QC Microbiologist I

American Regent, Inc.•Columbus, OH

About The Position

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. Essential Duties and Responsibilities Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. 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. Conducts all water samplings throughout manufacturing facility. Logging, reading and recording samples and data per cGMP and applicable compliance requirements. Calibration, performance verification of small laboratory instruments. Perform media preparation, glassware preparation and operate autoclaves. Documents findings and report discrepancies from standards. Communicate any discrepancies or deviations to management upon discovery. Conducts chart readings daily and changing chart 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 analyzes data in database and conduct trend analysis.

Requirements

Bachelor’s degree in Microbiology, Biology, or equivalent Life Science curriculum required.
One year experience in the pharmaceutical industry, food industry, Cosmetics, medical devices, Laboratory Pathology preferred.
Ability to learn clean room technology and use of aseptic technique.
Organized individual with strong attention to detail.
Working knowledge of MS-Office software and PC Skills Required.
Ability to work overtime as needed.
Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves.
PPE and Respirators are essential for the health and safety of employees.
Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision.
Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.

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.
Conducts all water samplings throughout manufacturing facility.
Logging, reading and recording samples and data per cGMP and applicable compliance requirements.
Calibration, performance verification of small laboratory instruments.
Perform media preparation, glassware preparation and operate autoclaves.
Documents findings and report discrepancies from standards.
Communicate any discrepancies or deviations to management upon discovery.
Conducts chart readings daily and changing chart 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 analyzes data in database and conduct trend analysis.