QC Microbiologist II

American Regent, Inc. • Columbus, OH

2d

About The Position

The QC Microbiologist II works in the Microbiology Laboratory and is primarily responsible for specialized routine testing, including bacterial endotoxin testing; validation and routine testing of raw material, in-process, and antimicrobial effectiveness testing samples; and support for event report drafting. The role also performs routine laboratory work, maintains and analyzes data, supports validation and special studies, and assists with investigations and training. Work must be completed and documented in accordance with company policies and procedures, current Good Manufacturing Practices, and health and safety requirements.

Requirements

• Bachelor’s degree in microbiology, biology, or an equivalent life science curriculum.
• A minimum of 2–5 years of experience working in a cGMP-compliant microbiology laboratory, such as in the pharmaceutical, food, cosmetics, medical device, or pathology laboratory industry.
• Working knowledge of biological indicators for steam, VHP, and ETO sterilization.
• Familiarity with isolators and clean rooms.
• Ability to work both independently and as part of a group.
• Good work ethic and high motivation.
• Strong organization and attention to detail.
• Excellent oral and written communication skills.
• Working knowledge of MS Office software and PC skills.
• Ability to work in a fast-paced environment and overtime as needed.
• Ability to wear laboratory protective gowning and equipment, including goggles, face shields, respirators, and protective gloves.
• Near vision of 20/40, correctable with eyeglasses or contact lenses, and color vision.
• Ability to maintain a clean-shaven appearance each working shift to properly wear tight-fitting respirators.
• Ability to occasionally lift and/or move up to 25 pounds.

Responsibilities

• Perform bacterial endotoxin testing using turbidimetric and gel-clot methods.
• Complete routine laboratory work, including reading, log-in, and water testing.
• Maintain working cultures and perform culture transfers and culture preparation.
• Set up and perform validation and routine testing of raw material, in-process, and antimicrobial effectiveness testing samples.
• Test and review completed organism identifications on Vitek.
• Perform performance qualification and validation of sterility testing.
• Assist Microbiologist I with questions about routine testing and provide training.
• Begin validation and special studies with assistance from the Microbiology Supervisor.
• Read temperature charts daily and change charts weekly.
• Maintain and analyze database data and assist with trend analysis.
• Assist with investigations and deviations and draft event reports.
• Participate in identified projects and perform other duties assigned by management.
• Ensure work is performed and documented in compliance with company policies and procedures, cGMP, and health and safety requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level