QC Microbiologist II

American Regent•Columbus, OH

22h

About The Position

The QC Microbiologist II works in the Microbiology Laboratory and is primarily responsible for routine specialized testing, including Bacterial Endotoxin testing; validation and routine testing of Raw Material, In-Process, and Antimicrobial Effectiveness Testing samples; and assisting with the drafting of event reports. The role performs work in accordance with company policies and procedures, Current Good Manufacturing Practices, and health and safety requirements. The position also supports routine laboratory operations, organism identification review, sterility testing qualification and validation, culture maintenance, data analysis, investigations, and training. The employee may begin validation and special studies with assistance from the Microbiology Supervisor and perform other duties assigned by management.

Requirements

Bachelor’s degree in microbiology, biology, or an equivalent life science curriculum.
2–5 years of experience working in a cGMP-compliant microbiology laboratory, such as in the pharmaceutical, food, cosmetics, medical device, or laboratory pathology industries.
Strong ability to work independently and within a group.
Good work ethic and high motivation.
Organized, with strong 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.
Ability to work 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.
Must 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.

Nice To Haves

Working knowledge of biological indicators (BIs) for steam, VHP, and ETO sterilization.
Familiarity with isolators and clean rooms.

Responsibilities

Perform Bacterial Endotoxin testing by turbidimetric and gel-clot methods for products.
Complete routine laboratory work, including reading, log-in, and water testing.
Maintain working cultures and perform culture transfers and 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 PQ and validation of Sterility Testing.
Assist Microbiologist I with questions about routine testing and training.
Begin validation and special studies with assistance from the Microbiology Supervisor.
Conduct temperature chart readings daily and change charts weekly.
Maintain and analyze data in a database 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.
Perform and document all work in accordance with company policies, procedures, cGMP, and health and safety requirements.