Quality Assurance Specialist
Siemens Healthineers
Summary
As a Corporate Quality Specialist, you will provide Quality oversight of the Production Support Lab, the Technical Support Team and Implementation Team, supporting US based sites that manufacture and distribute radioactive sterile injectables (PET) per 21 CFR Part 212 and USP 825 for Radiopharma.
Job description
- Act as the Quality System Officer (QSO) for the listed corporate teams.
- Assist the Corporate Quality group with root cause analysis and trend analysis of technical issues to support GMP investigations and CAPAs.
- Review GMP-related investigations, CAPAs, change controls, etc. to ensure technical components are accurate.
- Serve as subject matter expert on assigned topics providing input on policies, procedures and decisions.
- Participate in continuous improvement and trend analysis projects.
- Review qualifications and other documentation.
- Provide GMP training to corporate personnel as needed.
- Support audits and inspections as needed to support Radiopharma's Quality oversight functions.
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.
- At least 3 years of experience manufacturing radiopharmaceuticals and at least 3 years of experience performing QC testing of radiopharmaceuticals.
- Experienced in quality assurance disciplines of problem-solving, 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.
- Ability to coordinate between different departments to ensure tasks are on track and compliance is maintained.
- Completed studies in Microbiology and/or Analytical Chemistry or a similar technical discipline.
- Ability to proactively manage schedule to ensure all assigned responsibilities are completed accurately and on schedule.
- Good PC skills (MS Office software like Word, PowerPoint, Excel and Outlook).
- Willingness to travel and be flexible.
Required Skills
- Bachelor's degree in a scientific field (i.e., biology, chemistry, microbiology, pharmacy, etc.) is preferred or equivalent experience required.
- Excellent attention to detail.
- Ability to manage own schedule efficiently to ensure all job responsibilities are completed on-time and with a high degree of excellence.
- 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%.
Requirements
- 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
- At least 3 years of experience manufacturing radiopharmaceuticals
- At least 3 years of experience performing QC testing of radiopharmaceuticals
- Experienced in quality assurance disciplines of problem-solving, 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
- Ability to coordinate between different departments to ensure tasks are on track and compliance is maintained
- Completed studies in Microbiology and/or Analytical Chemistry or a similar technical discipline
- Ability to proactively manage schedule to ensure all assigned responsibilities are completed accurately and on schedule
- Good PC skills (MS Office software like Word, PowerPoint, Excel and Outlook)
- Willingness to travel and be flexible
- Bachelor's degree in a scientific field (i.e., biology, chemistry, microbiology, pharmacy, etc.) is preferred or equivalent experience required
- Excellent attention to detail
- Ability to manage own schedule efficiently to ensure all job responsibilities are completed on-time and with a high degree of excellence
- 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%
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.