Job Functions:

• Full lifecycle review and disposition of parenteral manufacturing Batch Records (Formulation, Filling, Inspection, & Packaging) for Media Fills and Drug Product.
• Provide Client access and support in the review and approval of Batch Records.
• Provide training to all QA Associates and Specialists on surveillance oversight and on-the-floor Batch Record review requirements.
• Support Quality Systems with driving timely completion of batch impacting deviations to support on time batch release activities.
• Participate in operations investigations for determining root cause and assessing mitigation for Major and Critical deviating events.
• Support authoring, reviewing and approving of various SOPs & Work Instructions, also advise and approve the builds of Batch Record BOMs and ECOs.

Candidate Requirements:

• Bachelor’s Degree required; degree preferred to be in a related Science (Chemistry, Biology, Biochemistry, Microbiology etc.)
• 4 years minimum experience working in a GMP environment.
• 2 years minimum experience working with aseptic processing in cleanroom and/or isolator environments required.

Additional Preferences:

• 3 years experience as performer or reviewer in Quality Management Systems, DMS, Deviation/CAPA, and Change Control required.
• 2 years’ experience with assessment and review of Quality Control testing, CoA, and results management preferred.
• Extensive knowledge of regulations and quality processes involving product disposition.