Quality Assurance (QA) Documentation Supervisor (Mfg. & Pkg.)

We are seeking a highly organized, detail-oriented QA Documentation Supervisor (Mfg. & Pkg.)to lead our Quality Assurance documentation team and manage daily compliance operations. You will serve as the primary gatekeeper for all compliance documentation, ensuring strict adherence to cGMP guidelines, DEA regulations, and internal Standard Operating Procedures (SOPs).

Major Duties & Responsibilities

• Monitor, control, and maintain all Quality Assurance documentation, records, and systems.


• Perform QA review and final release of commercial pharmaceutical product batches in accordance with approved procedures, cGMP requirements, and applicable FDA regulations.


• Review complete Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), and associated documentation for completeness, accuracy, and compliance.


• Review and assess deviations, investigations, OOS/OOT results, and CAPAs associated with the batch prior to release.


• Maintain accurate and complete batch release and disposition records in accordance with Good Documentation Practices (GDP).


• Write, review, revise, and approve Standard Operating Procedures (SOPs), validation/transfer protocols, and equipment/instrument/utility qualifications.


• Review and approve master batch production records, batch manufacturing/packaging documents, and customer or shipping requirements.


• Handle Change Controls, Deviations, and Investigations according to established SOPs.


• Manage and resolve customer complaints effectively.


• Conduct regular internal audits to guarantee full compliance with SOPs and cGMP regulations and conduct routine training sessions across the facility.


• Plan, monitor, and coordinate daily schedules for incoming raw materials, in-process materials, finished products, and packaging/labeling sampling and inspection activities.


• Handle and maintain Quality Assurance samples of Schedule II–V controlled substances (raw materials and finished products).


• Supervise the issuance and control of reference listed drugs and market samples.


• Train, supervise, and mentor QA associates and inspectors to ensure strict adherence to SOPs and cGMP.


• Execute alternative QA tasks as assigned by the department head.

Qualifications

• Bachelor’s degree in chemistry, Pharmacy, Biology, or a relevant scientific discipline.


• 3–5+ years of QA experience in a regulated pharmaceutical, medical device, or biotech environment.


• Deep understanding of cGMP (21 CFR Part 210/211) and DEA regulations for controlled substances.


• Strong technical writing and editing capabilities to produce audit-ready SOPs and investigations.

PHYSICAL DEMANDS/ENVIRONMENTAL CONDITIONS:

• Ability to stand, walk, and sit for extended periods while conducting facility audits and supervising production floor activities.


• Must be able to wear required personal protective equipment (PPE) and successfully perform aseptic or controlled-environment gowning procedures as required by production areas.


• Ability to occasionally lift and move up to 25 lbs. of documentation boxes or product samples.