About This Role
This role supports the Quality Control Microbiology Laboratory by performing microbiological testing, environmental monitoring, data review, and quality system activities. The Microbiologist ensures compliance with GMP, GLP, regulatory, and company requirements, and is responsible for timely testing and release support for raw materials, finished products, water systems, and packaging materials.
Responsibilities
- Perform microbiological analysis of raw materials, finished products, water samples, and packaging materials in accordance with approved procedures and specifications
- Execute environmental monitoring activities for manufacturing areas and microbiology laboratories, including trend analysis and reporting
- Prepare microbiological media and perform Growth Promotion Testing (GPT) to support laboratory testing activities
- Review, interpret, and document microbiological test results while ensuring data integrity and compliance with GMP/GLP requirements
- Support laboratory investigations including deviations, OOS/OOT events, change controls, CAPAs, and annual product quality reviews
- Conduct microbial identification activities and support investigation of environmental and product-related microbiological excursions
- Participate in qualification, validation, calibration, and routine verification of microbiology laboratory equipment, methods, AHUs, and LAF systems
Requirements
- Bachelor's or Master's degree in Microbiology, Biotechnology, Life Sciences, Pharmaceutical Sciences, or a related scientific discipline
- Experience in a Quality Control Microbiology laboratory within the pharmaceutical, healthcare, life sciences, or regulated manufacturing industry
- Strong knowledge of microbiological testing techniques, environmental monitoring, water testing, microbial identification, and aseptic laboratory practices
- Understanding of GMP, GLP, data integrity requirements, and applicable regulatory guidelines
- Experience handling laboratory quality systems including deviations, CAPAs, change controls, OOS/OOT investigations, and audit support
- Familiarity with qualification, validation, calibration, and maintenance of microbiology laboratory equipment and systems
- Strong analytical, problem-solving, documentation, and data review capabilities
Benefits
- Opportunity to contribute to the production of high-quality healthcare products through robust microbiological quality control practices
- Hands-on experience with microbiological testing, environmental monitoring, microbial identification, and laboratory investigations
- Exposure to GMP-compliant quality systems including deviations, OOS/OOT investigations, change controls, CAPAs, and audits
