Quality Assurance Specialist

The Quality Assurance Specialist provides oversight for a US-based site manufacturing and distributing radioactive sterile injectables, ensuring compliance with 21 CFR Part 212 and USP 825. The role involves managing GMP investigations, CAPAs, batch release, and quality audits while supporting FDA inspections and continuous improvement initiatives. This position requires expertise in quality assurance disciplines, regulatory compliance, and data integrity within the pharmaceutical or radiopharmaceutical industry.