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Quality Operations Specialist - 1st Shift
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$35 an hour
- The QA Associate is responsible for the Quality support functions associated with the manufacturing.
- The essential responsibilities associated with this position are oversight of the manufacturing operations (as dictated by cGMP, CFR, and Catalent SOP) through document review/approval and real time monitoring/approval of manufacturing activities.
- Real-time audit of batch records in the production for completeness, documentation, calculation errors and conformance to critical process parameters
- Maintain a full understanding of all Catalent SOPs and policies along with all cGMP and CFR guidance that are applicable to manufacturing.
- Monitor production manufacturing areas for compliance to SOP/cGMP/batch record and safety requirements in order to identify and resolve routine errors and prevent possible deviations that affect production real-time.
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