Associate, In-Process QA, MG​/PG

1300 Airport Road, North Brunswick NJ 08902

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

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.

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.

• 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.

• 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).

• 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.

• 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:

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.

• 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).

• 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…