QC Microbiologist

Stefanini Group•Round Lake, IL

6d•Onsite

About The Position

Stefanini Group is hiring a QC Microbiologist to primarily support QC Microbiology Laboratory operations at a manufacturing facility in Round Lake, Illinois. The role supports biological testing of pharmaceutical biologics and drugs throughout manufacturing, including incoming raw materials, in-process samples, finished products, and microbiological monitoring of the facility environment and critical systems. The position is scheduled for 40 hours per week on a first shift, with a Wednesday/Thursday-to-Monday schedule. Work hours are either 7:00 AM–4:00 PM or 8:00 AM–5:00 PM, with some flexibility. Saturday and Sunday work is required, and occasional off-shift and holiday work is required. The employee may work in both Drug Delivery and Penicillin facilities as needed. Candidates 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.
Background 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 manner.
Detail-oriented and conscientious, with strong 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 dynamic environment.
Ability to lift up to 50 pounds when required.
Availability for a first-shift schedule that includes Saturday and Sunday work, with occasional off-shift and holiday work.

Nice To Haves

Knowledge of GLP and pharmaceutical aseptic processing cGMP requirements is preferred but not required.

Responsibilities

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