Quality Assurance Specialist

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 Siemens Healthineers Radiopharma.
• Focusing 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 the purposes of training/mentoring, performing internal and 3rd party quality audits and hosting/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.

• 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.
• Are an 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.
• You have 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.
• Be a 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.

Base pay range: $89,220 - $122,672.

The Company offers 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.

Equal Employment Opportunity Statement: 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 their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, trans­gender, 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.

EEO is the Law:
Applicants and employees are protected under Federal law from discrimination. To learn more, .

Reasonable Accommodations:
Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations.

If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing,…