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Responsibility:
- Carry out Microbiological testing and examination according to valid procedures; such as Biobuden, Endotoxin, Sterility, Growth Promotion, cell growth (cell culture)and Environmental Monitoring.
- Support to perform method validations for OEM, Bioscience and PreAnalytical products.
- Preparation of solutions and equipment for microbiology department according to valid Test Procedures (TPs) and Standard Operating Procedures (SOPs) as required.
- Review, edit, and draft of applicable TPs and SOPs.
- Review and maintain stock of consumables (supplies and equipment) for Microbiology department.
- Entry and trending of microbiological data for management review and trend evaluation.
- Validation testing for microbiological methods and sterilization validation as needed.
- Test non-conforming product to resolve QIR/NCR issues as well as investigate returned products via complaint processing system.
- Coordination of sample testing via external/third-party vendor(s).
- Issue QIR/NCR for non-conforming product and/or any lab test excursion and support to conduct root‑cause analysis as per standard procedure.
- Cleaning and sanitation of microbiology lab.
- Other duties as assigned.
Job Requirements:
- Minimum Bachelor’s Degree in a life science (preferably biology, microbiology, or related field).
- Minimum one (1) year of relevant work experience in GMP-controlled laboratory environment.
- Experience in Medical Device, Pharmaceutical, and/or regulated industry is preferred
- Must have sufficient math, communication, and writing skills.
- Must complete pre-employment examination and qualification test.
- Knowledge of basic Microbiology, and USP and/or FDA guidelines.
- Basic understanding of computer systems (Word, Excel, Outlook, and instrument dedicated).
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