Microbiology Supervisor

CordenPharma South Carolina • North Augusta, SC

6d

About The Position

The Microbiology Supervisor oversees daily microbiology laboratory operations in a GMP-regulated environment. The role covers environmental monitoring, water system testing, data trending, microbiological investigations, and support for product release and stability testing. The supervisor leads and trains laboratory staff and helps ensure compliance with FDA and ICH guidelines.

The successful candidate can manage multiple projects with minimal supervision while meeting established timelines. The position requires a degree in biology, microbiology, or a related life science field, GMP experience, familiarity with applicable regulations, computer skills, and strong interpersonal and communication skills. The work involves a chemical environment and requires the ability to perform specified physical tasks and wear safety equipment in designated areas.

Requirements

• BS/BA in biology, microbiology, or a related life science field.
• 1–5 years of experience in a GMP environment.
• Familiarity with 21 CFR and ICH guidelines relating to GMPs.
• Computer skills in Microsoft Word and Excel.
• Strong written and oral communication and interpersonal skills.
• Ability to work on multiple projects with minimal supervision and meet established timelines.
• Ability to push, pull, squat, stand, and walk throughout the day.
• Ability to lift up to 50 pounds.
• Ability to wear safety shoes and glasses throughout the day in designated areas; these are provided by the company.
• Physician clearance to wear a respirator throughout the day in designated areas.
• Ability to work in a chemical environment.

Responsibilities

• Supervise all microbiology-related activities.
• Maintain schedules and perform weekly, monthly, and quarterly testing of water systems and clean rooms.
• Maintain trending data for routine water testing and clean-room environmental monitoring.
• Lead or assist with microbiology investigations, including alert and action limit excursions, out-of-specification results, out-of-trend results, and deviations.
• Procure supplies used for microbiology and QC laboratory testing.
• Train and supervise microbiologists in laboratory methodologies.
• Assist the QC/QA group with writing and editing SOPs and STPs.
• Ensure timely execution and testing of microbiology-related stability and product-release samples.
• Support and perform microbiology activities for qualification and maintenance of water systems and clean rooms.
• Perform other duties as required by Quality Control or Microbiology Management.

What This Job Offers

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