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Quality Control Microbiologist
Job in
Boca Raton, Palm Beach County, Florida, 33481, USA
Listed on 2026-02-16
Listing for:
Intellectt Inc
Full Time
position Listed on 2026-02-16
Job specializations:
-
Healthcare
Medical Science -
Quality Assurance - QA/QC
Job Description & How to Apply Below
We are seeking an experienced QC Microbiology Specialist to join our team in a sterile manufacturing environment. The ideal candidate will have a strong background in microbiological testing of injectable products and a thorough understanding of cGMP regulations. This role involves performing and overseeing microbiology testing, ensuring data integrity, supporting investigations, and maintaining audit readiness.
ExperienceRequired:
- Minimum 10 years of experience in Quality Control Microbiology
- Hands-on experience with injectable (sterile) products is mandatory
- Perform and oversee sterility testing for injectable products
- Conduct comprehensive microbiology laboratory testing, including:
- Endotoxin (LAL) testing
- Growth promotion testing
- Ensure compliance with cGMP regulations and relevant regulatory guidelines
- Maintain accurate laboratory documentation and uphold data integrity
- Review, interpret, and approve microbiology test results
- Support investigations related to OOS (Out of Specification) / OOT (Out of Trend) microbiological results
- Participate in audit readiness activities and regulatory inspections
- Extensive hands-on experience in a sterile manufacturing microbiology laboratory
- Deep understanding of aseptic techniques and testing requirements for injectable products
- Knowledge of FDA regulations and GMP requirements
- Strong documentation, analytical, and investigative skills
- Detail-oriented with a commitment to quality and compliance
Skills:
- Experience with regulatory audits and inspection support
- Strong problem-solving and troubleshooting abilities
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