3rd Shift Quality Assurance Supervisor - (Allegan, MI)

The QA Supervisor reports to the Quality Assurance Manger and develops and maintains auditing methods which ensure identity control in raw materials, packaging, manufacturing and finished goods, with approval of final release of product for shipment. This position reviews and approves controlled documents, including SOPs, SWIs (Standard Work Instructions), Job Aids, SCRF (SAP Change Request Form), SBRF (Split Batch Request Form), RW's (Rework) Notifications, planned deviations and supplier advisories. Coordinates initial response activity including risk assessment and containment for Quality Events. Identifies any non conformances or variances, recommends corrective action, and ensures follow up actions are taken by working with staff and management in those areas. The incumbent Manages/trains non exempt staff to ensure that all documentation meets cGMP and FDA standards. Assists with FDA inspections as requested and ensures FDA readiness in Operations.