QC Microbiologist

Stefanini Group•Round Lake, IL

5d•Onsite

About The Position

The QC Microbiologist primarily supports QC Microbiology Laboratory operations at a manufacturing facility in Round Lake, Illinois. The role provides biological testing support for pharmaceutical biologics and drugs at all stages of manufacturing, including incoming raw materials, in-process samples, and finished products. It also includes microbiological monitoring of the facility environment and critical systems. The position works in both Drug Delivery and Penicillin facilities as needed. The schedule is first shift, 40 hours per week, with work Wednesday or Thursday through Monday. Saturday and Sunday hours are required, and occasional off-shift and holiday work is required. The shift is flexible between 7:00 AM–4:00 PM and 8:00 AM–5:00 PM. The employee must not be allergic to penicillin, cephalosporin, or related products and minerals. Showers are required when leaving the facility.

Requirements

Bachelor's degree in microbiology or biological science.
At least 2 years of experience in a laboratory setting.
Must not be allergic to penicillin, cephalosporin, or related products and minerals.
Knowledge of basic biology and microbiology principles, including aseptic technique.
Proficiency in laboratory information management systems (LIMS).
Ability to handle multiple tasks concurrently and in a timely fashion.
Detail-oriented and conscientious, with high reading comprehension skills.
Demonstrated technical writing skills and knowledge of structured root cause investigation methodologies, including DMAIC (Define, Measure, Analyze, Improve, Control).
Ability to work independently and as part of a team.
Self-motivation, adaptability, and a positive attitude in a highly dynamic environment.
Ability to lift up to 50 pounds when required.
Availability for the stated first-shift schedule, including weekend hours and occasional off-shift and holiday work.

Nice To Haves

Knowledge of GLP and pharmaceutical aseptic processing cGMP requirements.

Responsibilities

Conduct microbial analyses on raw materials, in-process samples, finished products, environmental monitoring samples, and samples collected from the manufacturing facility.
Conduct routine facility environmental monitoring, including surfaces, air, particulate, and personnel monitoring.
Monitor critical systems, including water, clean steam, process compressed air, and nitrogen.
Prepare media and reagents used in the laboratory.
Use laboratory instrumentation and computer systems to collect and record data.
Monitor inventory of supplies, equipment, reagents, and media; order, receive, and stock supplies as necessary.
Maintain a clean, safe, and organized laboratory area and perform regular housekeeping activities.
Conduct and document laboratory and nonconformance investigations, including data review, root cause analysis, impact assessment, and corrective and preventive actions.
Maintain data integrity and ensure compliance with company procedures and FDA, QSR, and cGMP regulations.
Follow, understand, and comply with client procedures and policies on cGMP and safety.
Contribute to other laboratory tasks and projects as assigned.