Batch Record Reviewer
The Batch Record Reviewer is responsible for reviewing and releasing finished goods while ensuring all documentation meets Good Documentation Practices (GDP) and ALCOA+ data integrity principles.
- Review batch records and travelers for completeness, accuracy, and compliance.
- Release product in accordance with internal procedures and quality standards.
- Ensure all documentation adheres to GDP standards (legible, complete, properly corrected, and signed/date).
- Confirm data integrity in alignment with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).
- Ensure discrepancies, missing data, or documentation errors are identified and resolved prior to release.
- Develop deep understanding of company products including raw materials and components.
- Serve as a Subject Matter Expert (SME) for documentation requirements.
- Generate and issue Certificate of Conformance.
- Ensure certifications accurately reflect product specifications, test/inspection results, and applicable standards.
- Verify all supporting data is complete and approved prior to certification issuance.
- Able to maintain tight schedules for releases for different projects.
- Communicate effectively with Production, Engineering, and Quality teams regarding product status.
- Support Quality Control by performing inspections as needed to verify product conformance.
- Any other duties assigned by supervisor.