GMP QA Specialist - CAPA, Audits & Batch Release

Siemens Healthineers AG; 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

Disability insurance

Parking or public transit benefits

Paid time off

Paid sick time

Job summary

Siemens Healthineers is seeking a Quality Specialist to oversee quality at a US-based radiopharma site producing radioactive sterile injectables. You will focus on GMP investigations, CAPA, batch release, and audits, while supporting staff training and FDA inspections.

You will apply root-cause analysis, identify gaps, and drive continuous improvement in quality metrics, with travel as needed. Strong regulatory experience in 21 CFR Parts 211/212 and USP 825 is valued.

Qualifications

• Bachelor’s degree in a scientific field is preferred or equivalent experience.
• Experience in interpreting regulatory policies and guidance documents.
• Root cause analysis, investigation writing, and CAPA management.
• Identify procedural gaps and mitigate compliance risks.
• Travel 10% - 25%.

Responsibilities

• Provide quality oversight of a US-based site manufacturing radiopharmaceuticals under 21 CFR Part 212 and USP 825.
• Lead GMP investigations, CAPA, change control, batch release, and batch record reviews.
• Conduct internal and external quality audits and data integrity audits; support FDA inspections.
• Serve as SME on policies and procedures; contribute to decisions on critical topics.
• Engage in continuous improvement projects and improve quality metrics.

Skills

Attention to detail

Problem solving

Prioritization

Travel readiness

Quality mindset

Education

Bachelor’s degree in a scientific field

Studies in Microbiology or Analytical Chemistry

Tools

MS Office

Job description

Siemens Healthineers is seeking a Quality Specialist to oversee quality at a US-based radiopharma site producing radioactive sterile injectables. You will focus on GMP investigations, CAPA, batch release, and audits, while supporting staff training and FDA inspections.

You will apply root-cause analysis, identify gaps, and drive continuous improvement in quality metrics, with travel as needed. Strong regulatory experience in 21 CFR Parts 211/212 and USP 825 is valued.