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Quality Specialist
Ref No.: 17-15914
Location: Ridgefield, New Jersey
Review manufacturing formulation batch production records to ensure compliance with internal specifications and cGMP regulations.
Compile history records for medical lots in preparation for product release.
Review specifications and SOP’s.
Monitor and trend batch record errors.
Provide quarterly/yearly Metrics to Quality Assurance management with quality indicator data.
Review analytical and microbiology specifications/testings.
Reviews, approves and tracks closure of deviations, non-conformances, OOS and corrective actions
Performs batch record closure and product disposition
Maintained non-conformances/root causes using the Track-Wise system

SAP, Trackwise, Microsoft office and StarLIMs.