Microbiology QA Job at Siemens Healthineers | Biology Graduates Apply Now
Siemens Healthineers is seeking a Quality Assurance Specialist in Columbia, South Carolina. This full-time role provides the opportunity to oversee quality operations for PETNET Solutions, supporting sterile injectable manufacturing and ensuring regulatory compliance. If you are passionate about driving healthcare innovation while advancing your career, this opportunity is designed for you.
- Job Position: Quality Assurance Specialist
- Location: Columbia, South Carolina, United States of America
- Category: Engineering
- Job Type: Full-time, Regular
- Job ID: R-23945
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Salary Range: $78,000 โ $117,000 annually (based on skills, experience, and qualifications)
About the Company
Siemens Healthineers is a global leader in medical technology, with over 73,000 dedicated professionals across more than 70 countries. The company pioneers breakthroughs in healthcare through diagnostics, imaging, and advanced therapies, enabling better outcomes and sustainable access to care. At Siemens Healthineers, employees are empowered to innovate, collaborate, and grow in a diverse and inclusive environment.
QA Job Description
As a Quality Assurance Specialist, you will provide quality oversight at a U.S.-based PETNET Solutions site that manufactures and distributes radioactive sterile injectables. You will focus on GMP investigations, CAPAs, audits, and compliance activities to ensure regulatory excellence. This role requires expertise in quality systems, problem-solving, and regulatory compliance, as outlined in 21 CFR Part 212 and USP 825.
Key Responsibilities
- Provide quality oversight of sterile injectable manufacturing operations.
- Lead GMP investigations, corrective and preventive actions (CAPAs), and change management.
- Conduct batch release reviews, batch record audits, and site quality audits.
- Serve as subject matter expert (SME) on assigned quality topics.
- Provide on-site training, mentoring, and audit hosting for FDA inspections.
- Support continuous improvement initiatives and manage site quality metrics.
- Review internal forms, manage inventory, and perform facility inspections.
QA Job – Educational Qualifications
Bachelorโs degree in a scientific field (biology, microbiology, pharmacy, etc.) preferred, or equivalent experience.
Experience and Skills
- 3โ5 years of relevant QA experience in a 21 CFR Part 211 or 212 regulated industry.
- Experience in sterile drug manufacturing and/or PET radiopharmaceuticals preferred.
- Strong background in root cause analysis, investigation writing, and CAPA management.
- Familiarity with regulatory guidelines (21 CFR Part 11, Part 212, USP 825).
- Excellent attention to detail, communication, and problem-solving skills.
- Proficiency with MS Office (Word, Excel, PowerPoint, Outlook).
- Flexibility to travel 10% โ 25%.
Compensation and Benefits
- Salary: $78,000 โ $117,000 annually.
- Benefits: Medical, dental, vision insurance; 401(k) retirement plan; life insurance; short- and long-term disability; paid time off; sick and safe time; and paid parking/public transportation support.
Keywords: Siemens Healthineers, Quality Assurance Specialist, Engineering, South Carolina, Pharmaceutical, Microbiology, Analytical Chemistry, Microbiology QA Job at Siemens Healthineers | Biology Graduates Apply Now
