Radiopharma QA Specialist: GMP, CAPA & Audits

Siemens Healthineers AG; Loma Linda (CA); 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

long-term and short-term disability

Job summary

Siemens Healthineers is seeking a Quality Specialist to provide quality oversight at a US-based site manufacturing radioactive sterile injectables (PET) in compliance with 21 CFR Part 212 and USP 825. You will lead GMP investigations, CAPAs, batch release reviews, and site audits, while mentoring staff and supporting FDA inspections.

The role requires 3–5 years QA experience in regulated environments, strong analytical skills, and travel up to 25%.

Qualifications

• 3-5 years of QA experience in a 21 CFR Part 211 or 212 regulated industry.
• Experience interpreting regulatory policies and applying them to activities.
• Expertise in problem-solving, root cause analysis, investigation writing, and CAPA management.
• Identify procedural gaps and assess product risk with contingency planning.
• Travel availability up to 25%.

Responsibilities

• Provide quality oversight for a US-based site manufacturing/packing radioactive sterile injectables (PET) per 21 CFR Part 212 and USP 825.
• Lead GMP investigations, CAPAs, batch release and batch record reviews, site quality audits and data integrity audits.
• Provide on-site support for training/mentoring, internal and 3rd party audits, and FDA inspections.
• Serve as SME on topics related to quality policies and procedures.
• Participate in continuous improvement projects and manage site quality metrics.

Skills

QA experience

Regulatory interpretation

Root cause analysis

Problem solving

Education

Bachelor’s degree in a scientific field

Tools

MS Office

Job description

Siemens Healthineers is seeking a Quality Specialist to provide quality oversight at a US-based site manufacturing radioactive sterile injectables (PET) in compliance with 21 CFR Part 212 and USP 825. You will lead GMP investigations, CAPAs, batch release reviews, and site audits, while mentoring staff and supporting FDA inspections.

The role requires 3–5 years QA experience in regulated environments, strong analytical skills, and travel up to 25%.