Quality Lab Associate I

DivIHN Integration • Round Lake, IL

9d • Onsite

About The Position

Primarily supports QC Microbiology Laboratory operations at the client’s manufacturing facility in Round Lake, Illinois. The role provides biological testing support for pharmaceutical biologics and drugs throughout manufacturing, including incoming raw materials, in-process samples, and finished products. It also includes facility environmental and critical-systems microbiological monitoring. The position focuses on routine QC microbiology testing in a pharmaceutical or aseptic manufacturing environment and works in both Drug Delivery and Penicillin facilities as needed.

This is a 12-month, first-shift role with a Wednesday–Sunday schedule or, with some flexibility, a Thursday–Monday schedule. Listed hours are 7:00 AM–3:30/4:00 PM or 8:00 AM–5:00 PM. Saturday and Sunday work is required, with occasional off-shift and holiday work. The incumbent must not be allergic to Penicillin, Cephalosporin, or related products and minerals, and showers are required when leaving the facility. Only W2 candidates are eligible; third-party and C2C candidates will not be considered.

Requirements

• Bachelor’s degree in science is required; a bachelor’s degree in microbiology or biological science is specified, with Biology or Microbiology preferred. A master’s degree is acceptable; a Ph.D. is considered overqualified.
• A minimum of two years of experience in a laboratory setting is specified. The posting ideally seeks one to two years in aseptic or pharmaceutical microbiology and says candidates with roughly one to five years may be considered.
• Basic knowledge of biology and microbiology principles, including aseptic technique.
• Proficiency with laboratory information management systems (LIMS).
• Ability to manage multiple tasks concurrently and in a timely manner.
• Detail-oriented, conscientious, and 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.
• Must not be allergic to Penicillin, Cephalosporin, or their related products and minerals.
• Ability to work the stated weekend schedule, with occasional off-shift and holiday work.

Nice To Haves

• Knowledge of GLP and pharmaceutical aseptic-processing cGMP requirements.
• Aseptic or pharmaceutical microbiology experience.

Responsibilities

• Conduct microbial analyses on raw materials, in-process and finished products, and samples collected through environmental monitoring programs and at the manufacturing facility.
• Conduct routine facility environmental monitoring of surfaces, air, particulates, and personnel, as well as critical-systems monitoring of water, clean steam, process compressed air, and nitrogen.
• Prepare media and reagents for laboratory use.
• Use laboratory instrumentation and computer systems, including particle counters, pH meters, SAS, autoclaves, and LIMS, to collect and record data.
• Monitor laboratory supply, equipment, reagent, and media inventory; order, receive, and stock supplies as needed.
• Maintain a clean, safe, and organized laboratory and perform routine housekeeping.
• 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 requirements, as well as client procedures and safety policies.
• Contribute to other laboratory tasks and projects as assigned.

What This Job Offers

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