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Job DescriptionQuality Control Microbiology Engineer III Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. The Quality Control Microbiology Engineer III will support two local sites. Serving as a support role to clinical and/or commercial production. The QC Microbiology Engineer III will coordinate data for batch release, participate in project/client meetings, and author/revise microbiological testing procedures. Additionally, the incumbent will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of Microbiology, responsibilities of the • Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Coordinates microbiological testing data for batch release, • Participation in project/client meetings and communications, providing scientific and technical expertise, • Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols, • Review of investigations and documentation of non-confirming events and environmental excursions., • Apply expertise of compliance requirements to maintain an inspection-ready state., • Participate and act as subject matter expert during audits/inspections, • Develop and train QC Microbiology Engineer II on relevant business processes, • Processing of purchase orders for outsourced testing and lab supplies, • Coordinates work orders, • Other duties as assignedREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience, • Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry, • Minimum required training; GxP/GDP Training, Safety Training, • Proficient with computer software such as; Microsoft Office, MODA/LIMS; Microsoft Visio (preferred); Netsuite (preferred); Maximo Asset Management System (preferred), • Proficient knowledge of ISO and EU standards, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review., • Strong written and oral communication skills, • Strong technical writing skills, • Technical training experienceMust be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilitiesSupervisory Responsibility; Direct reportsWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels.Must have the ability to work in a team-oriented environment and with clients.Must be able to work during the weekend, holidays and as required by the company.Working EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy.Must have the ability to work in a team-oriented environment and with clientsMust be able to work during the weekend, holidays and as required by the companyMust be able to handle the standard/moderate noise of the manufacturing facility 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.

Job DescriptionJob Title: QC Microbiology Compliance InvestigatorJob Description As a QC Microbiology Compliance Investigator, you will play a pivotal role in determining the causes and preventative actions of Deviations, Non-Conformances, Out of Specifications (OOS), Out of Trends (OOT), and environmental excursion investigations. You will drive investigations to their true root cause using appropriate tools, benchmark industry standards, and implement investigative and impact assessment toolsets. Your work will define and implement effective preventative actions to prevent recurrence while managing multiple investigations efficiently. Responsibilities • Collaborate with cross-functional teams to develop and track CAPA plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Effectively utilize change management approaches., • Develop materials to train personnel on writing problem statements and using root cause analysis tools., • Manage CAPA plans and their implementation., • Communicate plans for ongoing deviations and CAPAs effectively., • Oversee the timely completion of deviations, CAPAs, and Change Controls., • Expertise in laboratory processes, CAPA, Bioburden, and Aseptic techniques., • Experience in investigations and analysis, including life-cycle investigations of deviations and non-conformances., • GMP Training, Quality Systems Training, and Safety Training., • Experience with QC Micro deviations and compliance in microbiology., • Bachelor of Science in a Quality/Process-related field or equivalent experience., • 3-5 years of experience in quality control or assurance within the bio-pharma, biologics, or pharmaceutical industry., • Experience leading event investigations, Root Cause Analysis (RCA), and CAPA., • Technical experience in writing and assessing deviations, investigations, and OOS., • Strong IT skills, including proficiency with Visio, Microsoft Project, and Excel. You will work in a GMP Commercial Facility with a schedule of Monday to Friday on the 1st shift. Flexibility is essential. The work environment offers a great atmosphere, opportunities for growth, and the chance to be part of a new project taking a client's product commercial. Job Type & Location This is a Contract to Hire position based out of Allendale, New Jersey. Pay and Benefits The pay range for this position is $45.55 - $45.55/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Allendale,NJ. Application Deadline This position is anticipated to close on Sep 30, 2025. 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 due to a disability, please email for other accommodation options.

Job DescriptionFood Manufacturing Company Urgently Hiring Machine Operators to Start ASAP on 1st and 2nd Shifts Machine Operator experience in food & beverage, nutraceutical, pharmaceutical manufacturing experience preferred. Location: Elmwood Park, NJ Pay: $24/hour ; Overtime: $30-$36/hour Shift: 1st: 6am-2:30pm (Monday-Friday) 2nd: 2pm-10:30pm (Monday-Friday) Job Description As a Production Lead, you will be responsible for leading and coordinating daily deboxing activities to support scheduled production runs and ensure timely starts. This role requires ensuring raw materials are properly deboxed, labeled, staged, and transferred for mixing promptly and accurately. You will conduct pre-op and mid-shift checks to confirm compliance with food safety, GMP, and sanitation standards, and oversee team tasks to meet production targets and maintain workflow efficiency. Responsibilities • Lead and coordinate daily deboxing activities to support scheduled production runs and ensure on-time starts., • Ensure raw materials are properly deboxed, labeled, staged, and transferred for mixing in a timely and accurate manner., • Conduct pre-op and mid-shift checks to confirm compliance with food safety, GMP, and sanitation standards., • Assign and oversee team tasks to meet production targets and maintain workflow efficiency., • Support onboarding and training of new associates while reinforcing SOPs, GMPs, and safety protocols., • Communicate regularly with warehouse, QA, mixing, maintenance, and inventory teams to minimize delays and resolve issues., • Perform basic troubleshooting and escalate equipment or inventory concerns as needed., • Monitor product quality, review documentation, and partner with QA to address any issues., • Maintain a clean, organized work environment and ensure proper cleaning of equipment during changeovers or contamination events., • Strong understanding of food safety, GMPs, and allergen handling protocols., • Minimum 1-2 years of food manufacturing or warehouse experience; leadership experience preferred., • Ability to lift 50 lbs., stand for long periods, and work in cold environments., • Bilingual (Fluent in English & Spanish) must be able to read and write in English., • High school diploma or equivalent; additional technical or vocational training preferred., • Comprehension of basic math and units of measure., • Ability to operate scales., • Strong attention to detail., • Good time management skills., • Capacity to utilize logical steps to troubleshoot equipment and process problems., • Basic computer skills, including proficiency with Microsoft Office Suite., • Strong leadership and supervisory skills., • Ability to work in a fast-paced, dynamic environment. The pay range for this position is $23.00 - $24.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Elmwood Park,NJ. Application Deadline This position is anticipated to close on Sep 26, 2025. About Aerotek: We know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meets their goals, skills and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role solving for companies’ construction, manufacturing and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are everything spirit to the test as your career continues to grow. Aerotek offers weekly pay, employee benefits including medical, dental & vision, life insurance, health advocacy and employee assistance programs, a 401(k) plan, and employee discounts. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. Company DescriptionWe know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meet their goals, skills, and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role in solving companies’ construction, manufacturing, and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are-everything spirit to the test as your career continues to grow.We know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meet their goals, skills, and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role in solving companies’ construction, manufacturing, and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are-everything spirit to the test as your career continues to grow.

Job Description Ingenus Pharmaceuticals offers a generous Paid Time Off policy, as well as, 14 paid holidays per year. Medical, Dental and Vision benefits are offered to all associates and are effective on the 1st day of the following month after hire. Enrollment in 401k after 90 days. The Manufacturing Operator/Technician II is responsible for all functions relating to the processing of drug products; consistent with established Current Good Manufacturing Practices (cGMP), customer requirements and in conjunction with all Standard Operating Procedures (SOP). Responsible for the safe and efficient execution of their job duties, while ensuring product compliance to established standards. Major Areas of Responsibility  Execute Batch Record and logbook documentation with clear details and accuracy.  Execute the procedures used to clean pharmaceutical production equipment and facilities.  Operates pharmaceutical production machinery and executes procedures for manufacturing such as dispensing, mixing, coating, encapsulating, granulating, drying, milling, blending, compressing etc.,  Executes total changeovers and cleaning.  Identifies and assists in the corrective actions of processing related issues.  Maintains production reporting for assigned work unit operation.  Performs required in-process product quality checks and document accurately.  Execute procedures to complete tasks in a safe, compliant and efficient manner.  Works in collaboration with others as part of a team.  Assists with on the job training of other production trainees and operators.  May determine methods and procedures on new assignments and may provide assistance to other support personnel.  Effectively communicates issues to supervisor.  Adheres to all cGMPs, compliance/regulatory mandates and quality requirements.  Assists in the identification and implementation of continuous improvement opportunities.  Performs other related duties as assigned to meet departmental and Company objectives. Required Knowledge, Skills and Abilities  Knowledge of Metric and English weighing and measurements systems.  Basic understanding of mechanical machinery and the operating principles of control systems.  Demonstrated mathematical ability in addition, subtraction, multiplication, division, ratios and percentages.  Ability to use a calculator.  Ability to follow both verbal and written instructions including SOP’s and Batch Record documentation.  Accurate and precise in recording data and batch information.  Ability to work in both independent and team environments.  Proficient in reading and writing English to understand work instructions and document results.  Ability to operate pharmaceutical processing equipment.  Ability to meet required standards of cGMPs.  Demonstrated understanding of the unit operations and the ability to assist with on-the-job training of manufacturing trainees and operators. Education and Experience  High school diploma or general education diploma (GED).  Two years’ related experience or equivalent technical training/certification preferred; or a combination of related experience and technical training/certification. Physical Demands The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job:  Stand, walk, sit, climb, balance, stoop or crouch, kneel, reach, push, pull, grasp, feel, talk, and hear without any aids.  Capable of lifting or carrying and walk with a minimum of 30 kg alone without any support or aid and higher weights with support or aid as required.  Capable of moving the machines, filled containers, and other accessories alone or with support or aid as required.  Work different operational shifts from time to time as required.  Weekends / holidays and extended hours as required.  Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.  Operate trucks and other industrial vehicles to transfer the containers/production equipment.  Manufacturing operator/technician II are expected to operate any industrial machinery such as Forklifts, Hi-Lo, Reach Truck, Hand truck, Pallet Jack, Drum lifter etc. to lift, carry, push, pull or otherwise move objects. Work Environment The work environment characteristics described here are representative of those an individual encounter while performing the essential functions of this job:  Sufficient noise to occasionally cause the individual to shout in order to be heard above the ambient noise level.  Individual is in a proximity to moving mechanical parts, electrical current and exposure to chemicals.  Atmospheric conditions sometimes expose individual to dust, for which protective equipment is available.  Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face (Dust / Mist Respirator & Half-Face Air Purifying Respirator) and full-face negative pressure respirators  Individual may be required to wear hearing protection under certain conditions  Any employee required to use any type of Air Purifying Respirator must not have facial hair and must be cleanly shaven to assure a proper seal. Ingenus Pharmaceuticals LLC. is an Equal Employment Opportunity (EEO) employer and welcomes all qualified applicants. Applicants will receive fair and impartial consideration without regard to race, sex, color, religion, national origin, age, disability, veteran status, genetic data, or religion or other legally protected status. Company DescriptionIngenus Pharmaceuticals wants to hear from you. Ingenus Pharmaceuticals is at the forefront of the rapidly growing generic medication industry, delivering access to safe, quality medications to U.S. consumers all across the healthcare continuum. Our company is built around the principles of innovation and ingenuity, a world-class leadership team, and—most importantly—the best and brightest people in the pharmaceutical industry. Are you ready for a new challenge? Do you enjoy working with a diverse group of patients, suppliers and partners? Then come to Ingenus, where you can truly make a difference; where together, we change the world, one medication at a time. We set high standards and reward them with competitive benefits. If you consider yourself a standout in your profession, let’s talk to find out if we are the right fit for you.Ingenus Pharmaceuticals wants to hear from you. Ingenus Pharmaceuticals is at the forefront of the rapidly growing generic medication industry, delivering access to safe, quality medications to U.S. consumers all across the healthcare continuum. Our company is built around the principles of innovation and ingenuity, a world-class leadership team, and—most importantly—the best and brightest people in the pharmaceutical industry. Are you ready for a new challenge? Do you enjoy working with a diverse group of patients, suppliers and partners? Then come to Ingenus, where you can truly make a difference; where together, we change the world, one medication at a time. We set high standards and reward them with competitive benefits. If you consider yourself a standout in your profession, let’s talk to find out if we are the right fit for you.

Our pharmaceutical client is looking for a chemist to join their growing organization! If you are someone who wants to be a part of a highly technical team, this may be the role for you! The Chemist II/III will conduct release and stability testing for pharmaceutical products with specific focus on LC and GC chromatographic analyses as well as dissolution testing. This position involves conducting various analytical tests to ensure the quality and performance of solid dosage forms while maintaining a high level of laboratory safety and compliance. Key Responsibilities: • Prepare solid dosage samples for analysis by accurately weighing, blending, and homogenizing materials to ensure representative samples for testing., • Conduct dissolution testing of solid oral drug products using USP Apparatus I and Apparatus II., • Perform HPLC assays for the quantitative analysis of pharmaceutical components, including potency, purity, and samples from dissolution testing., • Ensure analytical instrumentation is properly maintained., • Ensure that all laboratory work complies with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP), following established Standard Operating Procedures (SOPs)., • Maintain accurate and detailed records of experiments, results, and procedures in laboratory notebooks and electronic systems, ensuring data integrity., • Adhere to safety protocols and participate in laboratory safety initiatives, ensuring a safe and compliant work environment. Minimum Qualifications: • Bachelor’s degree in chemistry with at least two (2) years of experience in the pharmaceutical industry., • Hands-on experience with HPLC, GC, Dissolution, and use of Empower software, • Strong analytical and problem-solving skills., • Excellent communication and teamwork skills., • Attention to detail and commitment to maintaining data integrity.

The Display and Exhibits Coordinator will coordinate the full logistics of all congresses and exhibits programs which include but not limited to, reviewing requests for accuracy, securing approvals, managing registration, executing customer-specific agreements, payment processing, marketing materials management, and program reconciliation. • Database management - manage promotional educational programs within the firm's proprietary events management platform, • Budget management - assisting customer representatives within their program planning budget to ensure they meet client business rules and guidelines, • Coordinate all life cycles of Congresses and Exhibits from start to finish, • Communicate daily with customer team and appropriate stakeholders, • Run daily metric reports to ensure all tasks within the C&E are executed within a timely fashion, • Coordinate with account stakeholders (via telephone and email) regarding their event status as well as required follow-ups for any missing information. Able to read, interpret, and execute legal contracts on behalf of stakeholders., • Ensure payments are processed in an efficient and timely manner, • Adhere to performance metrics, standard operation processes and procedures, as well as compliance guidelines for the related customer, • Maintain current knowledge of appropriate regulations, e.g., OIG, PhRMA Code, • Adherence to various policies (i.e., confidentiality, sensitive communication, intellectual property), • Effectively manage high volume of meetings while also responding to emails and phone calls Competency Requirements: • Strong interpersonal, verbal, and written skills both internally and externally with the ability to effectively engage with the customer, • Skilled in Customer Service, and the ability to solve problems while ensuring customer satisfaction is met, • Strong organizational skills with great attention to detail, • Familiar with health sciences and regulated environments, • Ability to work independently, with competent decision-making skills, and successfully manage multiple priorities in a fast-paced environment, • Strong working knowledge of Gmail and Microsoft Office Product Suite, and able to quickly learn to utilize similar tools and software as needed, • Positive attitude at all times and the ability to work with a team and maintain a “Whatever it Takes” attitude, • Ability to boost team morale, • Ability to take constructive feedback and adjust in order to progress forward, • Ability to take on additional ad hoc tasks as needed to support the team without complaint, • Ability to work flexible schedules and/or extended hours to meet clients’ business needs, • Ability to maintain productivity while performing repetitive planning tasks every day, • Basic Math and Spelling proficiency, • Ability to work and thrive in a team atmosphere Education/Skills Experience Desired: • A background in event planning is preferred, but not required, • B.S. or B.A. degree or equivalent experience, • 3+ years’ experience working at a pharmaceutical/biotech or third-party agency a plus, • Great for individuals with a Sales, Hospitality, or Customer Service background, • Must be a go getter and very personable at the same having patience with the process, • Possess strong analytical and problem-solving skills

Our pharmaceutical client is seeking a Junior Data Reviewer to support their expanding lab operations and play a role in bringing life-saving medicines to patients. This is a great opportunity for someone who is eager to gain industry experience. A strong scientific foundation and a willingness to learn with some familiarity with HPLC is a plus. If you’re willing to learn, detail-oriented, and excited about contributing to a growing company, we’d love for you to apply! Qualifications / Responsibilities: • Bachelor’s Degree in Life Sciences (Chemistry, Biology, or related field), • Review analytical data (e.g., HPLC, GC, dissolution, titrations) for accuracy, completeness, and compliance with cGMP and company SOPs, • Verify calculations, instrument outputs, and raw data entries against laboratory reports, • Maintain accurate, audit-ready records of data reviews in accordance with company procedures, • Develop working knowledge of regulatory requirements (FDA, EMA, ICH) and industry best practices for data integrity and review

QC Manager – Fairfield, NJ Summary: The QC Manager is primarily responsible for the daily operation of pharmaceutical Quality Control Laboratory. This position will manage the staff to schedule and perform all necessary testing to support manufacturing and release requirements. Responsible for training and personnel development. This is a hands- on position. In addition to managerial responsibilities, this position will be performing analytical testing including wet chemistry, GC, HPLC, etc. as needed Responsibilities: • Lead, coach and manage a team of analysts to ensure data integrity and performance to meet business objectives, • Train and develop analysts, • Formulate, document, and maintain quality control standards and on-going quality control objectives, • Schedule workload to meet release objectives and deadlines, • Review, interpret, analyze and report HPLC/GC/UV/FTIR data according to USP/NF/BP/EP/IP/JP/CEP/cGMP, and internal guidelines, • Author analytical methods and SOPs, • Clean, maintain, and troubleshoot HPLC/GC/UV/FTIR instruments, • Develop specifications and analytical methods as required, • Develop analytical methods to support product development projects, • Prepare analytical method validation protocols and reports, • Perform Laboratory Investigations, root cause analysis, CAPA, Change Controls, Validations, Stability Programs, APRs, statistical analysis, environmental monitoring of air, water, and surfaces, as needed., • Manage the outsourcing process of testing to contract laboratories, • Ensure lab safety and manage chemical inventory, • Improve the compliance of the laboratory operations as well improve the efficiency and reduce the cost of the operations, • Perform duties of QC Analyst as needed including HPLC sample preparation and testing and any other testing requirements, • Audit the work of QC Analysts, • Other duties assigned by Management Education: • Bachelor’s degree in a scientific discipline (Chemistry preferred) with a minimum of 5 years’ experience in laboratory management OR Master’s degree in a scientific discipline (Chemistry preferred) with a minimum of 3 years’ experience in laboratory management Experience Requirements: • Experience with Empower 3, • Experience working in an FDA regulated environment, • Experience with GC sample preparation and testing, • Knowledge of USP Monograph testing, analytical method development & validation, • Knowledge of CFR & ICH Regulatory Guidelines, • Knowledge of cGMP processes, lab safety and GDP. Computer Skills: • Proficiency in Microsoft Word, • Proficiency in Microsoft excel, • Proficiency in Empower 3 Other requirements: • Has significant technical knowledge of scientific principles, theories, and practices of analytical chemistry in an FDA inspected pharmaceutical quality control laboratory., • Able to perform complex mathematical problems, • In depth knowledge of all laboratory equipment, practices, and procedures, • Demonstrated managerial abilities, • Problem analysis, solving and resolution skills, • Has excellent oral and written skills, • Has excellent interpersonal skills, • Is self motivated, • Has a very high attention to detail, • Has a positive attitude, • Must speak, read, and write in English, • Able to lift 25 pounds, • Able to stand for extended periods Hours: • Standard: 8:30 AM to 5:00 PM, Monday through Friday, • Occasionally: Extended hours and/or Saturday and Sunday may be required as necessary to support manufacturing.

Job DescriptionJob Title: Pharmacist Pharmacy Name: Sinai Pharmacy Location: 121 W Broadway, Paterson, NJ - 07522 Position Type: Full-Time (Immediate Joining Preferred) Job Description:Sinai Pharmacy is seeking a dedicated and highly skilled Pharmacist to join our team. We are looking for a professional who can dispense medications accurately, provide excellent pharmaceutical care, and ensure compliance with all relevant laws and regulations. If you are motivated and committed to excellence in patient care, we encourage you to apply. Candidates available for immediate joining are preferred. Key Responsibilities:- Medication Dispensing: Accurately dispense prescription medications to patients.- Patient Counseling: Provide detailed counseling on medication usage, potential side effects, and interactions.- Regulatory Compliance: Ensure adherence to federal, state, and local pharmacy regulations.- Controlled Substances Management: Maintain accurate records and manage controlled substances responsibly.- Staff Training: Oversee and train pharmacy staff to ensure adherence to best practices.- Collaborative Care: Work with healthcare providers to manage and improve patient care.- Inventory Management: Maintain optimal inventory levels to prevent shortages and overstock.- Insurance Processing: Handle insurance claims processing and reimbursement efficiently.- Customer Service: Address and resolve patient inquiries and concerns professionally. Job Requirements:- Must Have: A valid state required pharmacist license- Must Have: Doctor of Pharmacy (Pharm.D.) degree from an accredited institution.- Preferred: Minimum of 3-5 years of experience in a pharmacy setting. Skills: - Strong knowledge of federal and state pharmacy laws and regulations. - Proficiency with pharmacy management software systems. - Excellent communication and interpersonal skills. - Ability to work efficiently in a fast-paced environment. - Strong attention to detail and organizational skills. - Commitment to providing exceptional patient care. Preferred Qualifications:- Certification in Medication Therapy Management (MTM).- Experience with inventory management and cost-saving measures.- Proven track record of effectively managing a pharmacy team. Benefits:- 401(k) matching- Performance-based bonus- Competitive salary- Paid time off- Training and development opportunities- Wellness resources We look forward to reviewing your application. Sinai Pharmacy is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Job DescriptionJob Title: Pharmacist In Charge PIC Pharmacy Name: Presidential Pharmacy Location: 121 W Broadway, Paterson, NJ - 07522 Position Type: Full-Time Immediate Start Preferred Company Overview: Presidential Pharmacy is looking for a dedicated and experienced Pharmacist to join our team. We are committed to delivering exceptional patient care and ensuring that our pharmacy operates in full compliance with all relevant laws and regulations. If you are passionate about pharmaceutical care and ready to make a difference, we invite you to apply. Candidates available for immediate start are preferred. Key Responsibilities: • Medication Dispensing: Accurately dispense prescription medications to patients., • Patient Counseling: Provide thorough guidance on medication usage, potential side effects, and interactions., • Regulatory Compliance: Ensure compliance with federal, state, and local pharmacy regulations., • Controlled Substances Management: Maintain precise records and responsibly manage controlled substances., • Staff Training: Train and mentor pharmacy staff to uphold best practices., • Collaborative Care: Collaborate with healthcare providers to enhance patient care., • Inventory Management: Monitor and manage inventory levels to avoid shortages or excess., • Insurance Processing: Efficiently handle insurance claims and reimbursements., • Customer Service: Professionally address and resolve patient inquiries and concerns.Job Requirements:, • Required: Valid pharmacist license as per state regulations., • Required: Doctor of Pharmacy (Pharm.D.) degree from an accredited institution., • Preferred: 3-5 years of experience in a pharmacy setting.Skills:, • In-depth knowledge of federal and state pharmacy laws and regulations., • Proficiency in pharmacy management software., • Excellent communication and interpersonal abilities., • Strong organizational skills with a keen attention to detail., • Ability to thrive in a fast-paced environment., • Dedication to providing outstanding patient care.Preferred Qualifications:, • Certification in Medication Therapy Management (MTM)., • Experience in inventory management and implementing cost-saving measures., • Proven success in managing a pharmacy team effectively.Benefits:, • 401(k) matching, • Performance-based bonuses, • Competitive salary, • Paid time off, • Opportunities for training and professional development, • Wellness resourcesPerks:, • Competitive Compensation: Attractive salary and benefits packages., • Supportive Environment: Work within a collaborative team that values your contributions., • Career Advancement: Opportunities for growth and development within the organization., • Work-Life Balance: Flexible schedules to support a healthy work-life balance.Why Join Us?, • Supportive Environment: Be part of a team that values your input and fosters your growth., • Growth Opportunities: Advance your career with ample professional development options., • Balanced Schedule: Enjoy a healthy work-life balance with our flexible schedules., • Competitive Packages: Benefit from attractive compensation and growth potential.We look forward to receiving your application! Presidential Pharmacy is an equal opportunity employer. We celebrate diversity and are committed to fostering an inclusive environment for all employees.

Job DescriptionJob Title: Full Time Pharmacist Position Type: Full-Time (Immediate Joining Preferred and Available to work weekends) Job Description: Icare Pharmacy Plus is seeking a dedicated and highly skilled Pharmacist to join our team. We are looking for a professional who can dispense medications accurately, provide excellent pharmaceutical care, and ensure compliance with all relevant laws and regulations. If you are motivated and committed to excellence in patient care, we encourage you to apply. Candidates available for immediate joining are preferred. Key Responsibilities:- Medication Dispensing: Accurately dispense prescription medications to patients.- Patient Counseling: Provide detailed counseling on medication usage, potential side effects, and interactions.- Regulatory Compliance: Ensure adherence to federal, state, and local pharmacy regulations.- Controlled Substances Management: Maintain accurate records and manage controlled substances responsibly.- Staff Training: Oversee and train pharmacy staff to ensure adherence to best practices.- Collaborative Care: Work with healthcare providers to manage and improve patient care.- Inventory Management: Maintain optimal inventory levels to prevent shortages and overstock.- Insurance Processing: Handle insurance claims processing and reimbursement efficiently.- Customer Service: Address and resolve patient inquiries and concerns professionally. Job Requirements:- Must Have: A valid state required pharmacist license- Must Have: Doctor of Pharmacy (Pharm.D.) degree from an accredited institution.- Preferred: Minimum of 3-5 years of experience in a pharmacy setting. Skills: - Strong knowledge of federal and state pharmacy laws and regulations. - Proficiency with pharmacy management software systems. - Excellent communication and interpersonal skills. - Ability to work efficiently in a fast-paced environment. - Strong attention to detail and organizational skills. - Commitment to providing exceptional patient care. Preferred Qualifications:- Certification in Medication Therapy Management (MTM).- Experience with inventory management and cost-saving measures.- Proven track record of effectively managing a pharmacy team. Benefits:- Performance-based bonus- Competitive salary- Paid time off- Training and development opportunities- Wellness resources Why Join Us:- Supportive Environment: Be part of a team that values and supports your contributions.- Growth Opportunities: Advance your career with opportunities for professional development.- Balanced Schedule: Maintain a healthy work-life balance with our balanced work schedules.- Competitive Packages: Benefit from competitive salary packages and growth opportunities. We look forward to reviewing your application. Icare Pharmacy Plus is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Job Description Clinical Trial Recruiter RCT 101/100 Job Type: Full Time and Part Time positions available Seeking individuals for Clinical Trials Recruiter position in our Fairfield, NJ facility. CPTC provides testing and consultation services to the pharmaceutical, cosmetic, personal care, medical device and household product industries. Job Type: Full Time/Part Time: Base Hours vary MINIMUM QUALIFICATION REQUIREMENTS To perform this job, an individual must be able to perform each essential duty satisfactorily, and meet the educational and experience requirements. ESSENTIAL DUTIES AND RESPONSIBILITIES • Review database for panelists with matching inclusion/exclusion criteria to upcoming clinical trial protocols., • Contact potential subjects and discuss clinical trial requirements and availability to participate, • Ensure compliance with protocols, and standard operating procedures, • Data entry of subject data into database · High School diploma / GED required · General Office Equipment Skills · 2 years clerical experience preferred COMMUNICATION SKILLS • Computer skills: MS Word and Excel required, • Organizational, analytic, and problem-solving skills, • Attention to detail; ability to maintain confidentiality PHYSICAL REQUIREMENTS On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch; talk, hear, and smell. Specific vision requirements including reading of written documents, visual inspection of documents and use of computer monitor screen frequently. This position entails repetitive motion with keyboard and mouse. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age or any other characteristic protected by law. Company DescriptionConsumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.Consumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.

Job Description We are looking for Onsite Licensed Pharmacist to join our New Jersey Team! Specialty Rx is a Long-Term Care pharmacy providing pharmaceutical services to long-term care facilities and assisted living communities. Specialty Rx takes pride in delivering personalized care and quality pharmacy services. Please apply here Licensed Pharmacists, please apply; we offer a competitive salary and benefits package. License Pharmacist Responsibilities: • Evaluate medication orders for appropriateness of drug, dosage, potential interactions, and proper administration., • Ensure that dispensed medicines are correctly supplied and labeled., • Communicate with facilities’ nursing staff, physicians, and other healthcare team members in regard to medication-related queries., • Supervise the preparation of any medicines License Pharmacist Requirements: • Active Pharmacist with NJ Board of Pharmacy a must, • Previous experience in Long Term Care preferred, • Strong analytical and critical thinking skills, • Strong attention to detail, • Ability to work independently, accurately, and efficiently, • Must be multi-tasking and reliable, • Computer literate, knowledge of Frameworks LTC system, PLUS Full Time-Hours: 4:00pm-Closing (Monday through Friday/rotating weekends) (2nd Shift Differential) EEO Statement, SpecialtyRx, Inc. is fully committed to employing a diverse workforce. We recruit and retain talented individuals without regard to gender, race, age, marital status, disability, veteran status, sexual orientation gender identity, or any other status protected by federal, state, or local law. EO/Minorities/Females/Disabled/Veterans Company DescriptionSpecialtyRx is focused on supporting the healthcare facility as a unit. As an administrator or nurse manager, you need reliable medication dispensing, fail-proof availability and delivery, expert compounding and interchange services, and more all while meeting industry standards and maintaining compliance with federal and state regulations. That's where a long-term partnership with SpecialtyRx transforms your care capacity. Through quality medication therapy, strong communication, and continued education, we effectively increase efficiency, reduce costs, and enable better care all around.SpecialtyRx is focused on supporting the healthcare facility as a unit. As an administrator or nurse manager, you need reliable medication dispensing, fail-proof availability and delivery, expert compounding and interchange services, and more all while meeting industry standards and maintaining compliance with federal and state regulations.\r\n\r\nThat's where a long-term partnership with SpecialtyRx transforms your care capacity. Through quality medication therapy, strong communication, and continued education, we effectively increase efficiency, reduce costs, and enable better care all around.

Inizio Engage has a long-standing partnership with worldwide leading pharmaceutical company to offer support for an expanding product portfolio in primary care. We are seeking a performance driven Pharmaceutical Field Sales Representative with strategic problem- solving skills, that can collaborate with multiple stakeholders. The Ideal candidate will demonstrate a track record of sales success or related experience, regardless of industry background. Pharmaceutical experience is not required. We are seeking individuals who can quickly make a meaningful impact, leveraging their proven ability to deliver results, build relationships and adapt in a dynamic environment. The Pharmaceutical Field Sales Representative will achieve sales and activity targets on assigned territories across primary care customers and meet all relevant standards as set by Inizio and Sales leadership. This is your opportunity to join Inizio Engage and represent a top pharmaceutical company! What’s in it for you? • Competitive compensation, • Excellent Benefits – accrued time off, medical, dental, vision, 401k, disability & life insurance, paid maternity and paternity leave benefits, employee discounts/promotions, • Employee discounts & exclusive promotions, • Recognition programs, contests, and company-wide awards, • Exceptional, collaborative culture, • Best Places to Work in BioPharma (2022, 2023, & 2024), • Certified Great Place to Work (2022, 2023, 2025) What will you be doing? • Driving demand through clinical selling and education to targeted Physicians, • Establish, maintain and develop strong relationships with HCPs (includes physicians, Nurses, NP, PA, MA, etc.), • Deliver sales messaging, patient and product information to targeted HCP offices, • Achieve or exceed activity targets as set by the company, • Complete administrative items daily, • Comply with all client and Inizio policies, including compliance and ethics requirements, and trainings, • Effective time management and coordination of:, • Routing plans, • Daily/weekly call activities, • Demonstrate persistence towards accomplishing defined sales objectives, • Must have a dependable automobile with insurance coverage in compliance with company guidelines., • Collaborate with geographic partners What do you need for this position? • Bachelor’s degree, • Business to Business sales experience preferred, • Comfort with Technology/Virtual Engagements, • Ability to travel up to 20% of time as required (some territories could be more than 20%), • Overnight Travel Required, • Valid driver’s license and clean driving record About Inizio Engage Inizio Engage is a strategic, commercial, and creative engagement partner that specializes in healthcare. Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people and providers to improve treatment outcomes. Our mission is to partner with our clients, improving lives by helping healthcare professionals and patients get the medicines, knowledge and support they need. We believe in our values: We empower everyone/We rise to the challenge/We work as one/We ask what if/We do the right thing, and we will ask you how your personal values align to them. To learn more about Inizio Engage, visit us at: ___ Inizio Engage is proud to be an equal opportunity employer. Individuals seeking employment at Inizio are considered without regards to age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition (including pregnancy, childbirth, or related medical conditions), mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. Further, pursuant to applicable local ordinances, Inizio will consider for employment qualified applicants with arrest and conviction records. Inizio Engage is an equal opportunity employer M/F/V/D. We appreciate your interest in our company, however, only qualified candidates will be considered.

Job DescriptionJob Title: QA InvestigatorJob Description We are seeking a dedicated QA Investigator to join our team. The role involves writing and completing investigations and deviations, ensuring compliance from both compliance and operations perspectives. The ideal candidate will conduct root cause analysis and manage the entire lifecycle of investigations independently, communicating effectively with vendors and manufacturing teams. Responsibilities • Determine the causes and preventative actions of Deviations, Non-Conformances, Out of Specification (OOS), Out of Trend (OOT), field complaints, and environmental excursion investigations., • Drive investigations to true root cause using appropriate investigation tools and benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track Corrective and Preventive Action (CAPA) plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Effectively utilize change management approaches., • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy, and deviation processes., • Champion CAPA plans and implementation., • Provide communication plans for ongoing deviations and CAPAs., • Create and communicate CAPA plans effectively to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • 2-3 years of experience writing and reviewing deviations and investigations., • Experience within a pharma company supporting manufacturing., • Previous experience within a quality assurance team., • Bachelors degree within a related scientific field., • Experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology, or Bio-Pharma., • Root cause analysis experience in pharmaceutical or FDA regulated operations., • Experience using e-Quality Management Systems., • Experience with CAPA and GMP., • Knowledge of biopharma/biotech and biologics., • Technical writing skills. The QA Investigator will work closely with quality assurance and a team of QA/QC professionals on a daily basis, collaborating cross-functionally with the manufacturing team. The role is based at two sites located a block apart, and the team currently includes five other investigators. The position operates on a first-shift schedule from Monday through Friday, with start times at either 8 am or 9 am. The company offers a supportive work culture with opportunities for growth and expansion, focused on saving patients' lives. Job Type & Location This is a Contract to Hire position based out of Allendale, New Jersey. Pay and Benefits The pay range for this position is $40.00 - $46.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Allendale,NJ. Application Deadline This position is anticipated to close on Sep 19, 2025. 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 due to a disability, please email for other accommodation options.

Job DescriptionCompliance Investigator, Clinical ManufacturingAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Compliance Investigator, Clinical Manufacturing leads life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventative actions to ensure compliance. • Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, field complaints and environmental excursion investigations., • Drive investigations to true root cause using appropriate investigation tools., • Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track CAPA plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Effectively utilize change management approach., • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process., • Champion CAPA plans and implementation., • Provide communication plan for on-going deviations & CAPA’s., • Effectively create and communicate CAPA plan to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • Ability to abide by quality standards.REQUIREMENTS, • BS degree in a Quality/ Process related field., • Experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology or Bio-Pharma., • Root cause analysis experience in pharmaceutical or FDA regulated operation preferred., • Experience using e-Quality Management Systems preferred., • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Flexible and able to adapt to company growth and evolving responsibilities, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • Ability to work effectively as a team and independently., • Quality Systems Training (Deviation/CAPA)Working Environment While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. Non-absorbent laboratory coats are required, as well as latex (or a non-latex substitute) gloves. When working with potentially hazardous materials that may spray, aerosol, or otherwise contact skin or mucous membranes, face shields or goggles must be worn. Heavy cryo-gloves must be used when working with liquid nitrogen. 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.

Job DescriptionQC Analytical Compliance Investigator Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. Our client is seeking a QC Analytical Compliance Investigator to lead life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventative actions to ensure compliance. • Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, field complaints and environmental excursion investigations., • Drive investigations to true root cause using appropriate investigation tools., • Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track CAPA plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Effectively utilize change management approach., • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process., • Champion CAPA plans and implementation., • Provide communication plan for on-going deviations & CAPA’s., • Effectively create and communicate CAPA plan to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • Ability to abide by quality standards.REQUIREMENTS, • BS in a Quality / Process related field., • Experience in GMP Operations and/or QA in Cell Therapies, Biotechnology or Bio-Pharma., • Root cause analysis experience in pharmaceutical or FDA regulated operation preferred., • Experience using e-Quality Management Systems preferred., • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Flexible and able to adapt to company growth and evolving responsibilities, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • Ability to work effectively as a team and independently., • GMP Trained, Quality Systems Trained (Deviation/CAPA)Working EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy. Physical RequirementsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Non-absorbent laboratory coats are required, as well as latex (or a non-latex substitute) gloves. When working with potentially hazardous materials that may spray, aerosol, or otherwise contact skin or mucous membranes, face shields or goggles must be worn. Heavy cryo-gloves must be used when working with liquid nitrogen. Other DutiesPlease 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.

Job DescriptionQuality Assurance Compliance SpecialistAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the Associate Manager of Quality Compliance. Responsible to perform Quality Assurance Compliance activities in support of Quality Systems and/or client procedures, including but not limited to, document. management: investigations, CAPA, SOPs, qualification and validation reports, QC data. Supports Quality management with various department, organizational and operational excellence initiatives. Generally, exercises independent judgment, within generally defined practices and policies, when selecting methods and techniques for obtaining solutions. This role supports internal and external audits which may include interaction with Health Authorities and clients. • Liaises with relevant functional groups (Operations, Facilitates, QC, EH&S) to provide guidance through all stages of the investigation / CAPA processes., • Develops and communicates investigation strategy to key stakeholders., • In order to close investigation and CAPA, collect necessary information from appropriate department to close in quality system and maintain investigation and CAPA log, • Reviews and approves investigations and CAPAs;, • Conducts weekly status update meetings with cross functional departments and other stakeholders., • Monitors DR/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review to management on periodic basis., • Prepares and issues change control as necessary., • Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company’s processes and procedures., • Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations., • Conducts trend analysis of compliance related metrics such as deviations and CAPAs., • Performs supplemental investigations and/or participates in project teams or assignment as necessary., • Support in agency, internal and/or client audits., • Functional/Technical Skills: has the functional and technical knowledge and skills to do the job at a high level of accomplishment., • Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions., • Drive for Results: Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results., • Written Communication: Able to write clearly and succinctly in a variety of communication settings and styles., • Peer Relationships: Quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.REQUIREMENTS, • BS biological sciences or other relevant field of study., • 5 years’ + experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Familiar with FDA, ISO, and other regulatory agency guidelines., • Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required., • Working knowledge and technical understanding of aseptic manufacture of biologics preferred., • Experience in both clinical and commercial manufacturing is preferred., • Experience in supporting health authority inspections and/or client audits preferred., • Minimum Required Training (optional); GXP training, SOP & WI training, Safety Training, • Understanding and comprehension of quality system applications.Working Environment Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit.Must be able to work in a team-oriented environment.Must be able to work occasional weekends, nights, and/or holidays as required/necessary.May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids.Must be able to handle the standard moderate noise of the manufacturing facility.Must be able to work in open floor plan environment and may work in close proximity to others.Wheel-o-Vator available for use.Small breakroom available. No on-site cafeteria available.Able to utilize equipment in manufacturing are as well QC laboratories.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.

Job Description Summary The Quality Validation Specialist will be responsible for ensuring that finished products meet company standards through inspecting, assessing, and testing of products, integrations, and implementations of new equipment and processes. The candidate will support the day-to-day activities pertaining to the lab, customer complaints, environmental monitoring, and validations (equipment, cleaning, process and products). The ideal candidate must understand lab procedures and process validation strategies. The position will report directly to the Lab Supersivor with oversight by the QA Manager. This role offers responsibility, variety and the satisfaction that your role makes a real impact on our success Responsibilities • Assist QA management with implementing various quality systems (SQF, Organic, Kosher, RSPO, UTZ, etc.), • Assist with lab testing, sample collection, sensory evaluation, shelf-life retention monitoring, • Communicate corrective actions to suppliers/vendors., • Assist in implementation of corrective actions required as a result of an audit or internal finding, • Communicate nonconforming products to appropriate personnel., • Write technical reports and supporting documentation such as deviation, CAPAs, reports, testing protocols, and trend analyses preventative/corrective actions. Ensure timely closure of investigations., • Participate in internal audits for compliance with SOPs, GMPs, and regulations., • Participates actively in technology transfer, method qualification and validation., • Experienced with GFSI and HACCP Scheme (SQF, BRC), • HACCP and PCQI Certified is not required but a plus, • 1-2 years of relevant work experience in a medical device, pharmaceutical, or food processing industry field., • Knowledge of Regulations and Standards: Familiarity with relevant regulations and standards, such as cGMP (Current Good Manufacturing Practices) GMP experience in manufacturing environment., • Working knowledge of safety rules, regulations and training., • Bilingual (Spanish/English), • Good Communication skills: Ability to communicate effectively with technical and non-technical personnel., • Technical Writing: Intermediate to advance, • Problem-Solving Skills: Ability to identify and resolve issues related to validation activities., • Strong working knowledge of Microsoft Excel, Microsoft Word, Microsoft PowerPoint and Microsoft Outlook, • The ability to solve practical problems or issues and report in a high level, • Ability to work in a team environment, • Scientific Background: Typically requires a bachelor's degree in a scientific field, such as biology, chemistry, or engineering., • Technical Proficiency: Familiarity with laboratory equipment and validation techniques, methodologies., • Analytical Skills: Strong analytical skills to evaluate data and identify trends.

Job DescriptionQuality Assurance Manager The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily tasks in support of corporate Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases as well as assists Quality management with department needs.The ideal candidate in this role, the Manager, Quality Assurance exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements ongoing quality improvement processes working with interdepartmental teams. Develop and manage quality assurance metrics for performance improvement of all teams. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments. Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation. • The QA Manager will delegate responsibilities to direct reports (QA Associate I, II, and III) to achieve the requisite business needs, while providing ongoing support to Manufacturing processes., • Ensure the safe release of cellular products in accordance with HCATs and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Establish and maintain policy for documentation of all products and perform internal documentation audits., • Author and review relevant SOPs, validation and other documents., • Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review., • Control Master Batch Records, distribution and label verification., • Perform line clearance activities as required., • Assign and maintain product lot numbers as applicable., • Ensure materials management nonconformance disposition and release activity as applicable., • Ensure accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks., • Provide support to manufacturing for investigations of deviations, validations, and development of specifications, • Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements., • Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted., • Perform employee training on QSR and ISO requirements and company quality systems, • Perform document control activities as assigned., • Mentor/train/develop and manage Quality Assurance team., • Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality AgreementsREQUIREMENTS, • BS Degree in biological sciences or equivalent., • Minimum 5-10 years related experience in the pharmaceutical or biologics industry., • Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)., • Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc., • Sound knowledge of aseptic processing and supporting technologies., • Analytical and technical troubleshooting skills are a plus., • Proficient with Microsoft Office Suite., • Excellent organizational skills and attention to detail., • Good verbal and written communication skills., • Strong team-oriented interpersonal skills are essential., • Travel may be required, • Strong business acumen, • Experience with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task is essential, • Flexible and able to adapt to company growth and evolving responsibilitiesPlease 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.

Job Description NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. We're exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. In Japan. Job Summary: Manage the execution of assigned global clinical studies with adherence to all relevant regulations including FDA, ICH, and Regulatory requirements. This is a hybrid position that requires two days in the Paramus, NJ office. Essential Duties/Responsibilities: • Assist in planning, implementing, manage and reporting for regional or global clinical studies., • Manage selection process of CROs for regional or global clinical studies., • Manage the performance of study vendors (e.g., CROs and central labs), • Manage activities for clinical site selection, investigator meetings and study initiation., • Oversight of patient recruitment and development of recruitment strategies and plans, • Support for the creation of study related documentation (protocol, ICF, CRF, operations manuals, etc.), • Tracking clinical data, regulatory documents, and patient enrollment information and data resolutions to ensure the timely completion of clinical studies in line with approved clinical development plans., • Assure compliance of investigational sites with SOPs, FDA regulations and ICH guidelines to ensure that the studies are conducted fulfilling the requirements of the study protocols., • Coordinate negotiation of clinical trial contracts between investigational sites and CROs., • Manage data management vendors and statistical analysis vendors to ensure timely analysis output delivery in accordance with Statistical Analysis Plan., • Support for coordination with clinical suppliers to ensure appropriate and timely delivery of clinical trial supplies to clinical sites., • Implement project specific training program and training materials., • Support Creating and maintaining clinical SOPs and inspection-ready TMF as part of global QMS and TMF processes., • Perform administrative tasks (e.g., coordination, schedules, submission, filing, etc.)., • Must be able to manage and coordinate with the Clinical Lead to achieve project objectives and able to manage/solve project management performance issues if they arise., • Demonstrated ability to support the development and management of various aspects of the end-to-end study operational plan., • Must be able to work effectively in a multi-cultural, global team environment as responsibilities include intensive drug development collaboration with global project teams, Head Office in Japan, external partners, and vendors., • Thorough understanding of clinical operations involved as related to the planning, launching, and closing clinical studies., • Ability to manage multiple tasks and prioritize., • Strong organizational, communication and presentation skills., • Team player, flexible, ability to adapt to change., • Bachelor’s degree in sciences or related field with a minimum of 5 years of pharmaceuticals/biotech experience in a matrix environment, • Minimum of 5 years of drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials. NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job. The annualized target salary range for this role is $150,000 to $175,000; actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit. Other benefits include: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Account, Health Savings Account, and Employee Assistance Programs, • Discretionary Bonus Programs and Long-term Incentive Plan, • Retirement Savings 401k with company match, • Generous Paid Time Off, Sick Time & Paid Holidays including a paid Year-End Shutdown., • Career Development, Progression and Training NS Pharma is an EEO employer.

Job Description Job Title: Production Support Engineer II Department/Division: Engineering Reports to: Manager- Mechanical Engineering About LTS: LTS Lohmann Therapy Systems is a premier, global Contract Development and Manufacturing Organization (CDMO) and partner the pharma industry trusts most to deliver innovative oral, transdermal, and intradermal drug delivery systems. From concept to market, launch to lifecycle management, we deliver single source oral and transdermal drug delivery solutions that power partners’ market advantage. Every one of our 1,000 plus members of the LTS family, across three continents, is focused on utilizing our collective strength and innovation to explore new therapeutic opportunities, maximize partner value and improve patient outcomes. We Care. We Create. We Deliver. Job Summary: As a Production Support Engineer, you’ll provide mechanical engineering services in a pharmaceutical manufacturing environment. You’ll support plant maintenance teams and ensure the efficient service of production machinery, equipment, utilities, and facilities—all while focusing on production uptime and metric improvements. This is a full-time onsite position located in West Caldwell, NJ • This role supports our 1st shift starting between 7:00am to 9:00am for 8 working hours Monday through Friday, • Some on-call required What You Will Do: • Spend days "on the floor" troubleshooting and resolving production issues to manufacturing maintain continuity., • Support spare parts management, procurement, and inventory., • Lead small equipment improvement projects and vendor evaluations., • Write and execute GMP documentation including SOPs, CAPAs, and Change Controls., • Support maintenance planning and preventive calibration., • Maintain engineering documentation and technical libraries., • Serve as a subject matter expert across various manufacturing systems., • Bachelor’s degree in Mechanical Engineering or related field., • 2-3 years of experience in pharmaceutical, manufacturing, or packaging preferred, • Strong customer service orientation, • Strong mechanical and mathematical skills., • Basic computer and communication skills., • Ability to wear required PPE and lift up to 24 lbs., • Experience with Minitab/AutoCAD helpful., • Ability to visualize and troubleshoot equipment issues., • Experience integrating new innovations into existing methods., • Knowledge of GMP protocols and regulatory compliance., • Strong documentation and organizational abilities., • Leadership and collaboration across global teams. If this sounds like you, we want to hear from you! LTS is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Job DescriptionQuality Control Manager, Training & ComplianceAllendale, NJ The Quality Control (QC) Manager, Training and Compliance will manage the training and compliance programs across the analytical and microbiological laboratories. This role will ensure that there is a robust training program for the analytical and microbiological laboratories. In addition, this role will manage compliance activities within the laboratory such as deviations, CAPAs, document review, etc. The QC Manager will also be responsible for the management of external laboratories to include development of Quality Agreements, review of test results and resolution of any issues. • Develop and maintain training program within Quality Control which includes, onboarding and continuous training, • Manage deviations, CAPAs, change controls and document review to ensure compliance, • Ensure OOS investigations are completed adequately., • Manage external laboratories to include development of Quality Agreements, monitoring of samples and test results, reviewing deviations/OOS investigations, resolving issues and developing a scorecard to monitor the quality performance of the external laboratories, • Identify resources needed for training and compliance and build team accordingly, • Ensure compliance with applicable cGMP regulations while ensuring compliance with company and client requirements., • Monitor effectiveness of CAPAs, change control activities, and audit observation closure., • Directly supervises 1-4 employees within the Quality Control department(s).Directly supervised the following roles - Technical Trainers, Compliance Investigators, • Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions. REQUIREMENTS, • BA/BS/MS in a science or relevant field required, • Prior cGMP experience required, • Prior QC laboratory experience in a cGMP environment a must, • 3-5 years’ experience in the pharmaceutical, biologics ore related industry, • Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff with a minimum of five (5) years in a management position, • Sound understanding of cGMPs, • Experience in laboratory training and compliance, • External laboratory management experience, • Strong knowledge of testing methodologies, philosophies, method validation and method transfers., • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review, • Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner, • Experience with laboratory training programs, • Knowledge of GMP requirements, • Excellent organizational and leadership skills, • Outstanding analytical problem-solving abilitiesWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. 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.

Job DescriptionJob Title: Compliance Investigator Job Description We are seeking a dedicated Investigator responsible for writing and completing investigations and deviations from both a compliance and operations perspective. This role involves conducting root cause analysis, overseeing the full lifecycle of investigations, and ensuring adherence to GMP standards. Responsibilities • Write and complete investigations and deviations to ensure compliance with manufacturing and GMP standards., • Conduct root cause analysis and manage the full lifecycle of investigations independently., • Interview manufacturing personnel and communicate effectively with vendors regarding investigations., • Own and author deviations, determining causes and preventative actions for deviations, non-conformances, OOS, OOT, field complaints, and environmental excursion investigations., • Drive investigations to true root cause using appropriate tools and benchmark industry standards., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations at different stages to meet compliance deadlines and product release dates efficiently., • Collaborate with cross-functional teams to develop and track CAPA plans., • Identify and create trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify improvement opportunities., • Develop training materials and educate personnel on writing problem statements and using root cause analysis tools., • Champion CAPA plans and their implementation., • Provide communication plans for ongoing deviations and CAPA's., • 2-3 years of experience writing and reviewing deviations and investigations., • Experience working within a pharmaceutical company supporting manufacturing., • Experience within a quality assurance team., • Strong skills in root cause analysis and CAPA., • Bachelor's degree in a related scientific field., • Experience with biologics, aseptic techniques, and manufacturing environments., • Technical writing proficiency., • Experience using e-Quality Management Systems. You will work closely with a team of QA/QC professionals and cross-functionally with the manufacturing team. The team currently consists of 2-3 other investigators. You will work on the first shift, Monday through Friday, with an 8am or 9am start time, across two sites located a block away from each other. The role offers opportunities for growth, a positive work culture, and the satisfaction of contributing to saving patients' lives. Job Type & Location This is a Contract to Hire position based out of Allendale, New Jersey. Pay and Benefits The pay range for this position is $45.00 - $45.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Allendale,NJ. Application Deadline This position is anticipated to close on Sep 17, 2025. 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 due to a disability, please email for other accommodation options.

Job DescriptionQC Microbiology Compliance InvestigatorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. Leads life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventative actions to ensure compliance. • Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, environmental excursion investigations., • Drive investigations to true root cause using appropriate investigation tools., • Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track CAPA plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Effectively utilize change management approach., • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process., • Manage CAPA plans and implementation., • Provide communication plan for on-going deviations & CAPA’s., • Effectively create and communicate CAPA plan to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • Ability to abide by quality standards.REQUIREMENTS, • BS in a Quality / Process related field or equivalent experience., • 3-5 years of experience in quality control or quality assurance within the bio-pharma, biologics, or pharmaceutical industry or equivalent experience., • Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA, • Must have technical experience writing and assessing deviations, investigations, and Out of Specifications, • Must be able to analyze data/information and to assess and resolve complex problems, • Strong knowledge and understanding of U.S. and international cGMPs, ICH, and other regulations applicable to clinical and commercial manufacturing, • Knowledge of operational processes and controls in non-sterile and sterile operations, • Experience using e-Quality Management Systems preferred., • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Flexible and able to adapt to company growth and evolving responsibilities, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • Ability to work effectively as a team and independently., • Training; GMP Training, Quality Systems Training (Deviation/CAPA), Safety Training, Working EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. 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.

Job DescriptionOur Biotechnology client located in Allendale, NJ is seeking a Human Resources Business Partner who will provide human resources consultation and support to the Quality Department. This position is both operational and strategic in nature and provides HR expertise in the areas of talent management, organization design and effectiveness, performance management, employee relations, employee engagement, compensation, retention and process improvement initiatives. This role reports to the Sr. Director, Human Resources and will serve as a business partner to the Quality Leadership team and function. In addition, this role supports, implements, and executes all tactical aspects of the HR function. • Understand business needs in order to assess the HR implications of various business strategies., • Acts as liaison to other functions to ensure achievement of business objectives., • -Provide staffing and placement support to departments and divisions., • Facilitates the recruitment and on-boarding process for all new hires. HR Leadership: Coaching, developing and providing guidance to HR team members within assigned groups.Business Partner: Serving as a true business partner and advisor, gaining the trust of the organization in order to influence and provide effective HR processes, advice and support.Talent Acquisition: designing and executing workforce planning and recruitment strategies that attract and retain the best talent in the industry.Organization Effectiveness: Serves as a change agent in the organization, sponsoring change initiatives in support of organizational evolution.Employee Relations: Promoting a philosophy of employee relations throughout the company which emphasizes open communications, equal opportunities and treatment, continuous learning and reflects our core values.HR SME: Acting as a subject matter expert within the organization and providing interpretation, recommended best practices and ensures compliance with key legal requirements and adherence to company policies and procedures.Compensation: Ensures our compensation practices continue to attract and reward top talent. Oversee the salary administration to include annual performance management and compensation processes.Continuous Improvement: Analyzing trends and metrics in partnership with the HR team to draw insights, develop solutions, programs and policies. REQUIREMENTS, • -Bachelor’s degree in business, Human Resources or related field., • Minimum of ten years progressive HR/business leadership experience is required., • Demonstrated ability to build credibility and confidence with a wide variety of employees and leaders as a trusted advisor and confidant., • Ability to influence individuals at all levels of the organization., • Strong problem solving and conflict resolution skills., • HR Certification (PHR, SHRM-CP) or ability to obtain certification within one year of employment., • Prior experience in working in a matrix and complex operating environment preferred. Fast paced, challenging industry, • Build strong relationships with peers and cross functionally with partners outside of team to enable higher performance., • Highly ethical, authentic and committed to high integrity., • Learns fast, while being adaptable to the changing environment., • Look to raise the bar of service delivery and always seeks ways to address the status quo looking for ways to improve., • Communication proficiency: for both written and verbal communication, • Work collaboratively with all levels of employees., • Flexibility and adaptable in a high pressured, clinical and/or pharmaceutical environment., • Work with a composed attitude and behaves accordingly., • Action oriented with results, executes on all assigned goals and objectives, • Must have high level of interpersonal skills to ensure accurate flow of all information.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.

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.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.

Job DescriptionQuality Assurance Associate IIIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, SOPs, Qualification and Validation Reports; review of QC data; perform material releases and final product releases; review of Deviations as well as assists Quality management with department needs. He/she exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. This role manages internal and external audits which may include interaction with Health Authorities and clients • Interfaces directly with client and cross functional teams, • Provides resolutions pertaining to quality for project related issues, • Independently prioritize, schedule, and manage multiple projects and resources (team), • Ensures the safe release of cellular products in accordance with company and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Able to provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Author and review relevant SOPs, validation and other documents., • Responsible for the timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Responsible for the completion of all client requirements related to cellular product and/or material releases., • Master Batch Record Control, distribution and label verification, • Perform line clearance activities as required., • Assignment and maintenance of product Lot numbers as applicable., • Perform internal documentation audits as assigned., • Materials management nonconformance disposition and release activity as applicable., • Responsible for accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Track and trend relevant quality metrics including environmental monitoring data., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Electronic Document Control activities as assigned., • Provide training to personnel as assigned by supervisor., • Travel may be required.REQUIREMENTS, • BS in biological sciences or other relevant field of study, • 5 years + experience in QA in a life sciences company company with a strong focus in the manufacturing and/or testing of biologics., • Working knowledge and technical understanding of aseptic manufacture of biologics, • Understanding of quality system applications, • Experience in both clinical and commercial manufacturing is preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (validation/qualification reports, SOPS. Etc., • Experience in organizing teams for effective and timely completion of projects., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Experience participating in or hosting health authority inspections and/or client audits., • Computer skills (Microsoft Office, Outlook), • Detail-oriented and organized, • Analytical and problem-solving skills, • Good written and oral communication skills, • Ability to multi-task and be adaptable, • Flexible and able to adapt to company growth and evolving responsibilities, • Ability to work independently and with a team, • Strong Project Management and organization skills, • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the companyMay be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, etc. 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.

Job Description SUMMARY: • Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions., • Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions, • Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions, • Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines., • Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions., • Assess and communicate potential regulatory risks and propose mitigation strategies, • Understands, interprets and advises teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, and review and approval of applications., • Identify, communicate and escalate potential CMC regulatory issues, as needed, • Help establish regulatory CMC submission processes and procedures., • Familiar with eCTD format submission files, • Regulatory Documentation: Author and review CMC sections of regulatory submissions, including IND, NDA, and MAA applications., • Compliance & Guidelines: Ensure documents align with FDA, EMA, and ICH regulatory requirements., • Collaboration: Work closely with scientists, regulatory affairs teams, and manufacturing experts to gather accurate data., • Quality Assurance: Maintain consistency, clarity, and accuracy in technical writing. Education: Bachelor's or advanced degree in chemistry, pharmaceutical sciences, or a related field. Experience: • Prior experience in pharmaceutical or regulatory writing., • CMC (Chemistry, Manufacturing, and Controls) Writer experience.

Job DescriptionManager Manufacturing OperationsAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Primary Processing Unit (PPU), Manager, Manufacturing Operations is responsible for efficient capacity utilization of site resources to meet customer demand. They will partner with support functions to deliver on customer demands. This leader is accountable for the management of client projects at the site and for delivery of results within project scope, agreed timelines, contract requirements, revenue targets, as well as compliance and regulatory requirements. The Manager, Manufacturing Operations is responsible for profit and loss within their PPU and will deliver on revenue. This role will also drive individual and team development to ensure a prepared and empowered workforce to become the provider of choice for the industry. • Meet client process demands through planning, scheduling, manufacture and delivery., • of clinical cell therapy products according to established procedures, regulations and contract., • Ensures manufacturing documentation is closed out in a timely manner in accordance with applicable regulations and per contract., • Ensures capacity availability of resources (room/equipment/staff) to perform clinical manufacture for clients per contract., • Ensures process hours are charged - tracked to meet contract and revenue targets., • Accountable for maintaining a mechanism to work with clients to troubleshoot problems, suggests improvements and determines & advocates for value-add projects., • Assures manufacturing space is kept in a clean, validated state in compliance with company procedures, GMP and applicable regulations, • Ensures on the job training program and resources for new associate (proficiency) training and cross training of existing staff., • Ensures a safe work environment for employees., • Ensures department staff compliance with corporate and site-specific HR policies, safety and business policies and practice., • Approves job specific curriculum for the training and professional development of department staff., • Holds regular staff and 1:1 meetings to emphasize corporate culture, maintain morale, and provides a forum for staff development and discussion., • Responsible for the profit and loss for the PPU, • Deliver on revenue, • Assures compliance with budget, • Liaison with support groups – supply chain, training, quality systems, and business development, • Partners with clients along with Project Management and team leadership; drives the account management and liaison with the clients, • Sets team expectations and goals and delivers the business direction for the PPU, • Sets KPIs & ROIs targets and assures PPU metrics are maintained and tracked monthly., • Coordinates with PPU leadership and team meetings and determines PPU strategy development, • Accountable for driving the spirit of continuous improvement, • Collaborates with Business Development to ensure compliance and contract requirements, • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Directly supervises the following roles: Associate Manager, Manufacturing, Manufacturing Associates, Lead Manufacturing Associates, Production Support Associates, Technical Trainers, Compliance InvestigatorsREQUIREMENTS, • Bachelor's degree (ie Biology, Biotechnology, Bioengineering, Chemical Engineering)., • 5-7 years of cGMP environment, aseptic processing, mammalian cell culture, cell processing, cryopreservation experience., • 5-7 years of leadership experience or equivalent combination of experience., • Strong business acumen, • Deep understanding of cGMP and cGLP, • Working knowledge of financial operations and budget development, • Relevant IT skills (Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task team is essential, • Flexible and able to adapt to company growth and evolving responsibilities, • Drive to create and maintain order in a fluid technically complex environment, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • List required training that must be completed by incumbent in order to fulfill the responsibilities for this role. Examples can include aseptic techniques, gowning qualifications, manager training, GMP, etc., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the company, • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen, • Must have the ability to work in the cleanroom environment for extended period of time, • Must have the ability to work with specialized equipment, • May work with hazardous materials and chemicals, • Environment requires gowning, hair net, safety glasses, gloves, and foot coverings.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.

Job DescriptionHuman Resources ManagerAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Human Resources Business Partner will provide human resources consultation and support to assigned divisions. Understand business needs in order to assess the human resources implications of various business strategies. Acts as liaison to other functions to ensure achievement of business objectives. Provides staffing and placement support to departments and divisions. Facilitates the recruitment and on-boarding process for all new hires. This position is both operational and strategic in nature and provides HR expertise in the areas of talent management, organization design and effectiveness, performance management, employee relations, employee engagement, compensation, retention and process improvement initiatives. This role will report to the Sr. Director, Human Resources and will serve as a business partner to the Quality Leadership team and function. In addition, this role supports, implements, and executes all tactical aspects of the HR function. • HR Leadership: Coaching, developing and providing guidance to HR team members within assigned groups., • Business Partner: Serving as a true business partner and advisor, gaining the trust of the organization in order to influence and provide effective HR processes, advice and support., • Talent Acquisition: Designing and executing workforce planning and recruitment strategies that attract and retain the best talent in the industry., • Organization Effectiveness: Serves as a change agent in the organization, sponsoring change initiatives in support of organizational evolution., • Employee Relations: Promoting a philosophy of employee relations throughout the company which emphasizes open communications, equal opportunities and treatment, continuous learning and reflects our core values., • HR Expert: Acting as a subject matter expert within the organization and providing interpretation, recommended best practices and ensures compliance with key legal requirements and adherence to company policies and procedures., • Compensation: Ensures our compensation practices continue to attract and reward top talent. Overseeing salary administration to include annual performance management and compensation processes., • Continuous Improvement: Analyzing trends and metrics in partnership with the HR team to draw insights, develop solutions, programs and policies.REQUIREMENTS, • Bachelor’s degree in business, Human Resources or related field., • HR Certification (PHR, SHRM-CP) or ability to obtain certification within one year of employment., • 10 + years progressive HR/business leadership experience is required., • 5+ years in clinical and/or pharmaceutical industry., • Demonstrated ability to build credibility and confidence with a wide variety of employees and leaders as a trusted advisor and confidant., • Ability to influence individuals at all levels of the organization., • Strong problem solving and conflict resolution skills., • Prior experience in working in a matrix and complex operating environment preferred. fast paced, challenging industry., • Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance., • Highly ethical, authentic and committed to high integrity., • Learns, fast, while being adaptable to the changing environment., • Looks to raise the bar of service delivery and always seeks ways to address the status quo looking for ways to improve., • Communications proficiency: for both written and verbal communication., • Works collaboratively with all levels of employees., • Works with a composed attitude and behaves accordingly., • Action oriented with results, executes on all assigned goals and objectives.

Job Description The Opportunity: A highly ranked and leading global pharmaceutical company located in New Jersey seeks an Associate Senior Counsel - Market Access to join their legal team. This position is hybrid in Essex County with a compensation package between $236K - $248K, plus bonus, LTI and a competitive benefits package. Primary Duties: The Associate Senior Counsel - Market Access will report to an Associate General Counsel and will serve as a strategic legal advisor to the company's commercial teams, with a focus on market access, customer contracting, trade relations, government price reporting, patient support programs, and broader pharmaceutical regulatory matters.. Additional responsibilities are as follows: • Provide proactive legal counsel and day-to-day support on a broad range of market access and commercial matters., • Draft and negotiate complex agreements with key stakeholders across the healthcare supply chain, including payors, PBMs, wholesalers, GPOs, distributors, and pharmacies., • Advise on manufacturer-sponsored patient support programs, including co-pay assistance, coupons, reimbursement support, patient assistance programs, and adherence initiatives., • Ensure compliance with all applicable pharmaceutical laws and regulations, including the Anti-Kickback Statute, False Claims Act, federal and state pricing laws, PhRMA Code, and FDA guidelines., • Serve as legal representative on promotional review committees for market access materials., • Monitor and communicate relevant legal and enforcement developments, such as DOJ and OIG guidance and industry trends, to internal stakeholders., • Mitigate legal and reputational risks for assigned business clients by implementing sound legal strategies and policies., • Juris Doctor (JD) from an accredited law school., • Active member in good standing of a U.S. state bar., • Minimum seven years of legal experience, including at least four years advising the pharmaceutical or life sciences industry., • Deep understanding of FDA regulations, fraud and abuse laws, and/or government price reporting requirements., • Demonstrated ability to work in a fast-paced, cross-functional, and matrixed business environment.

Job DescriptionQuality Assurance Manager (Compliance)Allendale, NJ The Manager, Quality Assurance manages the PPU support unit services of the QA Department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily tasks in support of corporate Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases as well as assists Quality management with department needs. The ideal candidate in this role, the Manager, Quality Assurance exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements ongoing quality improvement processes working with interdepartmental teams. Develop and manage quality assurance metrics for performance improvement of all teams. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments. Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation. • The QA Manager will delegate responsibilities to direct reports (QA Associate I, II, and III) to achieve the requisite business needs, while providing ongoing support to Manufacturing processes., • Start-up Compliance arm of the Quality Assurance Department., • Ensure the safe release of cellular products in accordance with HCATs and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Establish and maintain policy for documentation of all products and perform internal documentation audits., • Author and review relevant SOPs, validation and other documents., • Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review., • Control Master Batch Records, distribution and label verification., • Perform line clearance activities as required., • Assign and maintain product lot numbers as applicable., • Ensure materials management nonconformance disposition and release activity as applicable., • Ensure accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks., • Provide support to manufacturing for investigations of deviations, validations, and development of specifications, • Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements., • Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted., • Perform employee training on QSR and ISO requirements and company quality systems, • Perform document control activities as assigned., • Mentor/train/develop and manage Quality Assurance team., • Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality AgreementsREQUIREMENTS, • BS Degree in biological sciences or equivalent., • Minimum 5-10 years related experience in the pharmaceutical or biologics industry., • Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)., • Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc., • Sound knowledge of aseptic processing and supporting technologies., • Analytical and technical troubleshooting skills are a plus., • Proficient with Microsoft Office Suite., • Excellent organizational skills and attention to detail., • Good verbal and written communication skills., • Strong team-oriented interpersonal skills are essential., • Travel may be required, • Strong business acumen, • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task is essential

Job DescriptionQuality Assurance ManagerAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily tasks in support of corporate Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases as well as assists Quality management with department needs. The ideal candidate in this role, the Manager, Quality Assurance exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements ongoing quality improvement processes working with interdepartmental teams. Develop and manage quality assurance metrics for performance improvement of all teams. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments. Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation. The QA Manager will delegate responsibilities to direct reports (QA Associate I, II, and III) to achieve the requisite business needs, while providing ongoing support to Manufacturing processes. • Ensure the safe release of cellular products in accordance with HCATs and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Establish and maintain policy for documentation of all products and perform internal documentation audits., • Author and review relevant SOPs, validation and other documents., • Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review., • Control Master Batch Records, distribution and label verification., • Perform line clearance activities as required., • Assign and maintain product lot numbers as applicable., • Ensure materials management nonconformance disposition and release activity as applicable., • Ensure accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks., • Provide support to manufacturing for investigations of deviations, validations, and development of specifications, • Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements., • Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted., • Perform employee training on QSR and ISO requirements and company quality systems, • Perform document control activities as assigned., • Mentor/train/develop and manage Quality Assurance team., • Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality Agreements, • Travel may be requiredREQUIREMENTS, • BS Degree in biological sciences or equivalent., • Minimum 5-10 years related experience in the pharmaceutical or biologics industry., • Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)., • Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc., • Sound knowledge of aseptic processing and supporting technologies., • Analytical and technical troubleshooting skills are a plus., • Proficient with Microsoft Office Suite., • Excellent organizational skills and attention to detail., • Good verbal and written communication skills., • Strong team-oriented interpersonal skills are essential., • Strong business acumen, • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task is essential, • Flexible and able to adapt to company growth and evolving responsibilitiesPlease 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.

Job DescriptionQuality Assurance Compliance InvestigatorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the (Associate) Manager of Quality Assurance (Floor support). Responsible to perform Quality Assurance Compliance activities in support of company and/or client procedures, including but not limited to, document. management: investigations, CAPA, SOPs, qualification and validation reports, QC data. Supports Quality management with various department, organizational and operational excellence initiatives. Generally, exercises independent judgment, within generally defined practices and policies, when selecting methods and techniques for obtaining solutions. This role supports internal and external audits which may include interaction with Health Authorities and clients. • Liaises with relevant functional groups (Operations, Facilitates, QC, EH&S) to conduct investigation and CAPA processes., • Conduct investigation and identify true root cause using appropriate tools., • Manage multiple investigations in different stages of the process to meet compliance deadlines and product release dates., • Reviews and approves investigations and CAPAs when required;, • Collaborate with cross functional department to develop and track CAPA plans., • Prepares and issues change control as necessary., • Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company’s processes and procedures., • Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations., • Conducts trend analysis of compliance related metrics such as deviations and CAPAs., • Performs supplemental investigations and/or participates in project teams or assignment as necessary., • Support in agency, internal and/or client audits., • Other duties as assigned.REQUIREMENTS, • B.S in biological sciences or other relevant field of study., • Minimum 5 years’ experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Familiar with FDA, ISO, and other regulatory agency guidelines., • Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required., • Working knowledge and technical understanding of aseptic manufacture of biologics preferred., • Experience in both clinical and commercial manufacturing is preferred., • Experience in supporting health authority inspections and/or client audits preferred., • Competencies/Candidate Profile, • Relevant computer skills (Microsoft Office, Outlook), • Detail-oriented and organized, • Analytical and problem-solving skills, • Good written and oral communication skills, • Ability to multi-task and be adaptable, • Flexible and able to adapt to company growth and evolving responsibilities, • Ability to work independently and with a team, • Strong Project Management and organization skills, • Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit., • Must be able to work in a team-oriented environment., • Must be able to work occasional weekends, nights, and/or holidays as required/necessary., • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids., • Must be able to handle the standard moderate noise of the manufacturing facility., • Must be able to work in open floor plan environment and may work in close proximity to others., • Wheel-o-Vator available for use. 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.

Job Description We are seeking a highly motivated individual to join us as a Quality Assurance Manager. This individual will have the responsibility for Quality aspects related to Quality Systems in the packaging facility. The Quality Assurance Manager will ensure compliance with current Good Manufacturing Practices (cGMP) as they pertain to the local regulation and exporting countries regulation as applicable (such as FDA, MHRA, EMA, Health Canada). Overall Responsibilities For Quality Operations And Initiatives, Including • Quality Assurance management:, • Documentation control (master batch record, specification and method), • Batch record review and product disposition, • Investigations, complaints, deviations, CAPAs, APRs, • Production and Pharmaceutical Development support, • APRs, GMP training and SOP review, • Validation / qualification documentation review and approval, • QA Operations - inspection, sampling, and review of incoming materials, perform AQL inspections, support and drive compliance throughout the site, • Develop, maintain, and enhance training programs and systems, • Driving key compliance initiatives such as, Training Program Enhancements, Quality Documentation System Enhancements, other identified initiatives., • Must be able to move about the facility, • Experience with FDA Audit, • Extensive knowledge of US and EU current Good Manufacturing Practices, • Experience with a CDMO would be preferable, • In collaboration with the Quality Assurance team, the Quality Assurance Manager will be responsible for: i). Quality Compliance management: ii). All audits, internal, external - regulatory, client and vendor iii). Vendor management program iv). QA Agreements with clients & contractors v). License renewals Company DescriptionWe are a pharmaceutical packaging company looking for someone who is proactive and will to learn and grow..We are a pharmaceutical packaging company looking for someone who is proactive and will to learn and grow..

Job Description Job Description One of the nation’s largest independent testing facilities seeks a Stability and Study Coordinator with a minimum of 2 years stability systems experience in a GMP environment. The perfect candidate will also have previous experience as an Analytical Chemist with a minimum 2 years experience testing products for the pharmaceutical, nutritional cosmetic, personal care, medical device or allied industries. The position requires a working knowledge of testing products in a GMP regulated facility. Must have the technical ability to understand client requirements, technical documentation, and be able to prepare testing protocols. Responsibilities include, but are not limited to the following: • Communicates with clients regarding studies to ensure timely processing and submission to the laboratories., • Entry of stability studies and all associated information into company software system and communicates the stability testing schedules to department management., • Performs time point pulls within the acceptable guidelines and documents details as per SOPs, customer and regulatory requirements., • Submission of the stability samples to the appropriate departments., • Develops and generates stability study protocols according to customer requirements and timelines, internal SOPs and regulatory requirements., • Compilation of time point raw data and verification of results entry into stability system as well as generation of interim and summary time point data and reports., • Prepares the generation of shelf life summary reports for products based on compiled data., • Coordinates with department management regarding stability workload and schedules to ensure timelines are met., • Preparation of sample shipments and paperwork for returned samples., • Entry of routine, development and validation studies and all associated information into company software system and communicates the study details to department management., • Documents work clearly and accurately., • Perform technical writing and peer review as needed, • Capable of working in a fast paced environment. Education and Experience • Bachelor's degree in chemistry or other related degree, preferred., • Minimum 2 years of stability systems experience in a GMP laboratory., • Minimum 2 years of product testing experience in a GMP laboratory., • ISO 17025 experience a plus., • Excellent scientific and organizational skills., • Strong communication skills (written and oral) with an attention to detail., • Ability to learn new techniques, multitask, follow instructions and comply with SOPs., • Self motivated and have the ability to work independently and as part of a team., • Ability to stand/sit in office and laboratory environment., • Ability to use a personal computer and Microsoft Office (Word, Excel, Outlook) experience required., • Vision accuracy and color detection are required for this position, • Ability to wear/use personal protective equipment as required such as lab coat, goggles, gloves, masks, etc., • Ability to lift up to 30 lbs. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age or any other characteristic protected by law. Company DescriptionConsumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.Consumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.

Job DescriptionSupplier Quality AuditorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Supplier Quality Auditor ensures and promotes compliance through external auditing of company's suppliers; vendors/ laboratory services/service providers/manufacturers for the Allendale, NJ and Mountain View, CA sites based on company's procedures and external regulatory requirements, including but not limited to current FDA Quality System Regulations; 21 CFR Parts 210/211 (cGMP), 21 CFR Part 1271 (GTP), 21 CFR Parts 50/54/56/312 (GCP), 21 CFR Pat 58 (GLP), ICH Q7, Q9, Q10, 21 CFR Part 11 and Data Integrity and Eudralex Volume 4 Guidelines.The Supplier Quality Auditor position will be responsible for the development of a risk-based auditing program for company and management of the Approved Supplier List. The Supplier Quality Auditor will conduct external supplier/vendor/manufacturer audits and harmonize the supplier qualification process across all sites. The Supplier Quality Auditor supports qualification initiatives, continuous improvement, and regulatory compliance across all sites. • Develop and maintain a risk-based external auditing program for company harmonized across all sites., • Perform GAP analyses of the Approved Supplier List (ASL) of suppliers used at all company facilities to ensure complete profile., • Management of ASL to add suppliers and maintain approval status of all suppliers as needed., • Based on ASL status, conduct reviews and perform audits to qualify each supplier used., • Prepare external audit schedule and conduct audits per the schedule., • Prepare and complete audit reports and communicate audit information to cross functional teams within company and supplier within a timely manner., • Ensure adequate CAPAs are developed by suppliers and monitor CAPA closures., • Track audit findings for suppliers to completion and ensure timely closure of audit reports., • Act as a quality lead and liaison between suppliers and internal teams to identify new suppliers and identify and communicate issues that may impact quality, system gaps or cause interruptions in business continuity., • Maintain metrics on supplier audit findings used for oversight, qualification status, continuous improvement, and/or opportunities for reduction/alternate suppliers., • Maintain audit files and ensure all files are properly archived., • Author and review External Auditing, Supplier Qualification and Supplier Management Program and/or Quality Systems SOPs, as needed., • Ensure that Quality Agreements are generated and enforced at each supplier., • Ensure and promote compliance with applicable regulations (e.g., cGMPs, GTPs, etc.) and company and client SOPs., • Assist in other Quality System related responsibilities and provide Quality related support to various departments, as needed.REQUIREMENTS, • Minimum 5-8 years quality systems auditing experience in pharmaceutical, biologics, or medical device industry., • Auditor qualifications and certifications such as Certified Quality Auditor (CQA)/ASQ Certification, ISO Certification, etc., • Experience with auditing raw materials/excipients, components, and analytical and micro laboratories., • Proven ability to identify, collaborate, and resolve supplier related compliance issues., • In-depth knowledge and understanding of current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), ICH Q10, 21 CFR Part 11, Good Tissue Practices (GTPs) and Data Integrity principles,, • EU and PMDA regulations knowledge and associated guidelines are a plus., • Bachelor’s Degree in the chemistry or biological sciences, engineering, or life sciences., • Certified Auditor or Lead Auditor credentials required., • Understanding of the manufacture and testing of cellular and gene therapies is desirable., • Working knowledge of routine laboratory operations, equipment and systems, production processes, and validation., • Experience in Quality Assurance, including the ability to identify and resolve compliance issues., • Sound knowledge of aseptic processing and supporting technologies., • Must have exceptional written and oral communication skills., • Exhibit professional mannerisms when dealing with Clients/Suppliers and company personnel, • Ability to multi-task is essential., • Proficiency with IT skills, such as MS Office (Word, Excel, Outlook, PowerPoint) and SharePoint., • Ability to think strategically and tactically (strong detail-oriented)., • Strong collaborative and influencing skills and ability to work well in a cross-functional, team matrixed environment as well as independent contributor., • Strong analytical and problem-solving skills., • Flexible and able to adapt to company growth and evolving responsibilities., • Multi-disciplinary knowledge across GxP functional areas., • Excellent organizational skills including efficiency, punctuality and attention to detail and managing multiple priorities., • Good verbal, written communication, and presentation skills., • Demonstrable multitasking, project management, and execution skills., • Good business acumen and strong team-oriented interpersonal skills, including communication, presentation, negotiation, influence., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to handle the standard/moderate noise of the manufacturing facility, • Travel required (approx. 50%)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.

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.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.

Job DescriptionDescription: Under the direct supervision of the Chief Medical Officer, the Optometrist provides direct clinical care to patients at the health center. The Optometrist is a member of the Care Team with the purpose of providing evidenced-based and quality medical care to Zufall Health Center patients. Essential Functions, Duties, and Responsibilities • Provides eye care services for patients of Zufall Health, including but not limited to comprehensive eye examinations, diagnosis and management of ocular diseases, prescription of corrective lenses (if applicable), referral to ophthalmologists or other specialists when appropriate, and other duties as assigned. Ensures continuity and quality of patient care., • Leads and collaborates with assigned clinical support staff to deliver exceptional and accessible preventive, acute, and chronic eye care to a diverse patient population. Educates patients and families about eye health and vision care., • Participates in extended service hours including occasional evenings or weekends as scheduled. Adjusts availability as needed to support patient demand and clinic operations., • Assists patients in obtaining additional services such as low vision aids, specialty referrals, or surgical consultations. Works closely with the Chief Medical Officer to build relationships with external providers, optical labs, and vision care networks to enhance patient access and care coordination., • Participates in clinical quality improvement initiatives and peer chart reviews as assigned. Attends and contributes to regular medical staff and team meetings as deemed necessary by leadership., • Supports clinic operations by maintaining compliance with all applicable local, state, and federal regulations. Ensures that licensure, certifications, and continuing education requirements are current. Adheres to and helps refine clinical protocols and practice guidelines., • Participates in community outreach including vision screenings, health fairs, and educational workshops. Supports staff training, mentorship, and may precept optometry students or interns as needed., • Maintains professional affiliations and stays informed of advancements in optometric care, techniques, and public health concerns. To perform successfully, the individual must be able to perform the essential duties satisfactorily. The requirements below are representative of the knowledge, skill and ability required. • Doctor of Optometry (OD) degree from an accredited optometry school., • Strong verbal and written communication skills., • Ability to work effectively with a diverse range of patients and colleagues., • Flexibility and commitment to working variable hours as required to meet clinic needs., • Proficiency with EHR systems and general computer applications including Microsoft Word and Excel., • Bilingual and/or bicultural candidates are highly valued; ability to speak both English and Spanish strongly preferred., • Doctor of Optometry (OD) from a program accredited by the Accreditation Council on Optometric Education (ACOE)., • Active license to practice optometry in the state of New Jersey, in good standing., • Certification to use therapeutic pharmaceutical agents (TPA) as required by New Jersey regulations., • National Provider Identifier (NPI) and eligibility to participate in Medicare, Medicaid, and other health programs., • Current BLS certification; other certifications (e.g., Advanced Procedures, Low Vision) may be preferred depending on clinic scope., • Minimum 1 year of post-graduate clinical experience preferred; new graduates with strong clinical training may be considered.

Job Description Why Join the HWP Group? Health & Wellness Partners, LLC (HWP), is a medical and scientific communications agency that collaborates with life science industry stakeholders to develop award-winning solutions that advance patient care and transforms scientific content into compelling live and virtual user experiences through digital platforms, congress engagement, and more. We bring clients, providers, and patients outstanding educational programming paired with innovative digital and interactive dissemination vehicles. We are committed to making a difference in health care and in the lives of our team members. We aim to provide every employee with a job they love in a culture focused on career growth, well-being, and community outreach. We have been recognized as both an MM&M Best Place to Work and an Inc. Best Workplace. For more information, visit thehwpgroup.com. What You Need to Know We’re seeking an experienced Account Director to join our Account Services team—someone who excels at cultivating lasting relationships with clients and key opinion leaders. In this role, you’ll partner closely with clients to translate their strategic goals and tactical plans into impactful projects, while guiding internal teams to deliver exceptional results. You’ll lead cross-functional collaboration and oversee the daily operations within the agency, ensuring all deliverables align with client objectives, timelines, and budgets. What You’ll Do • Lead Project Execution: Manage projects from planning through delivery, acting as the central liaison between internal teams, external vendors, and stakeholders to ensure clarity around deliverables, timelines, budgets, and strategic goals., • Schedule & Risk Management: Communicate project schedules and updates to all stakeholders. Monitor progress to identify potential risks and implement mitigation strategies proactively., • Project Tools & Tracking: Utilize project management platforms to build and maintain timelines, tasks, milestones, and deadlines., • Team Alignment: Facilitate project meetings to ensure cross-functional teams are aligned on methodology, goals, and progress tracking., • Resource Allocation: Manage project resources within budget, flagging scope changes or out-of-scope requests to the Account Lead and client., • Documentation & Budgeting: Develop materials, statements of work (SOWs), program budgets, and reconciliations with precision and clarity., • Team Development: Support onboarding and training of Managers and Coordinators. Delegate tasks and oversee execution to ensure quality and timely delivery., • 3-5 years of account/project direction experience within a medical communications or medical advertising agency., • Familiarity with medical terminology and pharmaceutical products and knowledge of regulations and program implementation procedures, • High level of business acumen, financial awareness and negotiation skills, • Client intimacy mindset, • Experience in end-to-end project development, from ideation through implementation, • Proven ability in organic business development, including crafting tactical recommendations, • Expertise in Scope of Work (SOW) development and management, • Excellent oral and written communication and time management skills, • Proven strong interpersonal skills and the ability to participate constructively and effectively in meetings with a clear understanding of individual action items, • Proactive problem-solving skills in communications with internal teams and clients, • Proficiency in Microsoft® Office Suite, • 100% employer-paid medical, dental, and vision insurance, • 401k plan employer matching, • Eligibility for profit sharing, • Generous PTO, including a week off in December for the holidays, • Paid volunteer time off, • Tuition reimbursement, • On-site gym and other employee wellness initiatives, • Casual work attire, • Comprehensive mental health services, • Leadership development training program and other career development programs, • Flexible hybrid and remote work schedule options

Job DescriptionCOMPANY OVERVIEW: At F.P. Developments, Inc., we recognize that our employees are our greatest asset. We foster a supportive environment where each team member’s unique strengths and perspectives are valued. Our state-of-the-art, 25,000 sq. ft. climate-controlled facility is a hub for innovation and collaboration, empowering our team to grow both personally and professionally. For 60 years, F.P. Developments has been a cornerstone in the pharmaceutical, biotech, and medical device industries. Established in 1963, we leverage the latest technologies and good old-fashioned ingenuity to solve today’s manufacturing and compliance challenges, consistently meeting our customers' specific requirements with precision and dedication. Join us and be a part of a legacy of quality and innovation. F.P. offers full medical, dental and vision benefits as well as 401k matching, holidays and PTO. SUMMARY: As an Electromechanical field service technician at F.P. Developments, you will train and assist in the fabrication, assembly, electrical wiring, controls programming and servicing of machines and robots used in primary pharmaceutical manufacturing and hospital pharmacy compounding. You will be a self-starter, a quick learner, and open to advancement and travel opportunities. You will also participate in our innovation process, offering suggestions around new capability development. THIS POSITION REQUIRES 10-15% TRAVEL ANNUALLY DUTIES AND RESPONSIBILITIES: • Assembling machines and robots:, • Utilize electrical and mechanical blueprints and schematics to assemble large and small machinery, • Collaborate with engineering and fabrication staff to ensure high quality, durable construction, • Analyze controls programming for PLC and robot automation to troubleshoot and simplify code structure, • Servicing and refurbishing machines and robots (onsite and in the field):, • Troubleshoot and fix machine issues across mechanical, electrical and controls, • Identify and document preventative maintenance procedures for new machines, • Inspect mechanical components for wear and electrical panels for loose and missing components and recommend necessary fixes, • Replace worn or missing parts and ensure machine functionality, • Innovation support, • Research issues and recommend potential solutions, • Stay up to speed with new and emerging technologies applicable to our products, • Education:, • High school diploma or equivalent with electromechanical and controls programming experience OR, • Electrical engineering undergraduate experience, • Skills:, • Mechanical aptitude, • Basic understanding of electrical schematics/wiring, • Basic understanding of PLC programming, • Follow through and follow up, • Strong organizational skills with the ability to manage multiple tasks effectively, • Attention to detail, ensuring all tasks are completed accurately and on time., • Ability to manage time effectively and prioritize tasks in a fast-paced environment, • Customer Service: Exceptional customer service skills with a focus on clear, effective communication and responsiveness to customer inquiries and needs, • Attention to Detail: Meticulous in checking and confirming all aspects of logistics operations, including deliveries, shipments, and inventory, • Openness to Feedback: Highly receptive to feedback, seeking continuous improvement and adjusting based on input from colleagues and customers, • Teamwork: Strong team player, able to collaborate effectively with multiple departments and contribute to a positive work environmentPHYSICAL DEMANDS AND WORK ENVIRONMENT:, • Continually required to stand, walk, sit, • Continually required to utilize hand and finger dexterity, • Occasionally required to climb, balance, bend, stoop, kneel or crawl, • Continually required to talk or hear, • Occasionally required to lift/push/carry items up to 100 pounds, • Frequently required to work near moving mechanical parts and always observe safety precautions, • Ability to travel and work independently The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Powered by JazzHR 79RT1ysAW4

Job Description One of the nation’s largest independent testing facilities seeks an Analytical Chemist with a minimum 2 years' experience testing products for the pharmaceutical, nutritional cosmetic, personal care, medical device or allied industries. The position requires a working knowledge of testing products in a GMP regulated facility. Responsible for performing physical, chemical and instrumental techniques on APIs, raw materials and finished products according to schedule. Must have the technical ability to understand client requirements and assist in the preparation of testing protocols. • Run instrumentation such as, but not limited to: ICP-MS, HPLC, GC,UV, IR, AA, DSC, KF on products according to compendial, client and internal methodologies., • Prepare standards and samples for analysis., • Perform physical, chemical and instrumental techniques on APIs, raw materials and finished products., • Execute method transfer and validation protocols., • Document work clearly and accurately., • Perform technical writing and peer review as needed., • Operates and maintains laboratory equipment and instrumentation required for cGMP analysis of samples., • Bachelor's degree in chemistry or other related degree, preferred., • Minimum 2 years of product testing experience in a GMP laboratory., • ICP-MS/OES experience required., • Previous data acquisition software (Totalchrome, Empower, etc.) experience required., • Excellent scientific and organizational skills., • Strong communication skills (written and oral) with an attention to detail., • Ability to learn new techniques, multitask, follow instructions and comply with SOPs., • Self motivated and have the ability to work independently and as part of a team., • Ability to stand/sit in office and laboratory environment., • Ability to use a personal computer and Microsoft Office (Word, Excel, Outlook) experience required., • Vision accuracy and color detection are required for this position, • Ability to wear/use personal protective equipment as required such as lab coat, goggles, gloves, masks, etc., • Ability to lift up to 30 lbs.Company DescriptionConsumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.Consumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.

Participate in the qualification/validation campaign for new radiopharmaceutical process implementation according to GMP standards. Maintain a clean and safe working environment in compliance with hazardous material safety and pharmaceutical regulation. Essential Duties and Responsibilities Operate,

Job DescriptionJob Title: Full Time Pharmacist Position Type: Full-Time (Immediate Joining Preferred and Available to work weekends) Job Description: Icare Pharmacy Plus is seeking a dedicated and highly skilled Pharmacist to join our team. We are looking for a professional who can dispense medications accurately, provide excellent pharmaceutical care, and ensure compliance with all relevant laws and regulations. If you are motivated and committed to excellence in patient care, we encourage you to apply. Candidates available for immediate joining are preferred. Key Responsibilities: • Medication Dispensing: Accurately dispense prescription medications to patients., • Patient Counseling: Provide detailed counseling on medication usage, potential side effects, and interactions., • Regulatory Compliance: Ensure adherence to federal, state, and local pharmacy regulations., • Controlled Substances Management: Maintain accurate records and manage controlled substances responsibly., • Staff Training: Oversee and train pharmacy staff to ensure adherence to best practices., • Collaborative Care: Work with healthcare providers to manage and improve patient care., • Inventory Management: Maintain optimal inventory levels to prevent shortages and overstock., • Insurance Processing: Handle insurance claims processing and reimbursement efficiently., • Customer Service: Address and resolve patient inquiries and concerns professionally. Job Requirements: • Must Have: A valid state required pharmacist license, • Must Have: Doctor of Pharmacy (Pharm.D.) degree from an accredited institution., • Preferred: Minimum of 3-5 years of experience in a pharmacy setting. Skills: • Strong knowledge of federal and state pharmacy laws and regulations., • Proficiency with pharmacy management software systems., • Excellent communication and interpersonal skills., • Ability to work efficiently in a fast-paced environment., • Strong attention to detail and organizational skills., • Commitment to providing exceptional patient care. Preferred Qualifications: • Certification in Medication Therapy Management (MTM)., • Experience with inventory management and cost-saving measures., • Proven track record of effectively managing a pharmacy team. Benefits: • Performance-based bonus, • Competitive salary, • Paid time off, • Training and development opportunities, • Wellness resources Why Join Us: • Supportive Environment: Be part of a team that values and supports your contributions., • Growth Opportunities: Advance your career with opportunities for professional development., • Balanced Schedule: Maintain a healthy work-life balance with our balanced work schedules., • Competitive Packages: Benefit from competitive salary packages and growth opportunities. We look forward to reviewing your application. Icare Pharmacy Plus is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Job Description Overview Amerita, Inc. is a leading provider in home Infusion therapy. We are looking for a Pharmacy Technician - Compounding to join our Pharmacy team as we grow to be one of the top home infusion providers in the country. The Pharmacy Technician will report to the Pharmacy Manager and work in our City, State branch. Amerita is an entrepreneurial-founded company and a wholly owned subsidiary of PharMerica. The home infusion market is positioned for rapid growth driven by the aging population, increase in chronic diseases, robust pipeline of infusible drugs coming to market, and an industry shift from hospital delivery settings to lower-cost, high-quality alternative providers such as Amerita. As a core member of the Pharmacy team, you will be expected to prepare technical and clerical tasks associated with the preparation, labeling and dispensing of pharmaceuticals. We will help you achieve your goals through continuous professional development and regular career progression discussions. Schedule: Tuesday - Friday 12:00pm - 8:00pm Saturday 10:00am - 4:00pm • Competitive Pay, • Health, Dental, Vision & Life Insurance, • Company-Paid Short & Long-Term Disability, • Flexible Schedules & Paid Time Off, • Tuition Reimbursement, • Employee Discount Program & DailyPay, • 401k, • Pet Insurance Responsibilities • Coordinates and schedules the preparation of sterile mixtures and home medical equipment orders with the assistance of the Pharmacist, • Completes all calculations on product preparation as necessary, • Compounds sterile mixtures and non-mixtures, including, but not limited to parenteral nutrition, antibiotics, chemotherapy, hydration and narcotic analgesics, using aseptic technique where state laws permit, • Ensures compounding/clean room areas and related equipment are cleaned, sanitized and maintained in compliance with company policies and procedures, and USP 797 and USP 800 standards, • Documents all activities on appropriate logs, • Participates in branch management, department and intra-departmental meetings and quality improvement activities, • Adheres to all accreditation, OSHA, FDA, state, local and federal regulations, and USP 797 and USP 800 standards relevant to infusion pharmacy and home medical equipment, • Documents all temperature logs, pressure and humidity monitors, records all sterility testing done in the clean room in compliance with company policies and procedures, and USP 797 and USP 800 standards, • Documents all activities on the appropriate logs, • Other duties as assigned Supervisory Responsibility: No Qualifications • Successful completion of an approved/accredited Pharmacy Technician training program; IV certification preferred, • Registered Pharmacy Technician license in state of practice per state regulations, • National Pharmacy Technician Certification as required by the state board of pharmacy in state of practice, • 1-3 years of related pharmacy experience in a home care setting, retail or pharmacy setting, preferred, • At least 1 year of aseptic preparation of infusion-related pharmaceuticals in a hospital or home infusion setting preferred, • General knowledge of drug terminology, pharmaceutical calculations, drug use and aseptic techniques, • Flexible schedule with the ability to work on-call evenings and weekends on an as-scheduled basis, • Effective mathematical and communication skills required, • Basic pharmacy knowledge of reading and interpreting prescriptions, • Ability to work independently, accurately and efficiently, • Valid driver's license Driving Position: Yes-Minimal driving for patient deliveries may be required To perform this role will require constant sitting and typing on a keyboard with fingers, and ocassionally standing and walking. The physical requirements will be the ability to push/pull and lift/carry 21-30 lbs

Job Description Job purpose To ensure the safety, efficacy, and affordability of medications prescribed by providers. Description of the duties and responsibilities Pharmacy technicians are responsible for performing the technical tasks involved with the storage and distribution of medication samples to patients during visits. Communicate with pharmaceutical representatives to maintain medication samples and reordering. Assists providers in reviewing and refiling medications, maintaining the drug inventory and patient records, and completing required documentation of tasks. Facilitates prior authorizations and medications changes with the pharmacy and provider to ensure medication affordability for the patient. Works under the direct supervision of the pharmacist and/or provider to educate patients on the importance of medication compliance and assist providers in medication reconciliation. Positions available include full-time position. Shifts available include: 9A - 5P and 10A - 6P, hours may be flexible. Knowledge Qualifications: • Excellent working knowledge of drug names, dosages, and dosage forms (Preferred), • Knowledge of computer applications such as Microsoft Office (Outlook, Word, Excel, Calendar) is preferred., • Understanding of medication sig abbreviations and drug interactions (Preferred) Skill and Ability Qualifications: • Time management, • Detail orientated, • Personable, • Composure, • Professional Preferred Qualifications: • Work requires a High School diploma or equivalent and pharmacy experience is required., • Registration by the Board of Pharmacy as a Registered Pharmacy Technician is required., • New hires have 3 months from date of hire to obtain registration., • PTCB certification is preferred but not required.

Job DescriptionFull job description At J&J Pharmacy we are seeking a highly skilled and experienced Pharmacist in Charge to join our team. As the Pharmacist in Charge, you will be responsible for overseeing the daily operations of the pharmacy department and ensuring the safe and effective use of medications. Your expertise and leadership will play a crucial role in providing exceptional patient care and maintaining compliance with all regulatory requirements. Responsibilities: • Manage and supervise the pharmacy staff, including pharmacists, technicians, and support personnel, • Ensure compliance with all federal, state, and local laws and regulations governing the practice of pharmacy, • Ensure accurate dispensing of medications and adherence to proper procedures while overseeing compounding and labeling processes, • Develop and implement policies and procedures to maintain compliance with state and federal regulations, • Collaborate with healthcare providers to optimize patient care and medication therapy management, • Provide drug information to healthcare professionals and patients, • Conduct medication utilization reviews to identify opportunities for improvement, • Monitor patient outcomes and make recommendations for therapy adjustments as needed, • Participate in medical management activities, including formulary management and medication utilization reviews, • Maintain aseptic technique in sterile compounding areas, • Provide clinical support in acute care settings such as the emergency room (ER) and intensive care unit (ICU), • Demonstrate proficiency in medical terminology and patient service, • Monitor medication inventory levels and order medications as needed, • Maintain accurate patient records and documentationQualifications:, • Doctor of Pharmacy (Pharm.D.) degree, • Current state pharmacist license in good standing, • Must have Immunization License, • Previous experience as a licensed pharmacist, • Strong knowledge of pharmacology, physiology, and drug interactions, • Leadership and management skills, • Excellent communication and interpersonal skills to effectively collaborate with healthcare professionals and patients, • Attention to detail and commitment to patient safety, • Knowledge of pharmaceutical compounding and medication therapy management, • Proficiency in medication administration, including IV infusion and pain management, • Prior Auth experience preferred, • Compounding experience a plusJob Type: Full-time Pay: $55.00 - $60.00 per hour Benefits: • 401(k) matching, • Medical Insurance, • Dental Insurance, • Vision Insurance, • On-site Training, • Wellness Resources, • Employee Discount, • Paid time offSchedule:, • Monday to Friday, • Weekends as needed, • 40 hours a weekLicense/Certification:, • Licensed Pharmacist (Required)Ability to Commute:, • Teaneck, NJAbility to Relocate:, • Teaneck, NJ: Relocate before starting work (Required)Work Location: In person