QC Microbiologist I
3 days ago
This position in the Microbiology Laboratory will be primarily responsible for performing, coordinating and tracking microbiological testing for in-process and finished products, as well as monitoring controlled manufacturing facilities and utility systems.
Key Responsibilities
• Plan daily workload to meet requirements and ensure timely completion of tasks.
• Conduct microbiological testing, including Gram stain, microbial identification, LAL, environmental monitoring, growth promotion, microbial limits, and water testing.
• Conduct environmental monitoring activities, including air, surface, and personnel sampling inside sterile manufacturing areas.
• Perform water sampling throughout the manufacturing facility and log, read, and record samples and data according to cGMP and applicable compliance requirements.
• Calibrate and perform performance verification of small laboratory instruments, prepare media and glassware, and operate autoclaves.
• Document findings and report discrepancies from standards, communicating any issues to management upon discovery.
• Conduct chart readings daily and change charts weekly, ensuring all work is performed and documented in accordance with company policies, procedures, Current Good Manufacturing Practices, and health and safety requirements.
• Maintain and analyze data in a database, conducting trend analysis as needed.
Requirements and Qualifications
• Bachelor's degree in Microbiology, Biology, or equivalent Life Science curriculum required.
• One year of experience in the pharmaceutical industry, food industry, cosmetics, medical devices, or Laboratory Pathology preferred.
• Ability to learn clean room technology and use aseptic technique, with strong attention to detail and organizational skills.
• Working knowledge of MS-Office software and PC skills required, with ability to work overtime as needed.
Physical Environment and Requirements
• Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves, with specific vision requirements including 20/40 near vision (correctable with eyeglasses or contacts) and color vision.
• Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
American Regent celebrates diversity and is committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
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