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Quality Assurance Specialist
2 months ago
The Quality Inspector plays a crucial role in ensuring the quality of our products by monitoring manufacturing and filling/packaging activities, coordinating training as needed, and supporting challenges on the production floor.
Key Responsibilities- Verify line clearance of packaging/filling line equipment before production runs
- Monitor environmental conditions in GMP areas
- Issue labeling material
- Ensure packaging/filling lines have correct documentation, packaging components, and product before and during packaging runs
- Complete packaging pages accurately
- Perform in-process fill checks throughout packaging runs in accordance with SOP and packaging pages
- Collect retain and laboratory evaluation samples as per SOP or packaging page
- Conduct finished product counts, including date, number of pallets, number of cases, and perform calculations to document accurate counts
- Back-flush product as pallets complete, utilizing the BEAS system interface to SAP
- Print and verify accuracy of pallet count sheets, attaching them to pallets
- Ensure completeness of label reconciliation sheets and return unused labels to the label room
- Verify equipment logbooks have been completed and accurately filled out by quality and production associates at the beginning and end of packaging runs
- Report quality non-conformances and deviations to the quality lead and management
- Ensure all documentation is reported using cGMP/good documentation practices and applicable SOP, as well as industry best practices
- Perform other duties as assigned by management
- Preferred high school diploma or equivalent
- Read, write, and comprehend SOP, master batch records, test procedures, and other relevant technical documents in English
- Perform calculations
- High level of attention to detail