Batch Record Reviewer

16 hours ago


Andover, Massachusetts, United States Master Compliance Full time
Key Responsibilities
  • Collaborate as an active member of the Quality Assurance Operations Team and work closely with technical and analytical teams to maintain high standards of compliance and quality assurance.
  • Provide support during CMO batch production for Manufacturing and Testing Operations, ensuring timely and compliant handling of unexpected events.
  • Review and approve critical documents, including CMO manufacturing batch records, lot disposition documentation, Certificates of Analysis, deviations, investigations, and OOS records to support product release.
  • Perform data entry for lot release cycle times to generate metrics.


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