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).

Physical Requirements:

• Must be able to stand and walk for up to 8 hours.
• Must be able to lift up to 70 lbs.
• Must have appropriate vision to perform detailed quality inspection as outlined in SOPs and TPs.