Quality Assurance Specialist - Minneapolis, MN
About The Position
The Quality Assurance Specialist provides Quality oversight for a US-based Siemens Healthineers Radiopharma site that manufactures and distributes radioactive sterile injectables (PET) in accordance with 21 CFR Part 212 and USP 825. The role focuses on GMP investigations and CAPAs, change management, batch release and batch record reviews, site Quality audits, and data integrity audits. The position provides on-site support for training and mentoring, internal and third-party quality audits, and FDA inspections. The Specialist serves as a subject matter expert on assigned topics, contributing to related policies, procedures, and decisions, and participates in continuous improvement projects. The role also manages site quality metrics, including efforts to reduce batch record corrections, investigations, and failed batches due to operator error. Additional duties include internal form review, inventory management, observing staff qualifications, and facility inspection. Travel of 10%–25% is required.
Requirements
- Bachelor’s degree in a scientific field (such as biology, chemistry, microbiology, or pharmacy) preferred, or equivalent experience required.
- 3–5 years of relevant QA experience in a 21 CFR Part 211 or Part 212 regulated industry.
- Experience in the pharmaceutical industry, preferably sterile drug manufacturing, and/or PET radiopharmaceuticals under 21 CFR Part 212 and Part 11 and/or USP 825.
- Experience interpreting regulatory policies and guidance documents and applying them to relevant activities.
- Expertise in root cause analysis, investigation writing, and management of corrective and preventive actions.
- Ability to identify procedural gaps and product risk and, where appropriate, recommend contingency plans and strategies to mitigate compliance risks.
- Studies completed in Microbiology and/or Analytical Chemistry.
- Experience with MS Office software, including Word, PowerPoint, Excel, and Outlook.
- Excellent attention to detail.
- Creative problem-solving skills and ability to reprioritize multiple times per day while delivering results on time.
- Willingness to travel 10%–25%.
- Flexibility to travel.
Nice To Haves
- Bachelor’s degree in a scientific field is preferred.
- Experience in sterile drug manufacturing is preferred.
Responsibilities
- Provide Quality oversight for a US-based site manufacturing and distributing radioactive sterile injectables (PET) under 21 CFR Part 212 and USP 825.
- Focus on GMP investigations and CAPAs, change management, batch release, and batch record reviews.
- Perform site Quality audits and data integrity audits.
- Provide on-site training and mentoring support.
- Perform internal and third-party quality audits and host or support FDA inspections.
- Serve as a subject matter expert on assigned topics and provide input on related policies, procedures, and decisions.
- Participate in continuous improvement projects.
- Manage site quality metrics, including efforts to reduce batch record corrections, investigations, and failed batches due to operator error.
- Review internal forms, manage inventory, observe staff qualifications, and inspect the facility.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) retirement plan
- Life insurance
- Long-term and short-term disability insurance
- Paid parking/public transportation
- Paid time off
- Paid sick and safe time
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
