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Associate, In-Process QA, MG/PG

hace 13 días

North Brunswick

Job Description Job Description Date 06/2025 Location 1300 Airport Road, North Brunswick NJ 08902 Title Associate, In-Process Quality Assurance MFG/PKG Department Quality Assurance Operation Support Reports to Quality Assurance Manager/ VP of QA FLSA (Exempt or Non-Exempt Non-Exempt Role Overview The IPQA performs line inspection as part of the cGMP, SOPs, and policy compliance requirements as per CFR part 111. Performs In-process quality testing in manufacturing and/or packaging areas according to prescribed timelines and accurately captures test results in batch records. The Inspector performs calibrations & measurements on raw materials, bulk products, finished products and packaging components as required in batch records and SOP’s. This position reports to the QA Manager and is a key member of the Quality Assurance group. The IPQA Associate is a highly organized self-starter who can work independently, demonstrates a positive attitude, and a bias for action. Areas of Responsibility IPQA – Level 1: To support In-process quality assurance activities by performing routine checks and verifications during manufacturing and/or packaging of nutraceutical products. This role ensures that all processes comply with applicable GMP, SOPs, and regulatory requirements. Key Responsibilities: ???? Manufacturing Support • Perform line clearance before starting blending, granulation, compression, encapsulation, coating processes., • Perform In-process checks:, • Blend uniformity sampling, • Tablet/capsule weight variation, • Hardness, friability, and disintegration tests etc as applicable, • Verify equipment cleaning and area hygiene as per SOP., • Ensure line clearance before packaging activities., • Perform In-process checks:, • Batch number and expiry date printing, • Label application and carton sealing, • Primary and secondary packaging integrity etc as applicable, • Record observations in IPQA checklists, logbooks, and batch records., • Maintain GMP documentation in real-time (legible and error-free)., • Adhere to company GMP, SOP, and Hygiene policies., • Use PPE appropriately., • Support during internal/external audits by providing necessary records., • Cleans up work following the completion of a shift., • Meets all safety expectations and follows all safety practices., • Works extended hours and occasional weekend overtime., • Other duties as assigned, • Other Responsibilities Including Safety: IPQA – Level 2: To independently perform and document In-process quality assurance activities at all critical stages of manufacturing and packaging of nutraceutical products, ensuring compliance with GMP, SOPs, and regulatory requirements. Key Responsibilities: ???? Manufacturing Stage (Granulation, Blending, Compression, Encapsulation, Coating ) • Carry out and document line clearance activities before starting each manufacturing batch., • Conduct in-process checks independently:, • Blend uniformity sampling, • Tablet/capsule weight variation, • Hardness, friability, thickness, and disintegration, • In-process controls as per BMR specifications, • Verify equipment cleanliness status, calibration, and logbook entries., • Conduct line clearance for primary and secondary packaging (bottles, strips, blister, cartons)., • Perform and document:, • Batch coding verification (batch no., Mfg/Exp date), • Packaging material correctness (labels, leaflets, cartons), • Sealing integrity checks (blisters, induction seals), • Online rejection bin and reconciliation checks, • Fill Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) in real-time., • Record IPQA observations and results as per SOPs ( legible and error free)., • Initiate and report deviations, OOS/OOT, and non-conformities to QA Supervisor/ Manager., • Ensure compliance with GMP, GLP, and data integrity principles., • Follow gowning protocols, hygiene, and safety measures in production areas., • Assist during internal audits and regulatory inspections by providing accurate documentation and data., • Cleans up work following the completion of a shift., • Meets all safety expectations and follows all safety practices., • Works extended hours and occasional weekend overtime., • Other duties as assigned, • Other Responsibilities Including Safety: IPQA – Level 3: To lead and monitor In-process QA activities during nutraceutical manufacturing and packaging operations. Ensure compliance with GMP, regulatory standards, and internal SOPs by supervising IPQA teams, reviewing records, and addressing quality deviations. Key Responsibilities: ????IPQA Oversight – Manufacturing & Packaging • Supervise and verify line clearance activities across all manufacturing and packaging areas., • Ensure compliance with critical process parameters (CPPs) and critical quality attributes (CQAs)., • Review and approval:, • In-process checks: weight variation, hardness, friability, disintegration etc as applicable, • Environmental monitoring records, • Equipment and area cleaning records, • Review and verify completed Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR)., • Cross-check reconciliation of raw materials and printed packaging materials., • Investigate and document process deviations, non-conformances, and OOS/OOT incidents., • Lead root cause analysis (RCA) and implement Corrective and Preventive Actions (CAPA)., • Ensure readiness for internal, external, and regulatory audits (FSSAI, WHO-GMP, USFDA, etc.)., • Conduct routine GMP audits, spot checks, and area inspections., • Guide and mentor IPQA Level 1 and Level 2 personnel., • Allocate daily QA responsibilities and monitor adherence to QA procedures., • Conduct on-the-job training for new team members, • Cleans up work following the completion of a shift., • Meets all safety expectations and follows all safety practices., • Works extended hours and occasional weekend overtime., • Other duties as assigned, • Other Responsibilities Including Safety:, • Meets all safety expectations and follows all safety practices., • Works extended hours and occasional weekend overtime., • Other duties as assigned, • Other Responsibilities Including Safety:, • N/A Other Responsibilities Including Safety: • Works in a safe and responsible manner to create an injury-free and incident-free workplace., • Complies with all job-related safety and other training requirements. Education & Qualification: IPQA – Level 1: • 0–1 year (Freshers with training or internship in QA preferred), • Or equivalent combination of education and experience., • High School diploma is required; BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus. IPQA – Level 2: • Minimum of 3+ years of experience in a QA Inspector within a nutritional’s supplements, food, consumer products or pharmaceutical company., • Or equivalent combination of education and experience., • BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus. IPQA – Level 3: • 3–5 years in IPQA or related QA roles in nutraceuticals, pharmaceuticals, or food manufacturing. Or equivalent combination of education and experience. IPQA – Level 1: • Basic understanding of GMP, nutraceutical processes, and QA principles., • Good observation and attention to detail., • Willingness to work in production areas (shifts, growing zones)., • Ability to follow instructions and standard procedures accurately., • Basic proficiency in English and documentation practices. IPQA – Level 2: • Strong knowledge of IPQA functions, SOPs, and process flow in nutraceuticals., • Understanding of basic analytical parameters (weight variation, friability, etc.)., • Good documentation and observational skills., • Proficient in using basic lab and QA tools (weighing balances, disintegration testers)., • Familiar with regulatory guidelines (FSSAI, WHO-GMP, USFDA, HACCP). IPQA – Level 3: • In-depth understanding of nutraceutical manufacturing processes and regulatory compliance., • Proficient in QA documentation, process audits, and deviation handling., • Strong analytical and decision-making skills., • Familiar with QMS tools, GMP documentation, and data integrity principles., • Working knowledge of SOP writing, change control, and risk assessment. Physical Requirements (lifting, etc.): • Ability to lift up to 35 lbs.; occasionally lift and move up to 50 pounds., • Must stand and walk on production floor a minimum of 6 hours per shift, • Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from waist, or squatting, walking short distances., • Occasionally works from a rolling ladder or step stool., • Work is regularly performed inside a manufacturing and packaging environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship. USPL is proud to be an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law. Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment. shift schedule 1st shift: 7:00 AM - 3:30 PM, 2nd shift: 3:00 PM - 11:30 PM and 3rd shift: 11:00 PM - 7:30 AM 3rd Shift 11:00 PM to 7:30 AM

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