Radiopharma QA Specialist - GMP, CAPA & Audits

Regulatory Jobs; Minneapolis (MN); On-site; USD 92,000 - 126,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Long-term disability

Short-term disability

Paid parking/public transportation

Paid time off

Paid sick time

Job summary

Siemens Healthineers seeks a Quality Specialist to provide quality oversight for a US-based site manufacturing radioactive sterile injectables (PET) under 21 CFR Part 212 and USP 825. You will lead GMP investigations, CAPAs, batch release reviews, site audits and data integrity audits to support radiopharma quality oversight.

Travel 10–25% is required. A scientific degree and 3–5 years QA experience in a regulated environment are preferred, with strong problem-solving skills and MS Office

Qualifications

• Bachelor's degree in a scientific field preferred or equivalent experience.
• Excellent attention to detail and analytical thinking.
• Creative problem solver with ability to reprioritize quickly.
• Willing to travel 10%–25%.
• 3–5 years QA experience in a 21 CFR Part 211/212 regulated industry.

Responsibilities

• Provide Quality oversight of a US site manufacturing and distributing radioactive sterile injectables (PET) per 21 CFR Part 212 and USP 825.
• Focus on GMP investigations and CAPAs, change management, batch release and batch record reviews.
• Support site quality audits and data integrity audits for Radiopharma quality oversight.
• Host/support FDA inspections and on-site training/mentoring.
• Act as SME on assigned topics and participate in continuous improvement projects.
• Manage quality metrics, including batch record corrections and investigated failures.

Skills

QA experience 3-5 years in 21 CFR Part

Attention to detail

Creative problem solving

Willing to travel 10-25%

Bachelor's degree in scientific field

Education

Bachelor's degree in science

Tools

MS Office

Job description

Siemens Healthineers seeks a Quality Specialist to provide quality oversight for a US-based site manufacturing radioactive sterile injectables (PET) under 21 CFR Part 212 and USP 825. You will lead GMP investigations, CAPAs, batch release reviews, site audits and data integrity audits to support radiopharma quality oversight.

Travel 10–25% is required. A scientific degree and 3–5 years QA experience in a regulated environment are preferred, with strong problem-solving skills and MS Office