QC Microbiologist II — Endotoxin & GMP Lab Expert

americanregent; Columbus (OH); On-site; USD 60,000 - 90,000; Full time

Job summary

American Regent is seeking a Microbiology Laboratory professional to lead routine specialized testing including Bacterial Endotoxin and validation of material samples. The role involves maintaining cultures, performing inoculations, and supporting testing across Raw Material, In-Process, and antimicrobial effectiveness studies.

The candidate should have a 2–5 year track record in a cGMP microbiology lab, strong attention to detail, and excellent communication skills.

Qualifications

• Bachelor's degree in microbiology, Biology, or equivalent Life Science curriculum required.
• Minimum of 2-5 years' experience working in a cGMP compliant Microbiology Laboratory (i.e. pharmaceutical industry, food industry, Cosmetics, medical devices, Laboratory Pathology).
• Strong ability to work both independently and within a group.
• Good work ethic and highly motivated.
• Organized individual with strong attention to detail.
• Excellent communication skills (oral and written).
• Working knowledge of MS-Office software and PC Skills Required.
• Ability to work in a fast-paced environment.
• Ability to work overtime as needed.

Responsibilities

• Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices, health and safety requirements.
• Perform Bacterial Endotoxin testing by Turbid metric and Gel clot for products.
• Ensure all routine lab work such as reading, log in, water testing is completed.
• Maintenance of working cultures, culture transfer, 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.
• PQ and Validation of Sterility Testing.
• Assist Microbiologist I with any questions regarding routine testing and training.
• Begin validation and special studies with the assistance of Microbiology Supervisor.
• Conducts temperature chart readings daily and changing chart weekly.
• Maintain and analyze data in database and assist in performance of trend analysis.
• Assist in the investigation/deviation and drafting of event reports.
• Working knowledge of BIs for steam, VHP and ETO sterilization.
• Familiarity with Isolator's as well as clean rooms.
• Participate in identified projects.
• Perform any other tasks/duties as assigned by management.

Skills

Communication skills

MS-Office

Education

Bachelor's degree in microbiology

Job description

American Regent is seeking a Microbiology Laboratory professional to lead routine specialized testing including Bacterial Endotoxin and validation of material samples. The role involves maintaining cultures, performing inoculations, and supporting testing across Raw Material, In-Process, and antimicrobial effectiveness studies.

The candidate should have a 2–5 year track record in a cGMP microbiology lab, strong attention to detail, and excellent communication skills.