Microbiologist I

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.
  
  

We provide equal opportunities for everyone and see diversity as our strength. Therefore, we welcome all applicants – regardless of characteristics such as gender, age, background, social status, sexual orientation, religion, or mental and physical abilities. We have set the goal of empowering women and increasing female leader representation. We foster an inclusive work environment and encourage all individuals to apply.