Quality Assurance Jobs | Siemens Healthineers Hiring Microbiologists | Apply Now
Looking for high-paying Quality Assurance Jobs in the pharmaceutical and healthcare industry? Siemens Healthineers is now offering exciting opportunities for candidates searching for Microbiology Jobs and Siemens Healthineers Careers in pharma QA and radiopharmaceutical manufacturing. This Quality Assurance Specialist role is perfect for those who want hands-on exposure to GMP compliance, CAPA systems, FDA audits, sterile manufacturing, and healthcare technology operations.
- Job Title: Quality Assurance Specialist
- Remote Type: Office Based
- Time Type: Full time
- Job Requisition ID: R-28177
About the Company
Siemens Healthineers is a global leader in healthcare technology operating in more than 70 countries with over 72,000 employees worldwide. The company specializes in medical imaging, diagnostics, cancer care, and advanced healthcare solutions. Its Radiopharma division supports innovative pharmaceutical manufacturing and quality systems that directly impact patient care and clinical outcomes worldwide.
Key Responsibilities
- 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 CAPAs, 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 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.
Education
Bachelor’s degree in a scientific field (i.e., biology, microbiology, etc.) is preferred or equivalent experience required.
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.
- 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.
- You have completed studies in Microbiology and/or Analytical Chemistry.
- Experience with MS Office software (Word, PowerPoint, Excel, and Outlook).
- Flexibility to travel.
Required Skills
- 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.
For candidates searching for Quality Assurance Jobs, Microbiology Jobs, and Siemens Healthineers Careers, this opportunity offers excellent exposure to pharmaceutical manufacturing, healthcare technology, GMP compliance, and regulatory quality systems. Working with a globally recognized healthcare company can significantly strengthen your career profile in pharma QA and life sciences.
