QC Microbiologist I
American Regent, Inc. · Columbus, OH · 1 wk ago
AnalystFull-time
This position in the Microbiology Laboratory will be primarily responsible for performing, coordinating and tracking the microbiological testing for in-process and finished products as well as monitoring of controlled manufacturing facilities and utility systems.
Responsibilities
- Plan daily workload to meet requirements.
- 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 inside the sterile manufacturing areas.
- Conduct all water samplings throughout the manufacturing facility.
- Log, read, and record samples and data per cGMP and applicable compliance requirements.
- Perform calibration and performance verification of small laboratory instruments.
- Perform media preparation, glassware preparation, and operate autoclaves.
- Document findings and report discrepancies from standards.
- Communicate any discrepancies or deviations to management upon discovery.
- Conduct chart readings daily and change charts weekly.
- Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices, health, and safety requirements.
- Maintain and analyze data in the database and conduct trend analysis.
- Participate in identified projects.
- Perform any other tasks/duties as assigned by management.
Requirements
- 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.
- Strong ability to work independently and as a team.
- Ability to learn clean room technology and use of aseptic technique.
- Organized individual with strong attention to detail.
- Excellent communication skills (oral and written).
- Working knowledge of MS-Office software and PC skills.
- Good work ethic and highly motivated.
- 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.
- Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision.
- Must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
- Must be able to occasionally lift and/or move up to 25 pounds.