This position ensures compliance with cGMP standards under Section 503B of the US Food, Drug & Cosmetic Act. The QA Manufacturing Specialist provides quality oversight for manufacturing and production activities including compounding, filling, inspecting, and packaging. Responsibilities include monitoring in-process activities such as cleaning, weighing, aseptic filling, material verification, batch record accuracy, and room/line clearances.
Position Responsibilities
- Provide quality oversight of production activities including compounding, aseptic filling, inspection, and labeling/packaging on the floor.
- Ensure compliance with cleaning protocols.
- Review and approve product labels.
- Confirm compliance with filling operations and documentation.
- Verify proper gowning and aseptic technique.
- Generate deviations, CAPAs, and change controls as needed.
- Oversee quality aspects on the production floor.
- Participate in regulatory audits.
- Assist with root cause analysis.
- Document monitoring activities and coordinate corrections.
- Perform duties in accordance with company policies.
Requirements
- 3-5 years progressive experience in cGMP quality operations, FDA regulations, 503B outsourcing, aseptic or parenteral manufacturing.
- High school degree required; BS in scientific field preferred.
- Strong knowledge of safety, quality systems, and assurance concepts.
- Familiarity with manufacturing processes, automation, and equipment.
- Ability to work independently and meet deadlines.
- Excellent communication and computer skills.
- Creative problem-solving and strong ethical standards.
- Flexible work schedule including possible weekends and shifts.
Work Environment and Physical Demands
- Cleanroom environment with gowning requirement.
- Physical activities including sitting, standing, walking, reaching, and occasional lifting of up to 25 pounds.
- Specific vision abilities needed such as close vision and depth perception.
Position Type and Hours
- Full-time position based in Ledgewood, NJ.
- Regular operations Monday through Friday with variable hours and potential weekend or holiday work.
