This position is responsible for performing Quality Assurance (QA) review of Contract Manufacturing Organization (CMO) manufacturing batch records and associated documentation. This includes receipt, QA review and archival of executed manufacturing batch records and associated documentation such as QC test forms, and updating QA databases. QA review of manufacturing batch records includes verifying conformance to cGMPs, SOPs and batch record process limits.
- The individual is expected to communicate well with CMO/Packaging Ops, Quality Assurance, Quality Control, Regulatory Affairs, and Supply Chain and CMOs.
- Perform QA review of Manufacturing executed batch records and associated documentation for compliance with cGMPs, SOPs, and other polices and procedures.
- Ensure adherence to company policies/procedures, regulatory licenses, applicable Quality and Technical agreements, industry standards, and GMP regulations.
- Receive, control, scan and archive CMO executed batch records.
- Prepare lot history folders for Drug Product (DP) lots.
- Update QA CMO datases/Oracle EBS
- Obtain data for complaint investigation, etc.
- Other QA CMO duties as assigned.
- 1-5 years of directly related experience in a GMP Quality or Manufacturing environment.
- Working knowledge of process and desktop computers. Proven comprehension of technical information and regulatory expectations.
- The ideal candidate will have strong organization and communication skills.