Role Overview:
The QA Specialist will establish and oversee quality processes at a state-of-the-art radiopharmaceutical production facility. WILL ROTATE BETWEEN 1st AND 2nd SHIFT ON A MONTHLY BASIS
Key Responsibilities
- Develop/review QA documents and oversee equipment qualification.
- Lead batch release and ensure compliance with GMP standards.
- Conduct inspections, manage CAPAs, and resolve deviations.
- Promote a culture of quality and mentor QA team members.
Qualifications
Required:
- 3+ years QA experience (2+ in pharma, 1+ in aseptic manufacturing).
- GMP knowledge and cleanroom expertise.
- Strong problem-solving, organizational, and leadership skills.
Preferred:
- BA/BS in a scientific field and radiopharmaceutical experience.
- FDA inspection and facility start-up knowledge.
