Quality Assurance Specialist

Join to apply for the Quality Assurance Specialist role at Siemens Healthineers
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Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

• Providing Quality oversight of a US based site that manufactures and distributes radioactive sterile injectables (PET) per 21 CFR Part 212 and USP 825 for PETNET Solutions.
• Focusing on GMP Investigations and CAPA’s, change management, batch release and batch record reviews, site Quality audits and data integrity audits to support PETNET’s Quality oversight functions.
• Provide on-site support for training/mentoring, performing internal and third‑party quality audits and hosting/supporting 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, 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, observation of staff qualifications and facility inspection.

• 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 correctly applying them to related activities.
• Expertise 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 issues.
• 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 (biology, chemistry, microbiology, pharmacy, etc.) is preferred or equivalent experience is 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.
• Willingness to travel 10% – 25%.
• Relevant QA experience 3‑5 years in a 21 CFR Part 211 or 212 regulated industry.

Min $102,600 – Max $153,900

Factors that may affect starting pay within this range include geography/market, skills, education, experience, and other qualifications of the successful candidate.

If this is a commission eligible position, commission eligibility will be in accordance with the Company’s plan. Commissions are based on individual performance and/or company performance.

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.

Siemens Healthineers is an Equal Opportunity and affirmative‑action employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender status, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

Applicants and employees are protected under federal law from discrimination. To learn more, .

Siemens Healthineers is committed to providing reasonable accommodations to persons with disabilities as part of its equal employment opportunity commitment.