Quality Assurance Specialist

About the role

We are seeking a Quality Assurance Specialist to provide quality oversight for a US‑based site that manufactures and distributes radioactive sterile injectables (PET) in compliance with 21 CFR Part 212 and USP 825. The role supports GMP investigations, CAPA management, audits, and FDA inspections while driving continuous improvement.

Key responsibilities

• Provide quality oversight of manufacturing and distribution of PET radiopharmaceuticals, ensuring compliance with 21 CFR Part 212 and USP 825.
• Lead GMP investigations, CAPA implementation, change management, batch release, and batch record reviews.
• Conduct site quality audits, data‑integrity audits, and support internal and third‑party audits.
• Host and support FDA inspections and provide on‑site training/mentoring.
• Serve as subject‑matter expert on assigned topics, contributing to policies and procedures.
• Manage quality metrics, aiming to reduce batch record corrections, investigations, and failed batches.
• Perform internal form reviews, inventory management, staff qualification observations, and facility inspections.

Required profile

• 3‑5 years of QA experience in a 21 CFR Part 211/212 regulated environment, preferably sterile drug manufacturing or PET radiopharmaceuticals.
• Degree in microbiology, analytical chemistry or a related scientific field (or equivalent experience).
• Strong knowledge of regulatory policies (21 CFR Part 212, Part 11, USP 825) and ability to apply them.
• Expertise in root‑cause analysis, investigation writing, and CAPA management.
• Excellent attention to detail and ability to reprioritize in a fast‑paced environment.
• Willingness to travel 10‑25 % of the time.

Required skills

• MS Office (Word, PowerPoint, Excel, Outlook)
• GMP compliance
• CAPA processes
• Root‑cause analysis
• Investigation writing
• Regulatory compliance (21 CFR Part 212, Part 11, USP 825)
• Microbiology
• Analytical Chemistry

What we offer

• Opportunities for professional growth within a global healthcare leader.
• Supportive, diverse, and inclusive work environment.
• Resources and flexibility to develop both professionally and personally.