QA Compliance Specialist Job - (Waunakee, WI)

The QTI Group is partnering with a Madison-area client to recruit for a QA Compliance Specialist . Reporting to the QA Manager, this individual will develop and oversee the execution of written procedures designed to ensure current Good Manufacturing Practice (cGMP) compliance in such areas as record review and retention; sampling and evaluating incoming raw materials; sampling and evaluating facility water, air, and other specified utility systems. We will consider entry-level up to senior-level for this role. Assignments include: Oversee and coordinate investigations, provide direction and guidance for investigations and execute them as needed Develop and oversee execution of contract and protocol-based manufacturing, including support for the release of pharmaceutical product and coordinating documentation for shipments. Review completed batch manufacturing records to ensure completeness and compliance with process parameters prior to product release.