Associate, In-Process QA, MG/PG

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:

Requirements

Education & Qualification:

IPQA – Level 1:

IPQA – Level 2:

IPQA – Level 3:

Certifications, Licenses, Credentials:

Skills & Ability

IPQA – Level 1:

IPQA – Level 2:

IPQA – Level 3:

Physical Requirements (lifting, etc.):

• Must be able to wear all PPE including lab coat, face mask, booties, gloves, safety glasses.

Work Environment (Office, Warehouse, temperature extremes, etc.):