Contract
Actalent
St. Louis, MO, USA
Job Description The primary role of the QA Engineer is to develop and monitor quality management systems and processes to ensure compliance with FDA regulations. The position is responsible for maintaining Process Variance Reports and Annual Product Reviews for the manufacturing and distribution locations, ensuring that budget and schedule remain compliant with contract and department needs. Responsibilities Ensure GMP required documentation complies with governmental regulations such as FDA. Monitor and interpret the Federal Register and other sources for laws related to Food, Drugs, and Cosmetic Industries. Define and improve systems and processes. Maintain the quality system of Process Variance Reports (PVR). Generate Annual Product Reviews (APR). Conduct customer complaint investigations. Maintain quality attributes in customer specification portals. Develop or assist with process control procedures and automation specifications to ensure ongoing compliance....


