Quality Assurance Specialist
About The Position
The Quality Assurance Specialist provides Quality oversight for a U.S.-based site that manufactures and distributes radioactive sterile injectables (PET) for Siemens Healthineers Radiopharma under 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, conducting internal and third-party quality audits, and hosting or supporting 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, with an emphasis on reducing batch-record corrections, investigations, operator-error-related failed batches, and other assigned metrics. Additional duties include internal form review, inventory management, observing staff qualifications, and facility inspection. Travel of 10%–25% is expected.
Requirements
- Relevant QA experience of 3–5 years in a 21 CFR Part 211 or Part 212 regulated industry.
- Bachelor’s degree in a scientific field (such as biology, chemistry, microbiology, or pharmacy) preferred, or equivalent experience required.
- Excellent attention to detail.
- Ability to creatively solve problems, reprioritize multiple times per day, work at the speed of business, and deliver results on time.
- Willingness to travel 10%–25%.
- 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 appropriately.
- Expertise in root-cause analysis, investigation writing, and management of corrective and preventive actions.
- Ability to identify procedural gaps and product risk and recommend contingency plans and strategies to mitigate compliance risks.
- Completed studies in Microbiology and/or Analytical Chemistry.
- Experience with MS Office software, including Word, PowerPoint, Excel, and Outlook.
Nice To Haves
- Experience in the pharmaceutical industry, preferably sterile drug manufacturing.
- Experience with PET radiopharmaceuticals under 21 CFR Part 212 and Part 11 and/or USP 825.
- Bachelor’s degree in a scientific field is preferred.
Responsibilities
- Provide Quality oversight of a U.S.-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.
- Conduct 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
