Quality Assurance Specialist, PET Radiopharma (On‑Site)

Siemens Healthineers AG; United States; On-site; USD 101,000 - 139,000; 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 is seeking a Quality Specialist to oversee a US-based site manufacturing radioactive sterile injectables (PET), ensuring compliance with 21 CFR Part 212 and USP 825. You will drive GMP investigations, CAPAs, batch release and record reviews, and site audits.

You will also train staff, conduct internal and third-party audits, support FDA inspections, and contribute to continuous improvement through quality metrics management.

Qualifications

• Bachelor’s degree in a scientific field or equivalent experience required.
• Excellent attention to detail and meticulous work.
• Creative problem solving and ability to reprioritize daily.
• Willing to travel 10–25% to support site activities.
• 3–5 years of QA experience in a 21 CFR Part 211 or 212 regulated industry.

Responsibilities

• ProvideQuality oversight of a US-based site manufacturing and distributing radioactive sterile injectables per 21 CFR Part 212 and USP 825.
• Focus on GMP investigations and CAPAs, change management, batch release and batch record reviews.
• Conduct site quality audits and data integrity audits to support Radiopharma’s oversight functions.
• Provide on-site training/mentoring, perform internal and third-party quality audits, and support FDA inspections.

Skills

Attention to detail

Creative problem solving

Prioritization under pressure

Travel willingness (10-25%)

Education

Bachelor’s degree in a scientific field

Microbiology studies

Analytical Chemistry studies

Job description

Siemens Healthineers is seeking a Quality Specialist to oversee a US-based site manufacturing radioactive sterile injectables (PET), ensuring compliance with 21 CFR Part 212 and USP 825. You will drive GMP investigations, CAPAs, batch release and record reviews, and site audits.

You will also train staff, conduct internal and third-party audits, support FDA inspections, and contribute to continuous improvement through quality metrics management.