Associate, In-Process QA, MG/PG
2 days ago
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., • Collect and label In-process and stability samples under supervision. ???? Packaging Support • 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, • Assist in reconciliation of packaging materials (e.g., printed cartons, leaflets, labels). ???? Documentation • Record observations in IPQA checklists, logbooks, and batch records., • Maintain GMP documentation in real-time (legible and error-free)., • Escalate any deviation or abnormality immediately to the QA Executive/Supervisor. ???? Compliance & Safety • 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., • Monitor and record environmental conditions in production areas (temperature, RH, differential pressure). ???? Packaging Stage • 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, • Ensure correct usage of approved packaging materials with status labels. ???? Documentation & Compliance • 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., • Support CAPA implementation and change controls. ???? General QA Duties • 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, • Coordinate and monitor sampling activities for In-process, finished products and stability studies. ???? Review and Verification • Review and verify completed Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR)., • Cross-check reconciliation of raw materials and printed packaging materials., • Verify proper use of status labels (approved/rejected/quarantine). ???? Deviation & CAPA Management • Investigate and document process deviations, non-conformances, and OOS/OOT incidents., • Lead root cause analysis (RCA) and implement Corrective and Preventive Actions (CAPA)., • Coordinate with cross-functional teams (Production, QC, Regulatory Affairs) to ensure closure of quality events. ???? Audit & Compliance • Ensure readiness for internal, external, and regulatory audits (FSSAI, WHO-GMP, USFDA, etc.)., • Conduct routine GMP audits, spot checks, and area inspections., • Train shop-floor personnel on data integrity, documentation practices, hygiene, and gowning protocols. ???? Team Coordination • 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.
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