Quality Assurance Specialist – Radiopharma GMP & CAPA

Regulatory Jobs; Cincinnati (OH); On-site; USD 89,000 - 123,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Paid parking/public transportation

Paid time off

Paid sick and safe time

Job summary

Siemens Healthineers in Cincinnati is seeking a Quality Specialist to oversee a US-based PET radiopharmaceutical site. You will lead GMP investigations, CAPAs, batch record reviews, and site quality audits, ensuring compliance with 21 CFR Part 212 and USP 825.

On-site training and audits, plus travel to support inspections, are part of the role. Ideal candidates have 3–5 years of QA experience in a regulated environment, strong problem-solving skills, and the ability to interpret regulatory

Qualifications

• Bachelor’s degree in a scientific field preferred or equivalent experience.
• Excellent attention to detail and proactive problem solving.
• Experience interpreting regulatory policies and guidance documents.

Responsibilities

• Provide quality oversight for a US-based site manufacturing and distributing radioactive sterile injectables (PET) per 21 CFR Part 212 and USP 825.
• Lead GMP investigations and CAPAs, change management, batch release, and batch record reviews.
• Support on-site training, mentoring, and host FDA inspections; perform internal and third-party quality audits.

Job description

Siemens Healthineers in Cincinnati is seeking a Quality Specialist to oversee a US-based PET radiopharmaceutical site. You will lead GMP investigations, CAPAs, batch record reviews, and site quality audits, ensuring compliance with 21 CFR Part 212 and USP 825.

On-site training and audits, plus travel to support inspections, are part of the role. Ideal candidates have 3–5 years of QA experience in a regulated environment, strong problem-solving skills, and the ability to interpret regulatory