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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 1st shift - 7:00 am to 3:30 pm

Job Title: Quality Control (QC) Manager Industry: Nutraceuticals / Dietary Supplements (CDMO) Location: New Brunswick, NJ Job Summary The Quality Control (QC) Manager is responsible for overseeing all laboratory and quality control functions within a dietary supplement CDMO environment. This role ensures that raw materials, in-process samples, and finished products meet established specifications and comply with regulatory requirements including FDA 21 CFR Part 111 and cGMP standards. The QC Manager will lead laboratory operations, manage a team of analysts, and support timely product release while maintaining the highest standards of quality, safety, and data integrity. Responsibilities • Oversee testing of raw materials , in – process samples and finished products ., • Ensure compliance with product specifications and release criteria, • Review and approve Certificates of Analysis (COAs), • Manage sampling plans, test schedules, and batch release timelines, • Supervise day-to-day QC laboratory operations (chemical and microbiological testing), • Ensure proper calibration, maintenance, and operation of analytical instruments (HPLC, GC,, • UV-Vis, etc.), • Maintain laboratory SOPs, test methods, and documentation, • Support internal, customer, and regulatory audits, • Maintain audit readiness and address observations, • Lead investigations for OOS (Out-of-Specification) and OOT (Out-of-Trend) results, • Lead, train, and mentor QC analysts and lab personnel, • Manage team performance, hiring, and development, • Promote a strong quality and compliance culture, • Partner with QA, Manufacturing, R&D, and Supply Chain teams, • Support product development, scale-up, and tech transfer activities, • Drive improvements in lab efficiency, turnaround time, and cost optimization Qualifications • Bachelor’s or Master’s degree in Chemistry, Biochemistry, Microbiology, Food Science, or, • related field, • 5+ years of experience in Quality Control within dietary supplements and nutraceuticals., • Experience in a CDMO or contract manufacturing environment preferred, • Hands-on experience with analytical techniques such as HPLC, GC, UV-Vis (ICP-MS is a plus), • Strong knowledge of microbiological testing methods, • Experience with method validation and stability studies, • Ability to work in a fast-paced, multi-client CDMO environment, • Effective communication and stakeholder management

Design Space InPharmatics, a leading international pharmaceutical consulting organization, is seeking an experienced Regulatory Medical Writer to support NDA submission programs for our growing portfolio of drug development clients. We are looking for a consultant with demonstrated expertise authoring and compiling FDA New Drug Application (NDA) submissions, specifically NDA Module 2 and Module 5 content in CTD/eCTD format. The ideal candidate will bring strong experience in clinical regulatory writing, integrated summaries, clinical study report development, and NDA submission strategy across small molecule and/or biologic drug products. This is a high-impact consulting engagement offering flexibility, and meaningful work at the forefront of regulatory drug development. Role and Responsibilities In this high-impact consulting role, the Regulatory Medical Writer will provide expert-level authoring and regulatory documentation support across a range of FDA NDA submission programs. Working remotely within a collaborative consulting team, the successful candidate will: • Author, edit, and compile NDA Module 2 clinical summaries and overviews, including Clinical Overview (Section 2.5), Clinical Summary (Section 2.7), Benefit-risk assessments and Integrated summaries of safety and efficacy., • Prepare and/or manage NDA Module 5 clinical documentation, including Clinical study reports (CSRs), Protocols and protocol amendments, Statistical analysis plans (SAPs), Case report tabulations, and listings coordination., • Ensure all documents comply with FDA guidance requirements, ICH CTD/eCTD standards, Good Clinical Practice (GCP), and internal quality and style standards., • Participate in submission planning, document gap assessments, and submission readiness reviews., • Support the preparation of responses to FDA information requests and review comments., • Coordinate timelines and deliverables to support NDA submission milestones., • Collaborate cross-functionally with clinical development teams, biostatistics, data management, pharmacovigilance, regulatory affairs, and medical affairs., • Function as a trusted regulatory writing subject matter expert within client project teams and CMO relationships., • Proactively flag gaps or risks relative to FDA expectations or industry best practices. Qualifications and Education Requirements • Advanced degree preferred (PharmD, PhD, MD, MS, or equivalent scientific discipline), Minimum 8–10 years of pharmaceutical or biotechnology regulatory writing experience., • Direct, hands-on experience authoring FDA NDA Module 2 and Module 5 content., • Strong knowledge of FDA NDA submission requirements, ICH E3 and CTD/eCTD structure, clinical trial documentation standards, and drug development processes. Preferred Skills • Experience with small molecule drug development programs., • Demonstrated expertise preparing integrated summaries of safety (ISS) and integrated summaries of efficacy (ISE)., • Familiarity with publishing systems and eCTD submission platforms., • Prior interaction with FDA review teams or support during regulatory agency meetings., • Consulting experience supporting multiple sponsors or parallel drug development programs., • Excellent scientific writing, editing, and data interpretation skills., • Ability to work independently and manage multiple deliverables in a fast-paced consulting environment. Additional Notes • Candidates who bring experience across both small molecule and biologic programs, or who have supported multiple NDA submissions across different therapeutic areas, will be especially well regarded. The responsibilities outlined in this position represent a general summary of the consulting role and are not intended to be all-inclusive. DSI reserves the right to amend this description as client program needs to evolve., • This is an excellent opportunity for a seasoned regulatory writing professional seeking to apply their expertise within a dynamic, market-leading consulting organization at the forefront of pharmaceutical regulatory strategy and drug development services., • This is a fully remote, independent consultant role. Consultants are engaged on a project basis and may be assigned to one or multiple concurrent engagements. Hours are not fixed and will fluctuate based on project requirements, milestones, and client needs., • All applications are reviewed by our human hiring team. No automated screening or AI-based filtering is used to evaluate or eliminate candidates. Every candidate receives personal consideration.

CAREER OPPORTUNITY | MANUFACTURING & OPERATIONS Maintenance Manager Posted: May 2026 | Location: Woodstock Farms – Edison, NJ | Requisition: MFG-MM-2026 Department: Maintenance / Facilities Employment Type: Full-Time Reports To: Plant Manager / Director of Operations FLSA Status: Exempt ABOUT THE ROLE We are seeking an experienced and driven Maintenance Manager to lead our maintenance department and serve as a cornerstone of operational excellence at our manufacturing facility. In this role, you will be responsible for maximizing equipment uptime, overseeing comprehensive preventive and predictive maintenance programs, and ensuring the plant operates safely, efficiently, and reliably at all times. You will lead a team of skilled maintenance technicians, foster a culture of accountability and continuous improvement, and partner closely with production, engineering, and quality leadership to meet the highest standards of plant performance. If you are a proactive leader with a passion for reliability, safety, and operational impact, this is an outstanding opportunity to make a lasting difference in a growing organization. KEY RESPONSIBILITIES ● Lead, supervise, and develop a team of maintenance technicians and support staff, including scheduling, performance management, mentoring, and skills training programs. ● Design, implement, and continuously improve preventive and predictive maintenance (PM/PdM) programs to maximize equipment reliability and reduce unplanned downtime. ● Ensure full compliance with all applicable safety regulations, including OSHA standards, NFPA codes, and internal environmental health and safety (EHS) policies. ● Develop and manage the annual maintenance budget, control parts and materials inventory, and negotiate and maintain relationships with external vendors and contractors. ● Coordinate and prioritize equipment repairs across the facility, working closely with production leadership to minimize disruption to manufacturing operations. ● Oversee the installation, commissioning, startup, and modification of new and existing plant equipment and systems. ● Implement and optimize a Computerized Maintenance Management System (CMMS) to track work orders, maintenance history, asset data, and KPIs. ● Define, monitor, and report on key maintenance performance indicators (KPIs) including OEE, MTBF, MTTR, and PM compliance rate. ● Collaborate cross-functionally with production, engineering, and quality assurance teams to align maintenance activities with plant priorities and operational goals. ● Lead root cause analysis (RCA) investigations for equipment failures and drive corrective and preventive action plans to resolution. ● Champion continuous improvement initiatives using methodologies such as TPM (Total Productive Maintenance), Lean Manufacturing, and 5S throughout the maintenance department and plant floor. ● Ensure thorough and accurate documentation of all maintenance records, work orders, equipment logs, and regulatory compliance documentation. ● Maintain a safe and organized maintenance shop, ensuring proper storage and handling of parts, tools, chemicals, and hazardous materials. QUALIFICATIONS ► Required Qualifications ● Bachelor's degree in Mechanical Engineering, Electrical Engineering, Industrial Engineering, or a related field — or equivalent hands-on professional experience in lieu of a degree. ● Minimum of 5 years of maintenance experience in a manufacturing or industrial environment, with demonstrated expertise across multiple systems and disciplines. ● Minimum of 2 years in a supervisory, team lead, or maintenance management role, with direct responsibility for personnel performance and development. ● Strong working knowledge of mechanical, electrical, hydraulic, and pneumatic systems, including the ability to interpret schematics, drawings, and technical specifications. ● Hands-on experience with CMMS software platforms (e.g., SAP PM, Maximo, eMaint, Fiix) and proficiency in Microsoft Office Suite (Excel, Word, Outlook). ● Solid understanding of OSHA regulations, NFPA standards, safety compliance requirements, and best practices for industrial workplace safety. ● Proven ability to manage competing priorities in a fast-paced manufacturing environment with strong analytical and problem-solving skills. ► Preferred Qualifications ● Demonstrated experience with Lean Manufacturing, Total Productive Maintenance (TPM), or Six Sigma methodologies; Green Belt or Black Belt certification is a plus. ● Familiarity with PLC’s, HMI systems, variable frequency drives (VFDs), and industrial automation platforms (e.g., Allen-Bradley, Siemens). ● Professional certification such as CMRP (Certified Maintenance & Reliability Professional) issued by SMRP, or equivalent industry credential. ● Experience managing maintenance functions in a regulated manufacturing environment (FDA, ISO, or similar quality management frameworks). WORK ENVIRONMENT & PHYSICAL REQUIREMENTS This position is based on-site at an active manufacturing facility. The work environment includes regular exposure to industrial machinery, elevated noise levels, variable temperatures, and chemical substances. Candidates must be comfortable working on the production floor for extended periods and must consistently adhere to all site safety protocols. ● Must be able to stand, walk, bend, and move throughout the plant for extended periods during each shift. ● Occasional lifting, pushing, or carrying of objects and equipment up to 50 lbs. ● Required to wear appropriate Good Manufacturing Practices (GMP) & PPE (when needed) at all times on the plant floor, including hair net, beard net, ear plugs, and steel-toed boots. ● May require on-call availability for unplanned equipment failures or critical production issues outside of standard business hours. ● Occasional weekend or evening work may be required during scheduled maintenance windows, equipment shutdowns, or periods of high operational demand. Note: This is a full-time, on-site position. Remote or hybrid work arrangements are not available for this role due to the hands-on nature of plant operations. WHY JOIN US We are committed to investing in our people and building a workplace where talented professionals can grow, thrive, and do their best work. Here is what you can expect when you join our team: ● Competitive Compensation: Market-leading base salary paired with a performance-based annual bonus program that rewards results and reliability. ● Comprehensive Benefits Package: Full medical, dental, and vision coverage for you, plus a 401(k) retirement plan with a generous company match. ● Paid Time Off & Holidays: PTO policy and company-paid holidays to support work-life balance and personal well-being. ● Career Growth & Development: Clear advancement pathways, tuition assistance, professional certification support, and continuous learning opportunities within a growing organization. ● Safety-First Culture: A collaborative, respectful, and safety-focused work environment where every team member's voice is valued and every contribution matters. ● Meaningful Impact: A unique opportunity to take direct ownership of plant reliability and maintenance excellence — with the autonomy, resources, and leadership support to drive real, measurable operational results. This job description is intended to describe the general nature and level of work performed. It is not an exhaustive list of all responsibilities, duties, and skills required. Management reserves the right to modify this description at any time. Our company is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Summary We are seeking an experienced Manufacturing Process Engineer with experience in powder-based manufacturing, with a strong chemistry background to lead and optimize manufacturing operations. This role is responsible for the design, improvement, and oversight of production processes, ensuring efficiency, quality, safety, and regulatory compliance. The ideal candidate combines hands-on plant experience with technical leadership, customer interaction, and cross-functional collaboration to drive continuous improvement across operations. Key Responsibilities • Design, develop, test, and improve mechanical systems, equipment, and process applications., • Analyze and optimize chemical and manufacturing processes to increase throughput, improve efficiency, and reduce waste., • Schedule and manage production operations involving blending, milling, drying, and screening equipment for maximum efficiency., • Lead employees across production and technical operations., • Oversee preventive maintenance and downtime activities to ensure operational reliability., • Conduct client laboratory testing, including data intake, feasibility studies, process development, optimization, and final reporting; ensure high client satisfaction., • Perform root cause analysis on process failures and implement corrective and preventive actions., • Manage operational budgets and present performance metrics and financial results to leadership., • Collaborate with operations, R&D, quality, and regulatory teams to implement new or improved processes., • Develop, maintain, and manage technical documentation, including SOPs, certifications, regulatory filings, and compliance records., • Ensure full compliance with FDA, DEP, EPA, cGMP, SQF, and other applicable regulatory and safety standards. Qualifications • Bachelor’s degree in Chemical Engineering, Process Engineering, or a related field., • Minimum of 5+ years of process engineering experience, • Experience in powder-based manufacturing within pharmaceutical, nutraceutical, cosmetic, or chemical industries., • Hands-on experience with laboratory equipment, including particle size analyzers, microscopes, moisture balances, and scales., • Proven ability to work directly with customers and present technical findings., • Strong understanding of chemical engineering fundamentals, including fluid dynamics, thermodynamics, and heat transfer., • Knowledge of industrial electrical control panels and their integration with manufacturing equipment., • Strong regulatory background, with responsibility for maintaining FDA, DEP, EPA, cGMP, SQF, and related programs., • Proficiency with CAD and process simulation software is a plus., • Excellent analytical, problem-solving, and organizational skills.

The Corporate Counsel is responsible for managing various legal matters pertaining to Terumo Americas Holding, Inc. and certain of its subsidiaries and affiliates (collectively “TAH”), including clinical and medical affairs, commercial operations, contracting, healthcare compliance, employment law, corporate governance and intellectual property matters. Additionally, the Corporate Counsel will work with VP & Deputy General Counsel – Legal to develop long and short-term plans pertaining to legal matters to best manage TAH’s legal activities and minimize the risk to the business. Provide legal support and advice to TAH management and various internal business functions. Provides business with effective advice on company strategies and their implementation while ensuring adherence to state, federal, and international laws and regulations. Oversees reviewing, drafting, and negotiation of various commercial agreements. Will be responsible for protecting TAH against legal and compliance risks. Job Details: • Prepares, drafts, reviews, negotiates and modifies a wide variety of commercial contracts and other documents with legal significance, including but not limited to clinical trial agreements, sales agreements, GPOs, procurement agreements, consulting agreements, business development agreements, clinical affairs agreements, and confidentiality agreements., • Identifies, researches and provides advice on complex legal and commercial compliance issues and develops resolutions to those issues., • Exercises considerable judgment in identification of risks and proposals of alternative solutions to mitigate risks involved in potential transactions., • Assist in the identification, delivery of advice on and resolution of highly complex legal and commercial compliance issues., • Assists on strategic transactions and other mission critical initiatives., • Identifies the need for, initiates and develops language for the implementation of legal or commercial compliance policies., • Assists in the preparation and maintenance of corporate records for various TAH entities worldwide., • Stays current on developments in applicable laws, regulations and industry codes of ethics and practices., • Oversee the selection, management and evaluation of all outside counsel., • Interprets laws, rulings and regulations for the company and recommends appropriate changes or actions., • Maintain compliance with all Quality System requirements by maintaining a strong working knowledge of assigned training requirements. Fully adhere to all applicable government regulations, international guidelines and Terumo’s policies at all times. Establish and promote a work environment amongst co-workers that supports compliance with the Quality System and Terumo’s policies., • Perform other job-related duties as assigned. Position Requirements: • Knowledge, Skills and Abilities (KSAs), • Demonstrate understanding of market challenges, organizational scale requirements, and the legal processes needed to support a rapidly growing company., • Strong communication skills, including written communications, presentations, rapport building, negotiating and influencing skills., • Excellent team leadership and collaboration skills with internal clients, external collaborators or partners, and other stakeholders., • Adept at the leadership and management of change with the ability to diagnose and solve problems, articulate a plan, and implement solutions., • Basic understanding of FDA Regulations, the Sarbanes-Oxley Act, and knowledge of U.S. health care compliance and global anti-corruption and anti-bribery laws and regulations (e.g., FCPA, Stark and Anti-Kickback)., • Extensive knowledge and experience in clinical and medical affairs, contract law, health care law, intellectual property law including patent law and licensing, and employment law., • Broad knowledge of relevant laws and regulations, analytical ability, business savvy, and a balance of legal, compliance and operational experience. This team player must relate well to all levels of employees and external stakeholders., • Knowledge of Word Processing, Spreadsheet, Database, and Internet software., • Background Experiences, • Requires Juris Doctor from an accredited law school. Member of the bar in good standing; admission to New Jersey state bar preferred., • Minimum 6 years’ of legal experience in a relevant law firm or corporate setting., • Medical device, pharmaceutical, life science, or other healthcare related experience preferred., • Experience managing and dealing effectively with a broad range of legal matters across the spectrum of clinical and medical affairs, commercial contracting, employment law, compliance programs, intellectual property, mergers and acquisitions, product liability and any and all laws and statutes related to the healthcare industry., • Experience dealing with international organizations and the broad issues encountered while dealing with differences of opinion and approach to international business issues.

Number ICIMS-2026-9770 Job function QA&RA Job type Full-time Location Werfen - Warren - Warren, New Jersey United States Country United States Shift 1st Introduction Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview If you're a QC expert when it comes to manufacturing, Immucor has an exciting opportunity for you! We are looking to hire a Quality Control Technologist III medical device, and/or the pharmaceutical industry. This critical role will Lead QC stability projects, perform Incoming, In-process, final release and stability testing in the Quality Control Laboratory. Act as Team Lead in the QC lab to assist supervisor and Director in daily operations of the Quality Control Laboratory and provide guidance to the QC staff. This position is not eligible for sponsorship for work authorization by Werfen. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time. Responsibilities Job Summary This role will be the team SME (subject matter expert) on product stability. This will include writing stability protocols and reports, performing product testing, and trending stability data. They may lead QC projects, perform Incoming, In-process, final release, and stability testing in the Quality Control Laboratory. They will be a Team Lead in the QC lab to assist the supervisor/ manger and Director in daily operations of the Quality Control Laboratory and provide guidance to the QC staff. Key Accountabilities • Monitors stability testing time points, ensures samples are pulled and tested at the correct intervals, and performs data analysis to support QA/QC management. Drafts stability protocols and reports. Performs trend analysis onstability data throughout the stabiity protocol timeline. Develops timeline for annual stability and determines which products are required., • Provides direction and guidance to Quality Control staff in the performance of daily tasks. Creates daily and weekly scheduling of all QC related activities, • Performs and schedules testing for incoming raw material, in-process, final release and inspection of BioArray products according to approved Standard Operating Procedures (SOP's) and other applicable documents within defined timeframes. Performs and schedules stability, method validations, equipment validations, threshold analysis process and other special testing., • Act as OJT trainer to train new employees and current employees on new test methods. Guides QC technicians training activities and ensures that the appropriate training records are completed as per the role functions, • Reports and escalates out-of-specification results and deviations to the department supervisor/manager. Assists and leads the investigations, root cause analyses, and reports for out-of-specification results and deviations., • Writes/Revises SOPs, WI, QC Specification/testing documents. Maintains accurate, legible, and complete records according to Current Good Manufacturing Procedures (cGMP's)., • Performs all assigned tasks following applicable laboratory SOPs, OSHA regulations and cGMP regulations (i.e. Blood borne pathogens and chemical hazards)., • Maintains work area, equipment, department, and all storage areas in a clean, neat, and orderly manner. Performs, schedules and delegates equipment calibration and manintenance. Qualifications • Bachelor's degree in biology or chemistry or related field. Four (4) or more years experience in a medical device or pharmaceutical GMP quality laboratory. Experience working under 21 CFR Part 210/211 and/or 820 regulations required. Knowledge of ISO 13485 desired., • Two (2) or more years of experience performing stability testing required. Experience writing stability protocols, performing data trending, and writing stability reports preferred., • Experience performing OOS Phase I investigations, in alignment with FDA guidelines, required., • Expereince training QC technicians desired., • Expereience performing PCR (Polymerase chain reaction) desired., • Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement. Quality Control Technologist III-Stability If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. www.werfen.com _

Position Summary: The Packaging Operator is responsible for operating packaging line equipment, handling materials, and ensuring compliance with safety, quality, and regulatory standards. This role requires attention to detail, adherence to SOPs, and effective communication to maintain smooth and efficient packaging operations. Education Required High School Diploma or Equivalent Required Experience Required: 1-2 years’ experience in FDA regulated packaging environment desired. Specialized or Technical Knowledge, Licenses, Certifications required Proficient in navigating HMI screens for various packaging equipment, including Tablet/Capsule Filler, Cottoner, Capper, Desiccant Inserter, Checkweigher, Labeler, Case Former, and Pallet Jack. Ability to assist Packaging Technicians during line changeovers. Capable of working extended hours and maintaining focus under challenging conditions.

Job Details The Manager/Senior Manager Strategic Portfolio and Business Development within our Strategic Portfolio and Business Development (SPBD) organization will play a crucial role in supporting the strategic growth initiatives for the organization. The successful candidate will be responsible for analyzing and evaluating potential product, portfolio, and company collaboration and acquisition opportunities, providing comprehensive reports and recommendations to the Business Development and Portfolio functions, and for ensuring that the department meets company's immediate and long-term growth objectives. Job duties: • Product Analysis: Conduct thorough analysis of potential product opportunities, including forecasting and financial modeling, market research, and due diligence., • M&A and Mature Brand Acquisition: Conduct analyses of potential company and mature brand target acquisitions monitoring for overlap and strategic Padagis pipeline and technology augmentation., • Business Case Preparation: Prepare thorough business cases at the product and company level., • Maintain Business Development Hunt List: Maintain product details for ideal inorganic pipeline augmentation., • Segment Analysis: Macro (and product level as needed) analysis for segments in pharma market (by dosage form or indication or mode of action or drug category) that would inform strategic investment decisions in that segment., • Reporting: Prepare detailed reports and presentations for senior management, offering insights and recommendations based on the latest data and market developments., • Strategic Planning: Collaborate with the SPBD, and other cross functional teams to develop strategic plans for portfolio growth and drive insights from the organizations long range planning., • Risk Management: Assess and manage risks associated with product opportunities, ensuring alignment with the company's risk tolerance and investment criteria., • Market Research: Stay abreast of market trends, industry developments, and partner / CDMO activities to inform product decisions and strategy., • Liaise with other functions on topics such as new project due diligence kick-off meetings, R&D project feasibility and updates, legal assessment and updates, launch management, operations planning, and commercialization/competitive scenarios., • Update portfolio information tools, reports and databases as new information becomes available. Required qualifications: • Bachelor's degree in Pharmaceutical Sciences, Finance, Economics, Business Administration, Intellectual Property Management or a related field., • Minimum of 5 years of professional pharmaceutical experience; minimum of 2 years of experience in product ideation, business development, market research or pipeline valuation within the US pharmaceutical industry with preference for generics., • Strong analytical and quantitative skills, with the ability to interpret scientific and financial data., • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and other relevant software. Preferred qualifications: • Master's degree, • Exposure to pharmaceutical datasets and analytics tools (e.g. IQVIA, Cortellis, Global Data, IPD Analytics, PriceRx, FDA websites) is highly preferred., • Experience in generic pharmaceuticals industry Padagis Key Competencies: Since its beginning, Padagis has been undergoing the process of identifying what we believe will lead to the success of our organization in a competitive landscape. To that end, we have developed a set of five "core" competencies. We strive to bring employees on board the journey with us who exemplify these key competencies: • Service delivery - Understand who your internal and external customers are, identify their needs, and deliver value above their expectations..., • Active collaboration - Seek opportunities to work together across teams, function, business units, and geographies to seek success..., • Demonstrate agility - Proactively identify changes in our environment and act quickly, leading or embracing change..., • Think differently - Create, develop, and implement new ideas, products, services, or processes that involve introducing something new or significantly improving something that already exists..., • Excellent execution - Achieve outstanding results in all aspects of our organization, including our culture, leadership, strategy, and processes... About us: At Padagis our focus is on health care products that improve people's lives. We are a market-leading generic prescription pharmaceutical company that specializes in "extended topical" medications, like creams, foams, mousses, gels, liquids and inhalable products. It's a great time to join our team because we have a high growth trajectory with now more than 1,300 employees across six locations in the United States and Israel. We've already established a successful track record of launching first-to-file and first-to-market generic pharmaceutical products that have helped to make prescription products more affordable for patients and reduce costs for the healthcare system. Our team members work in a dynamic environment where opportunity is built on a foundation of honesty and transparency. Please consider joining our team where great things are happening and you can make a difference. What's Next: At Padagis a real recruiter AND the hiring manager will review your application, not just a bot. This means we pay special attention to each application submitted for the position. While it could take a couple of days for us to get back with you, please know that we appreciate you applying for the open position and ask that you monitor your email. Experience5 years: Professional pharmaceutical experience (required) Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the _ notice from the Department of Labor.

AML/BSA program evaluation) - Provide structured feedback on AI accuracy in areas such as regulatory standards (FINRA, OCC, FFIEC, FDA, SEC, GDPR, HIPAA), risk frameworks (COSO, ISO 31000), and industry-specific compliance terminology - Collaborate asynchronously with research teams to refine evalua

QA-ready reporting Maintain detailed, compliant documentation in accordance with FDA cGMP requirements Support method development, verification, validation, and transfer activities Participate in investigations including deviations, OOS/OOT, and CAPA Maintain laboratory equipment including calibrati

Job DescriptionWe are seeking two motivated Laboratory Technicians to support our Analytical Research & Development (ARD) team. These roles will play a key part in supporting a growing product pipeline, with multiple new product launches anticipated this year.Key Responsibilities • Perform analytical testing on raw materials, intermediates, and finished pharmaceutical products, • Support method development, validation, and transfer activities, • Operate and maintain analytical instrumentation, including:, • HPLC / UPLC, • GC, • Dissolution systems, • UV/Vis spectrophotometers, • Prepare samples, reagents, and solutions in accordance with SOPs, • Maintain accurate documentation in compliance with cGMP and FDA regulations, • Assist with investigations related to OOS (Out-of-Specification results), deviations, and CAPAs, • Ensure laboratory cleanliness, safety, and organization, • Collaborate effectively with ARD scientists and cross-functional teamsRequired Qualifications, • Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a related field, • 1–3+ years of laboratory experience (pharmaceutical industry preferred), • Hands-on experience with analytical instrumentation (e.g., HPLC), • Knowledge of cGMP environments and documentation practices, • Strong attention to detail and organizational skillsPreferred Qualifications, • Experience in Analytical R&D or Quality Control laboratories, • Exposure to ANDA or pharmaceutical product development environments, • Experience supporting method validation or transfer activities, • Background in regulated pharmaceutical manufacturing settingsFull Benefits/Medical, Dental, Vision+ Pay Rate: $30.00 to $38.00 per hour Zing Recruiting, a Peoplelink Group company, is an equal opportunity employer. We are committed to fostering a diverse and inclusive workplace and prohibit discrimination or harassment of any kind. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other protected characteristic under applicable law. #ZINGNJ #ZINGZIP #LI-ST1Company DescriptionZing Recruiting is dedicated to delivering candidates and client’s alike a great experience for each unique position. We specialize in finding dedicated professionals with the education, talent, and fresh perspectives – professionals at the top of their game. Professionals who have what it takes to be competitive and innovative in today’s market. We work to match candidates needs and requirements to our clients’ requirements and expectations. We work to find the right “fit” for both candidate and client.Zing Recruiting is dedicated to delivering candidates and client’s alike a great experience for each unique position. We specialize in finding dedicated professionals with the education, talent, and fresh perspectives – professionals at the top of their game. Professionals who have what it takes to be competitive and innovative in today’s market. We work to match candidates needs and requirements to our clients’ requirements and expectations. We work to find the right “fit” for both candidate and client.

Job Description Company Overview: We are a dynamic and innovative small biotechnology company dedicated to advancing oncology research through cutting-edge translational science. Our mission is to translate scientific discoveries into tangible therapeutic solutions that make a meaningful impact on cancer patients' lives. We are seeking a talented and motivated Translational Scientist to join our team and contribute to our mission-driven work. Position Overview: As a manager of clinical pharmacology you will be responsible for providing clinical pharmacology input in early (up to proof-of-concept stage) and late-stage clinical development. You will be responsible for representing clinical pharmacology function on drug development teams, providing input on the dose and the design of early and late-stage clinical trials, and for interacting with the clinicians and the clinical operations group for the execution of the clinical pharmacology components (PK, PD, biomarkers, etc) of the trials. In addition, you will be responsible for performing clinical PK/PD analyses, for providing subject matter leadership related to clinical ADME, pre-clinical to clinical extrapolation and selection of dose/regimen during early development. Additionally, you will be responsible for providing input on study design and leading the selection of doses for late-stage clinical studies. You will contribute to the preparation of the regulatory documents such as briefing books for pre-agency meetings, IBs, INDs, and IMPD dossiers, protocols, and clinical study reports. You will closely collaborate with other development-functions (Toxicology, Bioanalytical, Non-clinical PK/PD, Pharmacometrics and Physiological PK/PD Modeling and Simulation, Biomarkers, Biostatistics and Data Management, Clinical Operations, and Clinical Development) to bring drug candidates from IND stage to NDA. You will be responsible for working within the department level budget and resources. Support technical due diligence efforts for business development. Responsibilities: • Responsible for providing support for the preparation of the clinical pharmacology (PK, biomarkers, bioanalytical) sections of early and late-stage clinical protocols, Clin Pharm development plans, modeling & simulation plans, • Contribute to the preparation of the pre-IND, IND, IB and NDA/BLA documents, • Responsible for the pharmacokinetic and PK/PD data analyses using standard industry data analysis software, • Contribute to the design of early phase clinical trials (FIH to POC) and support project goals, • Responsible for recommending the starting dose in FIH trials based on allometric scaling or physiologically based PK modeling, • Conduct assessments of relevant exposure vs. response data for supporting dose selection during and post POC, • Contribute to the design of late-stage clinical trials (POC-NDA/BLA) and support project goals, • Responsible for leading the dose selection for Phase II and III clinical trials based on PK, PD biomarker and efficacy data analysis from previous studies., • Responsible for the preparation of the PK/PD reports and clinical study reports, • Represent Clin Pharm function for the project team at the regulatory agencies during regulatory meetings., • Provide clinical pharmacology input and collaborate across all areas of drug development, along with research, preclinical, bioanalytical and clinical development functions., • Provide oversight to vendors and ensure high quality deliverables that meet study/project timelines, • Develop standard working procedures for operation and data analysis Experience: • 3+ years of pertinent post-doctoral experience in supporting pharmacokinetics, pharmacodynamics and other clinical pharmacology components of early clinical trials within the pharmaceutical or biotech industry., • Exposure to biologics drug development. Knowledge of basic and clinical immunology is plus., • Hands on knowledge of PK/PD and statistical analyses methods used in analyzing early clinical phase data., • Knowledge of general regulatory process and experience in contributing to IND, EOP1, EOP2, and pre-BLA/NDA meetings with the FDA , EMA and other health authorities., • Excellent written and oral communication skills including good presentation skills. Qualifications: • Doctoral degree (PhD or Equivalent training by experience) in clinical pharmacology, pharmacokinetics, pharmacology, or relevant life science discipline such as biology, immunology., • Hands-on experience with pharmacokinetic/pharmacodynamic data analyses using standard industry data analysis software., • Familiar with PK/PD concepts. principles and applications to support prospective dose/regimen recommendations for planned Phase 1, 2 and 3 trials., • Experience in preparing clinical pharmacology components of clinical study protocols and clinical study reports., • Knowledge of current practices and issues in the bioanalytical and drug metabolism areas., • Proficient in the use of Microsoft Word, Excel and PowerPoint. Travel: • Ability to travel domestic and internationally ≤ 20%. Benefits: Competitive salary commensurate with experience Comprehensive benefits package, including medical, dental, and vision coverage Opportunities for career growth and professional development Collaborative and dynamic work environment with a diverse team of scientists and clinicians Opportunity to make a meaningful impact on cancer patients' lives through innovative translational research

Job DescriptionJob Title: Food Safety Quality Specialist Job Description The Food Safety Quality Specialist supports daily quality and food safety operations on the plant floor, ensuring that all processes meet regulatory, customer, and internal standards. This role maintains and updates food safety programs, partners closely with production and maintenance teams to resolve quality issues, and plays an active part in audits, inspections, and continuous improvement initiatives within a global, growth-focused organization. Responsibilities • Support daily quality and food safety operations on the plant floor, ensuring products meet internal and regulatory standards., • Assist the Supervisor Product Safety Site Leader in maintaining site compliance with all applicable food safety and quality requirements., • Maintain, review, and update Food Safety Plans in accordance with FSMA requirements., • Support the development, implementation, and ongoing maintenance of HACCP plans, standard operating procedures (SOPs), and sanitation standard operating procedures (SSOPs)., • Participate actively in food safety and quality committees, including allergen control, sanitation, and traceability teams., • Partner with Production and Maintenance to troubleshoot and resolve quality and food safety issues in a timely and effective manner., • Support equipment commissioning activities, ensuring new or modified equipment meets food safety and quality standards., • Contribute to process improvement initiatives focused on enhancing product quality, food safety, and operational efficiency., • Maintain accurate, complete, and organized records to support FDA and other regulatory compliance requirements., • Interact cross-functionally with internal stakeholders to prepare for and support internal and external audits and inspections., • Manage or support food safety programs and audits independently within a food manufacturing environment, including HACCP plans and GFSI-related standards., • Apply food microbiology and quality assurance principles to monitor and improve food safety controls.Essential Skills, • 2–3+ years of experience in food manufacturing, managing audits, HACCP plans, and food safety programs independently., • Hands-on experience with HACCP development, implementation, and assessment., • Experience working with or enforcing GFSI standards within a food manufacturing environment., • Strong background in quality assurance and food safety, including food microbiology., • Ability to maintain and update Food Safety Plans in accordance with FSMA., • Experience supporting or managing food safety audits and inspections., • PCQI certification., • HACCP certification., • Bachelor’s degree in Food Science, Food Microbiology, Microbiology, or a related field., • Ability to collaborate effectively with production, maintenance, and cross-functional teams., • Strong attention to detail and accuracy in maintaining regulatory and quality records.Additional Skills & Qualifications, • Internal auditor certificate (nice to have)., • Experience participating in allergen control, sanitation, and traceability programs., • Experience supporting equipment commissioning and process improvement initiatives in a manufacturing setting., • Strong problem-solving skills for troubleshooting quality and food safety issues., • Ability to work independently while contributing to a small, collaborative team., • Interest in contributing to a global organization focused on taste, scent, and nutrition and delivering natural solutions to customers.Work Environment This role operates primarily within a plant-based quality and food safety setting, working closely with production, maintenance, and support laboratory teams. The position is part of a small team of approximately two people and includes time in an individual cubicle as well as time in the support lab and on the plant floor. The environment involves regular interaction with manufacturing operations, equipment commissioning activities, and audit or inspection preparation. The organization is a global leader in taste, scent, and nutrition, with a strong focus on natural solutions and growth, offering a collaborative and quality-driven culture. Job Type & Location This is a Permanent position based out of Milltown, NJ. Pay and Benefits The pay range for this position is $65000.00 - $75000.00/yr. Medical, dental, and vision insurance (glassdoor.com) Health Savings Account (HSA) & Flexible Spending Account (FSA) options (glassdoor.com) Disability insurance (short/long-term) (glassdoor.com) Life insurance + AD&D coverage (glassdoor.com) Employee Assistance Program (mental health/support services) (glassdoor.com) 15 days pto, 5 sick and safety Workplace Type This is a fully onsite position in Milltown,NJ. Application Deadline This position is anticipated to close on Jun 2, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment 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 the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall 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 applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Job DescriptionObjective The Process Engineer will provide technical support for GMP drug product manufacturing operations. This role will provide technical support and conduct investigations into product/process quality events and customer complaints; identify, assess, and execute projects to optimize existing processes, raw materials, components, and packaging in manufacturing and final product packaging; work with multi-functional teams to execute and deliver assigned projects, including specification, conceptual development, protocol writing, selection, testing, and qualification. This is a hybrid role, based part-time in the office and part-time remote, with the office located in Somerset, NJ. Travel will be required to our Iowa facility. Ability to support travel 25%. Essential Functions • Identify opportunities to improve quality, efficiency, and customer service through changes to product components, component processing, and component inspection. Evaluate those opportunities and present projects to management for approval to implement changes., • Work with multi-functional teams to execute product and packaging projects to improve and optimize manufacturing and packaging processes. Support complex projects to meet established timelines without impacting manufacturing. Proactively adjust schedules to meet changing priorities., • Provide technical support for the transfer of new or improved manufacturing processes between functional groups or sites, ensuring knowledge capture and compliance with quality and regulatory standards., • Write and execute validation protocols either acting as the study director/validation engineer or working with the Validation department., • Lead and participate in investigations to drive technically and scientifically sound corrective and preventative actions. Apply creative problem-solving techniques using knowledge base and historical experience to address immediate, short-term, and future needs. Lead root-cause analysis investigations as a technical resource., • Investigate product complaints and write reports of investigations. Assist as required to support conclusion and possible corrective actions., • Provide support in the development, review, and maintenance of various radiopharmaceutical and cGMP documents, including Standard Operating Procedures (SOPs), Batch Records, Work Instructions and technical documents., • Assist in the development of training materials and conduct training sessions for target audience on document updates, providing clarity and guidance, ensuring full compliance., • Present data and information as a technical subject matter expert to regulatory agencies., • Actively promote safety. Always demonstrate good safety practices including the appropriate use of protective equipment. Report and take initiative to correct safety & environmental hazards, • Write and manage actions for change controls in Quality Management System (QMS) as applicable for tech transfers., • Stay up to date with industry regulations and guidelines (e.g., FDA, EMA) to ensure that all documentation meets regulatory requirements and contributes to regulatory submissions.Education/Experience, • Bachelor’s Degree in Engineering or related scientific discipline., • Minimum 2 years of experience in pharmaceutical or medical device manufacturing or other related regulated industry., • Expert knowledge of MS Office suite., • Previous experience working with radiopharmaceuticals and CMOs strongly preferred.Knowledge/Skill/Ability, • Must possess excellent written, verbal and presentation skills. Must be able to communicate effectively with all levels of management, both internal and external., • This individual should be a self-starter with the ability to work well both independently and in a team environment., • Demonstrated technical problem-solving skills with root cause analysis tools., • Direct experience with project management skills., • Excellent organizational and time management skills., • Establishes strong inter-departmental relationships and is viewed as a valuable technical resource to others., • Direct experience with technical transfer and aseptic/parenteral pharmaceutical process validation methodologies, • Familiar with Code of Federal Regulations (CFR) parts 210 and 211 and supporting regulatory inspections, • Experience in drafting and reviewing Chemistry, Manufacturing and Controls (CMC) regulatory filing sections, • Ability to support travel 25%.Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. During this job, the employee may encounter exposure to radiation hazards. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. For information on Perspective Therapeutics, visit our website at: www.perspectivetherapeutics.com. Perspective Therapeutics 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. Powered by JazzHR tzuk0kNJ02

Job Description SOKOL GxP Services is seeking a Production – Supply Chain Planner to support supply planning operations within a pharmaceutical manufacturing environment. This role supports both internal and external manufacturing sites and helps ensure alignment between customer demand, inventory strategy, and operational efficiency. The Supply Chain Planner will collaborate with supply sites, logistics teams, and cross-functional stakeholders to support supply continuity, manage inventory risks, and maintain accurate planning data within ERP systems. Requirements • Develop and manage supply plans for materials and product portfolios, • Coordinate with internal and external manufacturing sites to support customer demand and operational efficiency, • Maintain inventory accuracy and support purchase order management for drug substance, drug product, and finished goods, • Monitor demand changes and adjust planning activities and production schedules accordingly, • Identify and communicate supply risks, shortages, excess inventory, and operational constraints, • Support inventory investigations related to regulatory or artwork changes, • Participate in supply chain meetings and collaborate with global and local stakeholders, • Track and report key supply chain metrics including inventory compliance, PO accuracy, and backorders, • Support monthly and quarterly stock reviews, forecasting activities, and root cause analysis, • Participate in process improvement initiatives and support new product introductions and clinical supply requests, • Ensure master data is accurately maintained and continuously updated, • Utilize ERP and planning systems including SAP and related supply planning tools, • Support data analysis and reporting activities using Excel and BI platforms such as Tableau or Power BI Qualifications • Bachelor’s degree in Supply Chain Management, Engineering, Biotechnology, Science, or related field required, • Minimum 4 years of supply chain management experience, preferably within pharmaceutical or global manufacturing environments, • Strong understanding of supply chain operations, inventory management, and planning workflows, • Experience with ERP systems such as SAP; Rapid Response experience preferred, • Familiarity with pharmaceutical regulatory requirements including cGMP, FDA, and EMA environments preferred, • Strong analytical, organizational, communication, and problem-solving skills, • Ability to manage multiple priorities and work effectively under tight deadlines, • APICS or related certification preferred Benefits Competitive hourly rate: $31.50 – $34.30/hr (W-2 only, no C2C) Hybrid position - 50 % on site Working Hours: Monday - Friday, regular business hours 12-month contract with possible extension Health insurance, holiday pay, 401(k) program, and other benefits Employee referral bonus program

Job DescriptionSalary: The START Center for Cancer Research (START) is the worlds largestearly phasesite network, fully dedicated tooncologyclinical research.Throughout ourhistory, START has provided hope to cancer patients inglobalcommunity practices by offering access tocutting edgetrials throughout the US and Europe. Today, with over 1,300 studies completed, and with research facilities in the United States and in Spain, Portugal, and Ireland, STARTs mission is to accelerate the development of new anticancer drugs that will improve the quality of life and survival for patients with cancer and lead to its eventual cure. To date, over 43 therapiesconductedat STARTlocationshave obtained FDA/EMA approval.Incredibly, while Academic Medical Centers (AMCs) conduct 80% of cancer trials, such trials reach only 20% of the patient population leavingthe majority ofpatients who are treated in community practices and hospitals without access to a clinical trial when their care journey calls for one. START serves the many by bringing cancer trials to physicians and their patients in community hospitals and practices when hope is needed most. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world.As an example, in San Antonio, where START was founded, START treated the first patient ever with Keytruda the most effective cancer drug in medical history. We are seeking a Clinical Principal Investigator. The Clinical Principal Investigator (PI) is a physician-scientist responsible for the overall preparation, conduct, and management of sponsored projects, ensuring compliance with all regulatory requirements and institutional policies. This role will manage the development and execution of clinical trial protocols, contribute to data analysis, and maintain strong communication and alignment with sponsors. Essential Responsibilities • Manage early phase clinical trials by providing overarching medical direction and comprehensive medical reviews of protocols in conformance with the investigational plan and good clinical practice., • Provide medical and scientific feasibility of all new sponsor inquiries driving growth through strategic partnerships., • Lead and manage a matrix team of responsible for responsible for the conduct of early phase oncology trials., • Ensure the safety and well-being of all participants in the study at the trial site are protected., • Ensure data collected at the study site is credible and accurate., • Ensure the rights, integrity, and confidentiality of all participants in the trial at the site are protected., • Develop close personal working relationships with Sponsors and Clinical Research Organizations involved in study conduct., • Provide expert guidance and support to clinical operations research staff and sponsor client., • Lead continuous quality improvement efforts for clinical research services, integrating best practices and fostering a culture of research excellence., • Develop and implement strategies to enhance patient recruitment and retention in clinical trials. Required Education and Experience: • M.D. or equivalent., • Board Certified in Hematology and/or Medical Oncology., • Clinical trials experience with a strong interest in drug development., • Ability to critically analyze clinical scientific data and literature., • Understanding of GCP principles, safety and adverse event reporting, FDA regulations, and biomedical research ethics., • A passion for providing excellent clinical care and for working in a collaborative / team-oriented environment. Preferred Education and Experience: • Previous experience with industry sponsored clinical trials., • Excellent communication skills, with experience in publishing and presenting at scientific meetings., • Translational research experience and familiarity with pharmacokinetics and pharmacodynamics. More aboutTheSTART Center for Cancer Research Deeply rooted in community oncology centers globally, The START Center for Cancer Research provides access to specialized preclinical and early-phase clinical trials of novel anti-cancer agents. START clinical trial sites have conducted more than a thousand early-phase clinical trials,including for43 therapies that were approved by the FDA. STARTrepresentsthe worlds largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. Learn more atSTARTresearch.com. Ready to be part of a team changing the future of cancer treatment? Join us in our mission to conquer cancer, one clinical trial at a time. Yourexpertiseand dedication can help us bring hope and healing to patients worldwide.Pleasesubmityour application online. We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Job Description Job Description Date 02/2024 Location 1300 Airport Road, North Brunswick NJ Title Lead, Quality Control Chemist Department Quality Control Reports to Manager, Quality Control Laboratory FLSA (Exempt or Non-Exempt Exempt Role Overview The Lead, QC Chemist performs specific routine analysis of samples of raw materials, in process, and finished products according to established (official and/or in-house) test procedures. Testing assesses the strength, identify, purity of the test samples and/or raw materials. The Chemist prepares reagents, standards, and solutions and may monitor and verify quality in accordance with statistical process and other control procedures. The Chemist maintains & organizes testing’s and compliance while working in a fast-paced environment with changing priorities. The duties and responsibilities described for each level 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. Management reserves the right to modify, assign, or reassign duties and responsibilities at any time based on business needs. Areas of Responsibility • Performs assigned sampling, physical, chemical tests and assay on raw materials, active dietary ingredients, in-process, finished, and stability products in an FDA regulated lab environment. Uses a variety of wet chemicals, physical and instrumental techniques as well as routine QC instruments HPLC, GC, IR, Auto Titrator, Bulk Density, UV Spectrophotometer, Dissolution, Karl Fisher (KF), Potentiometer., • Troubleshoots HPLC, GC, QC instruments for specific tests in order to assist in determining the root cause of aberrant results and help in performing Lab investigations / OOS., • Evaluates daily raw data sheets for product samples and release, if needed., • Coordinates annual review of STPS / SOPS as per USPL procedures., • Prepare new methods and test procedures for new or existing raw materials and finished products., • Ensures compliance with company and customer specifications as well as federal, state and local regulatory requirements., • Perform floor supervision of QC Chemists for routine testing, if required., • Prepares and reviews QC related documents during and finishing of testing of sample. Submit all testing related documents like data sheets, chromatograms, spectras, instruments print outs in timely manner to Qc Documentation department to release the batch of raw material / finished product., • Prepares and/or Reviews Test Procedures, SOP's and Protocols as assigned., • Performs maintenance and calibrations of laboratory instruments /equipment, if required to help in-house calibrations., • Assures GMP compliance according to FDA CFR Part 111 and USPL SOPs / guidelines., • Complies with all regulatory/ in-house requirements (may include but not be limited to safety, housekeeping, laboratory chemical waste, cGMP, GLP, documentation) when performing the assigned activity., • Trains new QC Chemists to perform instrumental testing., • Must be able to work extended hours as needed and occasional weekends., • Other duties and responsibilities as assigned by QC in-charge / management. 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: • BS/MS in Chemistry or related scientific disciplines., • Five (5) years of basic chemistry techniques (can be academic) is a plus., • Minimum of 5 years QC lab work experience in handling HPLC, GC, KF, Dissolution, DT and other sophisticated lab instruments in dietary supplements, food or OTC / Pharmaceutical manufacturing industry. Certifications, Licenses, Credentials: • N/A Skills & Ability • Ability to maintain integrity and honesty at all times and to communicate with transparency., • Ability to work independently or as part of a team., • Solid understanding of cGMP’s and GLP and is familiar with 21 CFR Part 11., • Strong working knowledge of Microsoft Word, Excel., • Good documentation practices and able to write simple, clear reports., • Meets commitments on time and practices time-management skills., • Seeks to identify continuous improvement needs., • Experience with Shimadzu LC2010, Nexera, GC2010, Thermo ICP-MS, Labsolution and Waters, • Empower Lab Software a plus. Physical Requirements (lifting, etc.): • Ability to navigate office, lab, and/or plant floor working environments., • 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 and leaning 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., • On occasion may need to lift up to 20lbs 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., • May execute up to 20% of their work at the bench level either standing or sitting on a stool., • Work performed in a standard office environment is without unpleasant or hazardous conditions. 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.

Job DescriptionAbout GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology. Job Title: Customs Trade Compliance Expert This position is based fully fully remote. The salary range is approximately $85,000 - $105,000 based on experience. Responsibilities: • Ensure adherence to all applicable import/export and PGA requirement and regulations, including CFR, HTSUS, U.S. Export Administration Regulations (EAR), International Traffic in Arms Regulations (ITAR), and other international trade laws., • Act as the primary point of contact for customs clearance processes., • File entries through the Automated Broker Interface (ABI) in compliance with CBP regulations., • Supervise classification processes for Harmonized Tariff Schedule (HTS), Schedule B, ECCN, and Harmonized System Codes (HSC) to ensure compliant imports/exports and maximize duty savings., • Establish and lead Duty Drawback Program., • Apply and maintain company Import and Export Licenses and Permits., • Interpret import/export regulations, rulings, and trade documentation., • Conduct compliance audits to ensure full regulatory compliant with accurate filings and duties, and lead corrective action plans resulting from audits and compliance issues., • Coordinate release and delivery of shipments with customs, freight forwarders, carriers, and warehouses., • Address any customs-related issues such as holds, inspections, and compliance reviews., • Maintain required documentation for audit readiness and CBP recordkeeping requirements (19 CFR)., • Collaborate with internal and external teams to provide customs guidance and operational support., • Stay current with regulatory changes from CBP and Partner Government Agencies (PGA) such as FDA, USDA, EPA, FWS, CDC and more., • Train and support team members in customs procedures, filing practices, and import/export compliance., • Stay updated on changes to import/export laws and regulations in countries where the company operates., • Identify and address risks related to trade compliance, including restricted-party transactions and violations of trade law., • Investigate and report trade compliance incidents, and implement corrective actions. Requirements: • U.S. Customs Broker License or CCS or CES certified with Duty Drawback program setup experience, • Minimum 5+ years of experience in trade compliance with special focus in duty drawback, • Solid knowledge of Import/Export Regulations and Product Classification., • Proven expertise in U.S. import/export procedures and regulatory environments., • Strong working knowledge of ACE, ABI systems, and classification tools., • Excellent attention to detail, accuracy, and time management., • Ability to communicate professionally with clients, vendors, and government agencies., • Proficiency in MS Office Suite and customs brokerage software (e.g., Mercury/ITS, CargoWise, Descartes, etc.). Preferred Qualifications: • Ability and success tracking records of establishing and maintaining a successful Duty Drawback program, • Experience of filing import entries using ABI-approved vendor portal., • Background in customs audits or post-entry corrections (e.g., PSC, protests). #LI-EB1 #GS 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 WSAudiology is a global leader in the hearing aid industry. Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world. Part of WSAudiology group, HearUSA is on a mission to reframe the world of hearing care and set the highest standard in modern hearing health. With an extensive network of 4,000 independent Hearing Care Professionals and more than 350 centers in U.S., we strive every day to provide each individual with the care, knowledge and experience they deserve. ESSENTIAL DUTIES AND RESPONSIBILITIES: Perform comprehensive hearing evaluation, hearing aid selection and fitting for all clients, employing best practices as defined by our client-centric service model of Simply Excellent Hearing Care. Meets minimum NPS score of 75. Routinely demonstrates hearing aids as part of annual evaluations for clients to experience the sound and create the ‘wow’ moment of a personalized auditory simulation. Evaluate test results in conjunction with client needs' assessment to make a personalized recommendation. Offers recommendation based on maximizing client benefits. Perform routine follow-ups, clean and checks and hearing aid repairs. Maintain skills in ear impression taking, earmold modification and recommendation of ALD accessories. Embody HearUSA's ambition of Changing Lives through Simply Excellent Hearing Care. Partner with the District manager, HCP Team Leads and L&D to adopt new initiatives aimed to grow your Center's revenue and change more lives. Build a local community to proactively generate service demand and support marketing campaigns, such as to physicians and at health fairs. Successfully completes one community outreach and/or physician marketing per quarter. Comply with all State license laws, FDA guidelines, WSA policies and HearUSA Quality Practice Guidelines (QPG). Operates in a HIPAA compliant manner, with documentation, outcome notes and referrals completed for all clients. Engage in Continued Professional Development to maintain expertise in all aspects of service delivery, from consultative counseling to the selling, fitting and troubleshooting of current hearing aid technology. Embraces our culture and values of Going Beyond Together, Pioneering for Better Solutions, and Passion for Impact. REQUIREMENTS: Experience in a similar Audiology or Hearing Aid Specialist role. Active state license in Audiology and/or hearing aid dispensing. 1-5 years of experience preferred. Ability to pay close attention to detail with a high degree of accuracy. Basic or advanced written communication skills. Experience interacting with customers/clients. Ability to communicate detailed or technical information clearly, accurately and concisely. Ability to work quickly, accurately and independently in a fast paced environment. A PLACE TO GROW YOUR CAREER: Growth means investing in employee development, from day-to-day support to opportunities to stretch your skills. It also means creating space for your voice, sharing knowledge, and learning from peers as we build culture and community together. You will benefit from: A structure of field support for your hearing center A professional development team of dedicated Regional Training Managers Continuing education, LinkedIn Learning & licensing reimbursement Career advancement pathways such as Hearing Care Provider and Client Experience Specialist Team Lead, Hearing Care Provider Advisory Board member, or District Manager Paid externships and a Hearing Instrument Specialist Trainee program THE SUPPORT OF A LEADER IN HEARING HEALTH: HearUSA accepts the most insurance plans in the industry, has extensive network coverage, advanced online services, and pioneering technology. We draw on the expertise and hearing care services of more than 360 hearing centers across the U.S. HearUSA is also part of the WS Audiology (WSA) family, a global leader with over 11,000 employees in 125 markets and 2 global headquarters. AS A LEADER WE CAN OFFER: Monthly Commissions CEUs & State Licensure Renewals for HCPs Defined Career Paths Sponsorship & Preceptor Opportunities President’s Club Incentives Employee Referral Program LIFESTYLE & BENEFITS: Comprehensive Benefits Package Paid Holidays & PTO Policy 401k Matching Program Tuition Reimbursement Employee, Family & Friends Hearing Aid Discount Program Service Days & Diversity, Equity & Inclusion Initiatives Salary: $55,000 - $75,000 The Company provides equal opportunity to all employees and prospective employees without regard to race, color, creed, religion, national origin, ancestry, sex, age, physical or mental disability, marital status, pregnancy, genetic information, sexual orientation, gender identity, protected veteran or military status, or any other consideration not related to the person’s ability to do the job or otherwise made unlawful by federal, state, or local law.

Job Description About Spectrum Vascular Spectrum Vascular is an innovative medical device company focused on vascular access and medication management. Our mission is to improve the lives of patients worldwide by providing caregivers with high quality, innovative products with exceptional customer service. We are a company that was formed through the acquisition of a portfolio of trusted products that have been widely used by customers for decades. Innovation has been a core strategic pillar throughout our history and many of our products have been designed to deliver antimicrobial and antithrombogenic protection or to support certain patient populations such as those who are critically ill and pediatrics. This role represents a unique opportunity to join a dynamic and growing team with established products and an entrepreneurial mindset. Role Description: The Director, Regulatory Affairs is responsible for leading and executing regulatory activities to support global product registrations and lifecycle compliance for the company's medical device portfolio. This role combines strategic oversight with hands-on regulatory execution, including direct authorship of complex submissions (e.g., 510(k)s), regulatory assessments, and agency interactions. This individual serves as a key regulatory lead within cross-functional teams and is accountable for ensuring that regulatory requirements are effectively translated into actionable plans and deliverables across the product lifecycle. Key Responsibilities • Serve as the regulatory lead for product development and lifecycle management, providing both strategic direction and hands-on execution of regulatory deliverables., • Author, review, and finalize regulatory submissions (e.g., 510(k), PMA, international dossiers), ensuring high-quality, technically sound, and compliant submissions., • Lead preparation and management of U.S. FDA and global regulatory submissions, including direct interaction with regulatory authorities and notified bodies., • Drive regulatory strategy development for new products, product changes, and global market expansion, while ensuring alignment with business objectives., • Act as the primary regulatory representative on cross-functional teams, influencing decisions related to product design, claims, testing, and labeling., • Evaluate and interpret regulatory requirements, guidance documents, and regulatory intelligence, translating them into actionable plans., • Provide expert regulatory input into design control, risk management (ISO 14971), clinical, and preclinical activities to support submissions and compliance., • Assess the regulatory impact of product and process changes, and define appropriate submission strategies or justification for non-submission., • Lead and support regulatory agency interactions, including pre-submissions, deficiency responses, and meeting preparation., • Ensure timely responses to regulatory inquiries and manage commitments to regulatory bodies., • Oversee and contribute to labeling and promotional material review to ensure compliance with applicable regulations and approved claims., • Provide regulatory leadership in quality system activities, including CAPAs, nonconformances, field actions, and change control., • Support and participate in audits and inspections (FDA, Notified Bodies), including preparation and response activities., • Mentor and provide guidance to junior regulatory staff, while remaining actively engaged in execution., • Contribute to the development and continuous improvement of regulatory processes, SOPs, and internal best practices. Competencies • Demonstrated ability to operate at both strategic and tactical levels, with strong execution focus, • Deep technical expertise with the ability to independently author complex regulatory submissions, • Strong analytical and problem-solving skills, with the ability to navigate ambiguous regulatory pathways, • Effective communicator with the ability to influence cross-functional stakeholders and senior leadership, • High attention to detail with a consistent focus on quality and compliance, • Ability to manage multiple priorities and adapt in a fast-paced, evolving regulatory environment, • Proven leadership capability, including mentoring and guiding team members Qualifications • Bachelor's degree (B.S. or B.A.) in Engineering, Life Sciences, or related field required, • 8–10+ years of regulatory affairs experience in an FDA-regulated industry (medical device preferred), • Demonstrated hands-on experience authoring and leading 510(k) submissions, • Strong knowledge of FDA regulations, global regulatory frameworks, and medical device requirements, • Experience interacting directly with FDA and Notified Bodies, • Solid understanding of design controls, product development, and lifecycle management, • Advanced degree preferred Work Environment: · Dynamic, interactive, fast-paced, and entrepreneurial environment · Travel – up to 25%??, additional may be required during execution of validation activities Spectrum Vascular is an Equal Opportunity Employer and committed to creating a diverse and inclusive company culture. Spectrum Vascular does not discriminate against candidates and employees because of their disability, sex, race, gender identity, sexual orientation, religion, national origin, age, veteran status, or any other protected status under the law.

Job Description Onsite Women's Health is on a mission to improve women's healthcare. In partnership with forward-thinking providers across the country, Onsite Women's Health offers comprehensive mammography services with clinical expertise, innovative technology, and proprietary protocols that delivers personalized, convenient breast care for the patient. Convenience drives compliance, and compliance saves lives.Convenience is critical to ensure that most women have time to remain compliant with their breast care. By offering mammography and breast care within the patient's primary care or OB/GYN practice and scheduling appointments in coordination with an annual exam, compliance is easier to accomplish. The Opportunity The OWH program is unparalleled, making breast cancer screening more convenient for women. Up $5000 Sign On Bonus! Are you tired of working weekends? Do you want a Mon - Fri work schedule? Do you like to work independently and have ownership of all aspects of patient-centric care? See yourself here. At Onsite we don't work weekends and offer the opportunity to use the latest 3D tomosynthesis digital mammography equipment in an OB/Gyn office environment. If you are an experienced mammographer, someone who can work independently and wants to have an impact on each and every patient, join us! What do you need to be the right candidate for this role? • Must be up to date on all CME credits., • Must be very patient centric, compassionate, and computer savvy., • Able to perform a variety of technical activities associated with the performance of screening and diagnostic mammography procedures., • Flexible with the ability to multi-task., • Willing to work a flexible part time schedule. What are your responsibilities? • Specializes in the production of screening and diagnostic mammograms for the detection of breast cancers and lesions., • Responsible for the initial and ongoing success of the mammography service in the practice in which one works., • Assist practice in any and all ways possible to be sure all eligible age-appropriate patients have annual screening mammograms., • Prepares patients for the mammographic procedure., • Explains procedures to the patient to reduce anxieties and obtain patient cooperation., • Moves mammographic equipment to specific positions and adjusts controls to set exposure factors based on knowledge of radiographic exposure techniques and protocols., • Practices radiation protection techniques by using beam restrictive devices, patient shielding skills., • Follows prescribed safety standards in operating all required equipment., • Examines digital images for image quality., • Ensures equipment is in proper working order at all times., • Performs all required QA testing required to comply with MQSA, ACR and State requirements/regulations., • Maintains patient confidentiality at all times., • Processes routine paperwork and all required data entry., • Participates in professional development activities and maintains professional affiliations., • Prepares all required reports and data pursuant to MQSA and State requirements., • Assists the Radiologist with QA/QC reporting., • Performs all mammography tracking following MQSA guidelines and requirements., • Maintains all QA documents necessary to exceed Annual FDA Inspection requirements., • Is responsible for obtaining and maintaining ACR accreditation. Exceptional compensation for the right candidate and competitive benefits. Experience: • Mammography: 2 years (Required) License: • ARRT (Required) EOE M/F/V/H

Job Description PER DIEM OPPORTUNITIES AVAILABLE Onsite Women's Health is on a mission to improve women's healthcare. In partnership with forward-thinking providers across the country, Onsite Women's Health offers comprehensive mammography services with clinical expertise, innovative technology, and proprietary protocols that delivers personalized, convenient breast care for the patient. Convenience drives compliance, and compliance saves lives.Convenience is critical to ensure that most women have time to remain compliant with their breast care. By offering mammography and breast care within the patient's primary care or OB/GYN practice and scheduling appointments in coordination with an annual exam, compliance is easier to accomplish. The Opportunity The OWH program is unparalleled, making breast cancer screening more convenient for women. Do you want a flexible work schedule? Can you be available to cover on a moment's notice? Do you want to experience different office environments? Then come to Onsite Women's Health as a Per Diem Technologist! See yourself here. At Onsite we don't work weekends or after hours and offer the opportunity to use the latest 3D tomosynthesis digital mammography equipment in an OB/Gyn office environment. If you are an experienced mammographer, someone who can work independently and wants to have an impact on each and every patient, join us as a Per Diem. What do you need to be the right candidate for this role? • Must be up to date on all CME credits., • Must be very patient centric, compassionate, and computer savvy., • Able to perform a variety of technical activities associated with the performance of screening and diagnostic mammography procedures., • Flexible with the ability to multi-task., • Willing to cover on a moment's notice. What are your responsibilities? • Specializes in the production of screening and diagnostic mammograms for the detection of breast cancers and lesions., • Responsible for the initial and ongoing success of the mammography service in the practice in which one works. Assist practice in any and all ways possible to be sure all eligible age-appropriate patients have annual screening mammograms., • Prepares patients for the mammographic procedure., • Explains procedures to the patient to reduce anxieties and obtain patient cooperation., • Moves mammographic equipment to specific positions and adjusts controls to set exposure factors based on knowledge of radiographic exposure techniques and protocols., • Practices radiation protection techniques by using beam restrictive devices, patient shielding skills., • Follows prescribed safety standards in operating all required equipment., • Examines digital images for image quality., • Ensures equipment is in proper working order at all times., • Performs all required QA testing required to comply with MQSA, ACR and State requirements/regulations., • Maintains patient confidentiality at all times., • Processes routine paperwork and all required data entry., • Participates in professional development activities and maintains professional affiliations., • Prepares all required reports and data pursuant to MQSA and State requirements., • Assists the Radiologist with QA/QC reporting., • Performs all mammography tracking following MQSA guidelines and requirements., • Maintains all QA documents necessary to exceed Annual FDA Inspection requirements., • Is responsible for obtaining and maintaining ACR accreditation. Exceptional compensation for the right candidate! Experience: • Mammography: 2 years (Required) License: • ARRT (Required) EOE M/F/V/H

Job DescriptionJob Summary: A hands-on scientific position evaluating, designing, and executing robust scaleable formulation development plans. The position will focus on enabling delivery and absorption of drugs and complex molecules via oral, transdermal, and topical routes. Also, the position will function as a key member of the team responsible for evaluation and execution of study plans to drive the development of new or alternative technologies and innovations. Responsibilities: • Responsible for design, execution, and analysis of formulation strategies in support of product development, product characterization and process optimization relating to Aquestive’s pharmaceutical business., • Designs and optimizes formulations to achieve drug product properties for controlled delivery of drugs (i.e. oral, transmucosal, and topical) ., • Designs, prepares, and characterizes laboratory prototype samples for in vitro, ex-vivo, and in vivo evaluation., • Evaluates and vets new and emerging technologies to drive innovative drug delivery., • Serves as an Aquestive SME for new product/technology opportunities, collaborating cross-functionally with internal and external stakeholders., • Responsible for developing robust formulations and processing conditions for the successful scale up to commercial equipment., • Authors and executes manufacturing batch records for GMP manufacture of Phase I clinical supplies., • Authors technical reports and procedures for experimental studies and in support of regulatory activities. Provides technical support for technology transfer, CMC documentation, and manufacturing readiness., • Mentors junior scientists in formulation techniques, experimental design, and data analysis., • Maintains rigorous scientific practices, data integrity, and laboratory compliance within internal standards., • Performs other duties as deemed necessary to support laboratory operations. Qualifications: • MS or PhD (preferred) degree in a relevant scientific discipline with 5-10 years' experience in pharmaceutical development., • Experience in alternate delivery of drugs (oral, transmucosal, topical) preferred, • Strong background in formulation design, optimization, and characterization, • Hands-on expertise with experimental design, data analysis, and statistical tools., • Excellent technical writing skills for preparing reports and presentations., • Good understanding of formulation development principles, DoE/QbD and FDA/CMC/ICH guidelines are required, • Regulatory document authoring experience is required, • Must have an ability to work on multidisciplinary teams to drive innovation that leads to commercially viable products/technologies., • Proficiency in standard office software (MS Word, Excel, PowerPoint) and statistical analysis tools (i.e. JMP)., • Must be detail oriented, organized, and suited to work in a dynamic fast-paced 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. 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. Expected Base salary range: $115,000.00 to $125,000.00 USD

Job Description Date 06/2020 Location 1200 Airport Road, North Brunswick NJ Title Chemist, Quality Control 3 Department Quality Control Reports to Manager, Chemistry Laboratory FLSA (Exempt or Non-Exempt Exempt Role Overview The Chemist, QC 3 performs specific routine analysis of samples of raw materials, in process, and finished products according to established (official and/or in-house) test procedures. Testing assesses the strength, identify, purity of the test samples and/or raw materials. The Chemist prepares reagents, standards, and solutions and may monitor and verify quality in accordance with statistical process and other control procedures. The Chemist maintains organization and compliance while working in a fast-paced environment with changing priorities. The duties and responsibilities described for each level 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. Management reserves the right to modify, assign, or reassign duties and responsibilities at any time based on business needs. Areas of Responsibility • Troubleshoot /test specific batches in order to assist in determining the root cause of off-spec product and makes recommendations for ingredient adjustments to meet required specifications., • Ensures compliance with company and customer specifications as well as federal, state and local regulatory requirements, • Investigates customer complaints and provides management with test results information., • Performs assigned sampling, physical, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished, and stability products in an FDA regulated lab environment. Uses a variety of wet chemicals, physical and instrumental techniques as well as routine QC instruments (HPLC, GC, IR, Auto Titrator, Bulk Density, UV Spectrophotometer, Dissolution, Karl Fisher (KF), Potentiometer)., • Performs complicated testing with supervisory direction. Documents work clearly and performs tests accurately., • Preparation and review of QC related documents is 5%of daily activities., • Test of samples/raws as assigned and reports the results. Testing activities represents 95% of daily work., • Prepares and/or Reviews Test Procedures, SOP's and Protocols as assigned., • Performs maintenance and calibrations of laboratory instruments /equipment with supervisory direction/training., • Complies with all regulatory/ in-house requirements (may include but not be limited to safety, housekeeping, laboratory chemical waste, cGMP,GLP, documentation) when performing the assigned activity., • Must be able to work extended hours as needed and occasional weekends., • Other duties and responsibilities 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: • BS in Chemistry or related scientific disciplines, • One (1) year of basic chemistry techniques (can be academic) is a plus, • Minimum of 1 -3 years QC lab work experience with industry experience in dietary supplements, food, or OTC manufacturing. Certifications, Licenses, Credentials: • N/A Skills & Ability • Ability to maintain integrity and honesty at all times and to communicate with transparency., • Ability to work independently or as part of a team., • Solid understanding of cGMP’s and GLP and is familiar with 21 CFR Part 11, • Strong working knowledge of Microsoft Word, Excel., • Good documentation practices and able to write simple, clear reports, • Meets commitments on time and practices time-management skills, • Seeks to identify continuous improvement needs, • Experience with Shimadzu LC2010, Nexera, GC2010, Thermo ICP-MS, Labsolution and Waters Empower Lab Software a plus. Physical Requirements (lifting, etc.): • May execute 90%-100% of their work at the bench level either standing or sitting on a stool., • 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 and leaning 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., • On occasion may need to lift up to 35 lbs., • Ability to navigate office, lab, and/or plant floor working environments. Work Environment (Office, Warehouse, temperature extremes, etc.): • Approximately 80% of work performed in a laboratory environment which may have unpleasant odors or hazardous conditions., • 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. 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.

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. 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.

Job DescriptionSalary: $45-55/hr. Job Title:Laboratory Relocation Project Manager Job Type: 6-monthContract; ~ 40hrs/week Location: New Brunswick, NJ About the Role: Do you have strongproject management and lab relocationskills? You will be the go-to person on-site, supporting lab moves from planning through execution, and ensuring every detail runs smoothly. As the single on-site point of contact, you will coordinate timelines and logistics, liaise with vendors and stakeholders, and manage accurate asset inventory, tagging, and labeling throughout the relocation. You will help ensure compliance with regulatory, OSHA, FDA, and GMP requirements and draw on 2 to 5 years of project coordination experience and strong communication skills. About The Company: MustardSeed PMO designs and delivers project management solutions for complex, regulated sectors. We build PMOs, plan, staff, and run projects and programs, and provide seasoned project managers on demand. Headquartered in West Chester, Pennsylvania, we serve U.S. companies with a fully U.S.-based, distributed team. Were known for fast, structured onboarding that plugs in quickly and builds momentum. Our frameworks improve communication, control, and execution to drive better decisions and measurable results. We support clients across life sciences, aerospace, food, tech, and financial services aligning PM discipline to each organizations stage. Key Responsibilities: • On-Site Coordination:Serve as the primary point of contact during laboratory relocations, ensuring projects stay on schedule and within scope., • Project Planning & Logistics:Assist in the development of relocation plans, including timelines, resource allocation, and risk management., • Asset Inventory, Tagging and Labelling:Responsibility to conduct accurate asset inventories matching customer asset registers against physical assets in the lab, creating gaps analysis and tagging/labelling assets for the move to the new location., • Customer Liaison:Serve as the single POC on site for the customer, supporting by answering questions, providing information, directing updates where needed and managing our relationship directly with end users and key stakeholders., • Vendor & Stakeholder Management:Liaise with third-party vendors, internal teams, and client stakeholders to facilitate smooth transitions., • Compliance & Safety:Ensure regulatory compliance (OSHA, FDA, GMP) is maintained throughout the move., • Issue Resolution:Identify and mitigate relocation risks, troubleshoot logistical issues, and escalate challenges as needed., • Documentation & Reporting:Maintain accurate records of project progress, relocation schedules, and vendor interactions. Qualifications & Experience: • 2-5 years of project coordination or project management experience (preferably in life sciences, or laboratory operations)., • Experience in laboratory relocations, facilities management, or supply chain/logistics is a plus., • Strong understanding of project management principles (PMP certification is a plus but not required)., • Excellent communication and stakeholder management skills to interact with researchers, lab managers, and vendors., • Proficiency in Microsoft Project, Smartsheet, or other PM tools is a plus., • A can do customer centric attitude along with being able to think and pivot quickly using your own initiative., • The ability to work in pressurized situations and environments. Additional Information: This is a 1099 contract position. MustardSeed PMO provides equal opportunity for all and prohibits discrimination and harassment of any kind.

Job DescriptionBenefits/Perks • Highly enriched & healthy work environment, • Excellent growth opportunities, • Competitive Pay, • Career AdvancementJob Summary We 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 lifecyclefrom 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 JRSs 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 • Bachelors degree in Life Sciences, Pharmacy, Biotechnology, Chemistry, or related field., • 25 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 (28C, -20C, 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 DescriptionJob Description We are seeking an experienced Import Customs Clearance Specialist to file customs entries in full compliance with U.S. Customs and Partner Government Agency regulations. The ideal candidate will have strong attention to detail, excellent communication skills, and hands-on experience handling customs entries and import documentation in a fast-paced environment. Key Responsibilities · Prepare, review, and submit import customs entries to U.S. Customs and Border Protection (CBP) · Coordinate filings with Partner Government Agencies (FDA, USDA, EPA, Fish & Wildlife Service, etc.) · Transmit customs entries accurately and within regulatory deadlines · Review commercial invoices, packing lists, bills of lading, and related documents for accuracy and compliance · File Importer Security Filings (ISF) and monitor compliance timelines · Receive, review, and process import documentation for assigned accounts · Track and trace shipment documentation (HBLs, invoices, supporting records) · Communicate with customers, overseas agents, freight forwarders, carriers, steamship lines, airlines, trucking companies, and government officials · Resolve customs-related issues including documentation discrepancies, customs exams, FDA holds, and clearance delays · Provide timely updates to internal teams and external customers · Deliver excellent customer service while maintaining compliance with all applicable laws and regulations. Qualifications & Experience · 2–5 years of experience in import customs clearance or international trade operations · Strong knowledge of U.S. Customs regulations and the Harmonized Tariff Schedule (HTS) · Familiarity with Partner Government Agencies (FDA, USDA, EPA, FWS) is a plus · Ability to work independently, multitask, and thrive in a fast-paced environment · Strong problem-solving skills and attention to detail · Excellent written and verbal communication skills · Proficiency in Microsoft Outlook, Excel, Word, and Cargowise (CW1) · Team-oriented, customer-focused mindset. Compensation & Benefits Competitive salary of $55,000–$65,000 annually, based on experience. Opportunities for professional growth and development

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