SRG, the leader in the Life Sciences human capital industry, is looking for a full-time contract Product Quality Manager to join our client's pharmaceutical manufacturing team in Raleigh, NC OR Richmond, VA. This position will be hybrid onsite Tues- Thur.

MUST HAVES:

• Background in Quality Assurance
• Pharmaceutical Sterile Manufacturing - Must have worked in a sterile/aseptic manufacturing GMP facility with a strong understanding of the manufacturing process
• Batch record review for sterile products (vial or syringe filling - preferably syringe filling)
• Experience and knowledge of FDA and EU Guidelines and Annex 1
• Technologically adept, using MS Office Suite, Teams, comfortable using new technology and self-learning.
• Self-starter and able to learn quickly with minimal guidance and using experience and sound judgement
• Strong Deviations/Technical Writing skills
• Familiar with using VEEVA and TrackWise, D2

JOB RESPONSIBILITIES:

• Experience with FDA, EU, TGA, or other Health Authority inspections and supporting inspection readiness
• Must have experience working with and providing QA oversight to Contract Manufacturing Organizations / Contract Packaging Organizations / Third Party Logistics Providers
• Must have experience working with Supply Chain/Supply Planning and coordinating the release and shipment of batches
• Review of CPPs, COAs, review and critique of deviations, environmental monitoring data (viable, NVP, personnel), BMS data, autoclave printouts, CIP/SIP printouts, filter integrity test printouts, bill of material, API CofA, Excipient CofA, temperature data
• Must have reviewed secondary packaging records, serialization, AQL, temperature data, registered components
• Must be able to perform an impact assessment, perform the interview, perform the root cause analysis (via Ishikawa, 5-Why, 6M, etc.), perform a risk assessment, recommend CAPAs

* Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.