50 years of independent pharmacy experience. We combine industry knowledge, innovation, and a personalized approach to deliver results that exceed expectations. We specialize in empowering pharmacies to reach new heights of success through comprehensive pharmacy management consulting services. Our mission is to pioneer a future where every patient receives exceptional care. Through the relentless pursuit of operational excellence, the integration of cutting-edge innovations, and a steadfast commitment to continuous advancement, we aspire to redefine the standard of healthcare excellence worldwide.

Saama focuses on the specialized needs of pharmaceutical and biotechnology companies, delivering transformative business outcomes through AI, advanced analytics, deep life-sciences expertise, and collaborative solution development. Our teams work with global life-sciences organizations to solve complex clinical, medical, and commercial challenges using data-driven and AI-enabled solutions. The Opportunity Saama is seeking an experienced Medical Affairs Subject Matter Expert and Program Manager to lead a strategic Evidence Generation product line. This role combines deep Medical Affairs and post-marketing evidence-generation expertise with hands-on program leadership. The successful candidate will act as the primary bridge between Client stakeholders and Saamas services, product, data engineering, data science, and AI teams. The individual will help shape and deliver an AI-enabled operational and decision-support platform spanning investigator-initiated trials, research collaborations, non-interventional studies, and post-marketing/Phase IV studies. The role requires someone who can translate scientific and operational needs into an executable roadmap while maintaining rigorous governance, validation, and stakeholder alignment. • Serve as Saamas principal domain expert for Medical Affairs, Evidence Generation, and post-marketing studies., • Provide expertise across investigator-initiated trials, research collaborations, non-interventional studies, observational research, Phase IV studies, and related evidence-generation activities., • Advise on integrated evidence plans, study definitions, portfolio prioritization, scientific-review workflows, operational milestones, and performance indicators., • Facilitate workshops with scientific, medical, operational, data, and technology stakeholders to identify pain points and define future-state workflows., • Translate Medical Affairs objectives into clear business requirements, user journeys, decision frameworks, and measurable outcomes., • Ensure the solution supports scientifically credible, transparent, and decision-grade outputs., • Maintain a good understanding of how Scientific Review Committees (SRCs) evaluate investigator proposals., • Own the engagement roadmap, scope, work plan, milestones, deliverables, dependencies, resourcing, and governance cadence., • Develop and maintain phased implementation plans covering initial priorities and subsequent expansion opportunities., • Coordinate activities across Client and Saama teams, including Medical Affairs, Evidence Generation, Data and AI, Client's Digital & Architecture, Security, Compliance, Quality, Product, Engineering, and Implementation services., • Establish clear roles and responsibilities for data sourcing, preparation, validation, maintenance, and solution operations., • Manage risks, assumptions, issues, decisions, and change requests, with timely escalation and mitigation., • Lead executive status reporting, steering-committee discussions, working sessions, and decision reviews., • Manage client expectations and ensure delivery commitments remain aligned with scope, resources, timelines, and acceptance criteria., • Support commercial, procurement, and statement-of-work discussions as domain and delivery input is required., • Lead requirements definition for data ingestion, including structured and unstructured Medical Affairs and evidence-generation sources., • Partner with technical teams to define data-quality expectations, metadata models, refresh processes, lineage, ownership, and governance controls., • Guide the design of AI-enabled capabilities supporting study assessment, scientific merit evaluation, strategic alignment, risk stratification, portfolio analytics, and operational decision-making., • Help define scoring frameworks, business rules, prompts, human-review steps, and traceability requirements., • Establish measurable evaluation criteria for AI agents and analytical outputs, including accuracy, relevance, consistency, explainability, and usability., • Ensure appropriate safeguards distinguish descriptive insights from prescriptive recommendations and reduce unsupported or hallucinated outputs., • Lead or support prototype reviews, user acceptance testing, validation, release readiness, and post-deployment performance monitoring., • Ensure changing Medical Affairs strategies, evaluation criteria, and operating models can be incorporated through a controlled enhancement process., • Act as a trusted advisor to senior Medical Affairs, Evidence Generation, technology, and data stakeholders., • Communicate complex scientific, operational, data, and AI concepts in clear business language., • Build alignment across client executives, functional leaders, subject-matter experts, architects, engineers, data scientists, and delivery teams., • Conduct solution demonstrations, roadmap presentations, process reviews, and user-feedback sessions., • Develop or oversee operating procedures, process documentation, user guides, training materials, and adoption plans., • Identify opportunities to expand the solution to additional studies, therapeutic areas, or clinical-development use cases based on demonstrated value., • Maintain operational familiarity with ClinOps workflows across non-interventional studies, prospective registry studies, and Investigator-Initiated Studies., • Bachelors or masters degree in life sciences, pharmacy, medicine, public health, epidemiology, clinical research, healthcare, or a related discipline. An advanced scientific or clinical degree is preferred., • 15+ years of experience in the pharmaceutical, biotechnology, CRO, healthcare consulting, or life-sciences technology industry., • Significant experience in Medical Affairs, Evidence Generation, Real-World Evidence, post-marketing research, or late-phase clinical studies., • Demonstrated understanding of investigator-initiated trials, research collaborations, non-interventional studies, observational studies, and Phase IV programs., • Proven experience leading complex, cross-functional programs for a global pharmaceutical organization., • Ability to convert scientific and operational objectives into requirements, roadmaps, workflows, and acceptance criteria., • Experience managing senior client stakeholders, delivery risks, dependencies, governance forums, and executive communications., • Working knowledge of life-sciences data platforms, analytics, data integration, data quality, and visualization., • Understanding of regulated-system expectations, including GxP principles, data integrity, auditability, privacy, security, and applicable AI-governance requirements., • Excellent written, verbal, facilitation, presentation, and stakeholder-management skills., • Experience delivering AI, machine-learning, or generative-AI-enabled solutions in Medical Affairs or clinical research., • Experience with integrated evidence planning, evidence portfolio management, study feasibility, or scientific proposal assessment., • Familiarity with real-world data, external research databases, clinical-study metadata, and unstructured-document extraction., • Experience establishing validation approaches, human-in-the-loop controls, model monitoring, and explainability standards for AI solutions., • Background in life-sciences consulting, professional services, product implementation, or client solution delivery., • Experience with Agile delivery and tools such as Jira and Confluence., • PMP, PgMP, Agile, SAFe, or comparable program-management certification., • Experience working with globally distributed teams and willingness to travel to client locations as required., • Establish an agreed engagement roadmap, governance structure, delivery plan, and responsibility model., • Create alignment between Medical Affairs priorities and the technical solution., • Deliver clear, approved requirements and scientifically sound acceptance criteria., • Maintain predictable execution with transparent management of scope, risks, dependencies, and decisions., • Ensure AI and analytical outputs are validated, traceable, governed, and appropriate for business use., • Drive stakeholder confidence, user adoption, and measurable operational value., • Identify responsible expansion opportunities across additional evidence-generation and clinical-development use cases., • Deep life-sciences domain expertise, • Client leadership and trusted-advisor presence, • Program ownership and execution discipline, • Scientific and analytical problem-solving, • Clear executive and technical communication, • Cross-functional collaboration and influence, • Comfort operating in ambiguity, • Strong judgment, integrity, and accountability, • Innovation balanced with quality and governance Why Join Saama? • Help shape an important AI-enabled Medical Affairs and Evidence Generation transformation., • Work directly with senior stakeholders at a leading global pharmaceutical organization., • Combine scientific domain expertise with advanced data

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a product's lifecycle. Members of the organization develop global regulatory CMC strategies and partner with key stakeholders to execute the strategies in alignment with business priorities. The team also perform regulatory assessments for manufacturing changes, provides guidance on regulatory expectations for medical devices, oversees BSE program & provides compliance documents to support Health Authority submissions. The team also supports Medical Information to build/maintain database to address external questions regarding drug products. The GRS-CMC Associate Director is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support BMS products regarding: Clinical trial applications; New marketing applications; HA responses and background packages (including participating/leading HA meetings); and/or post-approval submissions. In this role, the GRS-CMC Associate Director will serve as the primary interface between Global Regulatory Sciences (GRS) and Global Product Development and Supply (GPS) or Cell Therapy Development Operations (CTDO). The GRS-CMC Associate Director will assess Manufacturing Change Controls for global impact and guide technical teams on practical aspects of global change management. Duties/Responsibilities • Represent regulatory CMC on and/or lead matrix teams for small molecules, biologics, combination and device, cell therapy products development and/or commercial products through completion of post-marketing commitments & relevant lifecycle management projects driven by research, • Independently provide strategic guidance/input related to current regulatory requirements and expectation for marketing applications, clinical trial applications for projects, and/or lifecycle changes to marketed products., • Independently manage and prioritize multiple complex projects, • Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversite from supervisor on complex topics, • Identify, communicate and propose resolutions to routine/complex issues, • Interpret global regulations and guidance. Identify regulatory opportunities and risks, • Provide strategic CMC regulatory expertise for development project teams, • Provide strategic input to development & GO teams to mitigate drug supply issues, • Interpret global regulations and guidance, • Communicate with project teams; with regards to technical issues that may impact regulatory submissions, strategy, or success, • Provide technical teams insight into regulatory health authority expectations, • Identify potential risks and help technical teams to formulate mitigation strategies to ensure regulatory success, • Ensures the necessary updates are provided to team leaders (CMCL, GRL, Line manager etc.), • Anticipate and communicate possible regulatory paradigm shifts, • Participate in product fact finding meetings, • Review and provide regulatory assessments on change controls, • Prepare and manage CMC submissions for all global markets while ensuring thoroughness, completeness and timeliness, including creation and maintenance of strategy documents, • Utilize electronic systems for dossier creation and tracking, • Support the preparation of CMC policies and procedures, • Ensure Regulatory Compliance: Maintain oversight and promote the highest standards of regulatory compliance by actively monitoring and verifying timely and accurate data entry into the Regulatory Information Management system within designated timeframes, • Looks for opportunities for continuous improvement in processes and technology solutions, • Participate in/lead teams to assess and educate on global regulatory landscape (e.g., review new policy for comment) and determine impact on global regulatory strategy Qualifications • Minimum BA/BS Degree, • 8+ years Pharmaceutical industry experience prefer knowledge of small molecules, biotechnology or cell therapy products, including multi-disciplined experience, 5+ years CMC regulatory strategy, • Knowledge of CMC regulatory requirements for advanced therapies and/or small molecules, biologics, and cell therapy during development and post-approval as applicable, • Knowledge of pharmaceutical development, including advanced therapies and/ or small molecules, biologic, and cell therapy upstream and downstream processes, analytical methods, and small molecule or biologic/device combination, cell therapy products as applicable, • Expertise in the biological, cell therapy and/or small molecule modalities, drug development process and analytical methods, preferred as applicable, • Inter-dependent partnering skills, team-oriented and ability to influence outcomes, • Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within BMS and across alliance, • Must be able to innovate, analyze and solve problems with minimal supervision and attention to details, • Demonstrates ownership of results within (and beyond) area of responsibility, • Sets clear and high expectations and holds self and others accountable for decisions and results achieved, • Looks for opportunities for continuous improvement, • Strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional, and geographic boundaries to achieve company goals, • Communicates opinions, facts and thoughts with clarity, transparency, and honesty, • Experience applying project management techniques within teams. Experience in effectively managing meetings, • Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives, • Demonstrated ability to facilitate issue resolution and conflict management, to negotiate and influence others; ability to drive quality decision making, to organize and prioritize tasks and negotiate, • Demonstrated ability to coordinate global activities, • Ability to identify, communicate and resolve complex issues, • Prepare and manage filings and ensure thoroughness, accuracy and timeliness, • Ability to interpret global regulations and guidance, • Strong oral and written skills, • Proficient with electronic systems, • This position may require up to 5% of travel If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Madison - Giralda - NJ - US: $164,020 - $198,759 New Brunswick - NJ - US: $164,020 - $198,759 Princeton - NJ - US: $164,020 - $198,759 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: • Health Coverage: Medical, pharmacy, dental, and vision care., • Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP)., • Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. ? Work-life benefits include: Paid Time Off • US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees), • Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager to join our Regulatory Affairs Advertising and Promotion team. In this role, you will apply clinical development knowledge in concert with experienced understanding of advertising and promotion regulations/guidances to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). This individual will provide regulatory advertising and promotion expertise to relevant stakeholders, typically carrying out the responsibilities with guidance from the Regulatory Affairs, Advertising and Promotion Director. The Manager Regulatory Affairs, Advertising and Promotion will oversee therapeutic area(s) and ensure that messages are translated into advertising and promotion initiatives that meet the commercial team's objectives, while maintaining the necessary state of compliance and corporate integrity. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. Work Location: Sleepy Hollow, NY or Warren, NJ 4 days per week on site Discover your role: • Management of US regulatory activities associated with advertising and promotion of the company's marketed products. Manages commercial activities from a regulatory advertising and promotion perspective with guidance from the Regulatory Affairs, Advertising & Promotion Director., • Creatively contribute to the advise on the development of product messages and materials across multiple functional areas., • Provide timely regulatory advice and guidance, with guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs, • Provide review of US and Global (if applicable) product and disease state materials/communications, with guidance from Regulatory Affairs, Advertising & Promotion Director, to support corporate goals and comply with applicable laws, regulations, and guidance., • Collaborate cross functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal., • Responsible for establishing working relationship and managing communication with regulatory advertising and promotion professionals at co-promote partner companies, • Help lead and assist in all interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, responsible for helping to maintain working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters, including request for advisory submissions., • Responsible for compliance with promotional material submissions to FDA on Form 2253, • Monitor the external environment to advise product teams on evolving regulatory requirements related to product and disease state communications, • Maintain vigilance with respect to FDA promotional enforcement activities; provide stakeholders with updates on a regular basis; in partnership with management, provide guidance to stakeholders with respect to impact of enforcement activities on the company policies., • Ability to identify process improvement for promotional review activities that would enable the establishment of portfolio wide standardization of policies, • Ability to cross train across products/indications to ensure continuous Regulatory A&P support is provided to stakeholders, • Collaboration with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports, • With guidance from management, help provide input during review cycles to reflect commercialization objectives and messages in the submission documents/reports that are submitted to health authorities, • Provide input to management during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising. This role requires: • A minimum of 2 total years relevant experience, preferably within Regulatory Advertising and Promotion, • At minimum, a Bachelor's degree (BS) from an accredited college or university in Life Sciences. An Advanced Scientific degree (i.e., Masters, PharmD, Ph.D) is preferred., • Knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of advertising and promotion, • Experience with pharmaceutical products required, biologics experience is a plus, • Experience working directly/indirectly with the FDA, specifically OPDP/APLB is preferred, • Ability to review promotional materials and interact with FDA OPDP/APLB and support launch products/campaigns, while maintaining excellent written/verbal communication skill when giving strategic regulatory advice, • Ability to support global promotional review, understanding of clinical trial recruitment materials, and familiarity with labeling regulations is desirable, • Contributes to the influence of cross-functional teams and may interact with senior management

Pay Rate $47.00 49.15/hr on W2 Location: Warren, NJ 07059 Duration: 12 Months Day Shift: 8 am - 5 PM Job Description: Regulatory Affairs Senior Associate The purpose of this role is to execute OTC regulatory activities for new products registrations and life cycle. Maintenance for the portfolio of products defined by the US Business Units. Key Responsibilities: • Represent USRA on assigned projects, provide guidance on OTC drug regulatory pathways (monograph, NDA)., • Develop regulatory strategies and documents for new product launches and maintenance of current products aligned with the regulations., • Develop regulatory label for OTC products, review claims and copy., • Participate in the review of promotional materials., • Support end-to-end regulatory compliance of products in remit., • Applies system and procedure updates to maintain up to date technical product records., • Identifies and participates in process improvements within US Regulatory Affairs., • Interact with colleagues in other global functions to support global programs., • Effectively communicates regulatory technical requirements and guidelines, facilitating timely and complete submissions., • Develop up-to-date knowledge of guidelines and regulatory requirements, as well as technical trends. Qualifications: • Bachelor's degree in Pharmaceutical or Life Sciences or equivalent regulatory experience., • 2-4 years' experience in regulatory affairs including chemistry, manufacturing and controls, and over the counter experience, preferably within a Client/Consumer Healthcare/Pharma related industry., • Experience and knowledge in Quality, product development and manufacturing areas., • Experience working on FDA applications, OTC monograph products, chemistry, manufacturing and controls., • Proficient knowledge in US FDA regulations., • Regulatory Affairs Senior Associate., • Excellent communications skills, stakeholder management and enjoys working in multidisciplinary teams., • Ability to manage prioritize projects of high complexity., • Experience leading end-to-end regulatory process in new product launches. Additional Preferred Qualifications: • Knowledge and experience of US regulatory framework for OTC drugs, OTC medical devices., • Ability to ensure compliance standards and key performance indicators are met., • Regulatory expertise in knowledge of the regulatory lifecycle., • Ability to interact at many levels., • Technical knowledge., • Minimum 2 years of experience in regulatory affairs. Competencies and Skills: • Agile, attention to detail, written and verbal communication skills using evidence and applying judgement to balance pace, rigor and risk.