Quality Assurance Specialist - Minneapolis, MN
Siemens Healthineers
Summary
As a Quality Specialist, you will provide Quality oversight of a US based site that manufactures and distributes radioactive sterile injectables (PET) per 21 CFR Part 212 and USP 825 for Siemens Healthineers - Radiopharma.
Job description
Responsibilities
- Focus on GMP Investigations and CAPA's, change management, batch release and batch record reviews, site Quality audits and data integrity audits to support Radiopharma's Quality oversight functions.
- Provide on-site support for training/mentoring, performing internal and 3rd party quality audits and to host/support FDA inspections.
- Serve as the subject matter expert on assigned topics providing input on policies, procedures and decisions related to those topics.
- Participate in continuous improvement projects.
- Manage quality metrics at the site, including focusing on reduction of batch record corrections, investigations, failed batches due to operator error and other quality metrics as assigned.
- Additional responsibilities include internal form review, inventory management, observations of staff qualifications and facility inspection.
Qualifications
- Experience in the pharmaceutical industry (preferably sterile drug manufacturing) and/or PET radiopharmaceuticals per 21 CFR Part 212 and Part 11 and/or USP 825.
- Experience in interpreting regulatory policies and guidance documents and can correctly apply them as appropriate to related activities.
- Expert in the quality assurance disciplines of problem-solving root cause analysis, investigation writing, and management of corrective and preventive actions.
- Identify procedural gaps and product risk and where appropriate, recommend contingency plans and strategies to mitigate compliance.
- Completed studies in Microbiology and/or Analytical Chemistry.
- Experience with MS Office software (Word, PowerPoint, Excel and Outlook).
- Flexibility to travel.
- Bachelor's degree in a scientific field (i.e., biology, chemistry, microbiology, pharmacy, etc.) is preferred or equivalent experience required.
- Excellent attention to detail.
- Creative problem solver with the ability to reprioritize multiple times per day while working at the speed of business and delivering results on time.
- Willing to travel 10% - 25%.
- Relevant QA experience for 3-5 years in a 21 CFR Part 211 or 212 regulated industry.
Requirements
- Bachelor's degree in a scientific field (i.e., biology, chemistry, microbiology, pharmacy, etc.) is preferred or equivalent experience required
- Relevant QA experience for 3-5 years in a 21 CFR Part 211 or 212 regulated industry
- Experience in the pharmaceutical industry (preferably sterile drug manufacturing) and/or PET radiopharmaceuticals per 21 CFR Part 212 and Part 11 and/or USP 825
- Experience in interpreting regulatory policies and guidance documents
- Expert in quality assurance disciplines of problem-solving root cause analysis, investigation writing, and management of corrective and preventive actions
- Completed studies in Microbiology and/or Analytical Chemistry
- Experience with MS Office software (Word, PowerPoint, Excel and Outlook)
- Willing to travel 10% - 25%
- Excellent attention to detail
- Creative problem solver with ability to reprioritize multiple times per day
Benefits
- Medical Insurance
- Dental Insurance
- Vision Insurance
- 401(k) Retirement Plan
- Life Insurance
- Long-term Disability Insurance
- Short-term Disability Insurance
- Paid Parking
- Public Transportation
- Paid Time Off
- Paid Sick and Safe Time
Company overview
Siemens Healthineers is a German multinational medical technology company specializing in diagnostic and therapeutic imaging, laboratory diagnostics, and molecular medicine. Founded in 2017 as a spin-off from Siemens AG, the company has established itself as a global leader in healthcare technology with a comprehensive portfolio that addresses the complete care continuum for many of the world's most threatening diseases. With approximately 69,500 employees worldwide and operations in over 70 countries, Siemens Healthineers generates annual revenues exceeding €21 billion. The company's product offerings span across four main business segments: Imaging (including CT, MRI, ultrasound, and X-ray systems), Diagnostics (laboratory and point-of-care testing), Varian (cancer care and radiation therapy), and Advanced Therapies. Siemens Healthineers is particularly renowned for pioneering breakthroughs in medical imaging, having developed the world's first commercial PET/CT scanner and continuing to innovate in areas such as artificial intelligence, digital health solutions, and precision therapy. The company's commitment to research and development, with annual investments of approximately €1.5 billion, drives its mission to pioneer breakthroughs in healthcare for everyone, everywhere, sustainably.