Quality Assurance Specialist

The Quality Assurance Specialist provides oversight for a US-based site manufacturing radioactive sterile injectables, ensuring compliance with 21 CFR Part 212 and USP 825 regulations. The role involves managing GMP investigations, CAPAs, batch releases, and quality audits while serving as a subject matter expert to support FDA inspections and continuous improvement initiatives. This position requires a scientific background and experience in pharmaceutical quality assurance to maintain high standards of data integrity and operational excellence.