Job Description
Job Description
Title: Quality Lab Associate I
Location: Round Lake, IL
Work Arrangement: Onsite
Shift: 1st Shift, 8:00 AM – 5:00 PM
Schedule: Flexible Monday through Sunday, with Saturday and Sunday hours required. The position is primarily Thursday through Monday.
Pay Rate: $25/HR
Job Summary
The QC Microbiology Laboratory Technician will primarily support Quality Control (QC) Microbiology Laboratory operations at the Manufacturing facility in Round Lake, IL. This role involves biological testing of pharmaceutical products, including biologics and drugs, throughout the manufacturing process, including incoming raw materials, in-process samples, and finished products. The position also supports facility environmental monitoring and critical systems microbiological monitoring.
Essential Duties and Responsibilities
- Perform microbial analyses on raw materials, in-process samples, finished products, and samples collected through environmental monitoring programs at the Baxter manufacturing facility.
- Conduct routine environmental monitoring, including surface, air, particulate, and personnel monitoring, as well as critical systems monitoring of water, clean steam, process compressed air, and nitrogen.
- Prepare laboratory media and reagents required for microbiological testing.
- Operate laboratory instruments, including particle counters, pH meters, SAS equipment, and autoclaves, and use laboratory information management systems (LIMS) to collect and record data.
- Monitor inventory of laboratory supplies, equipment, reagents, and media; order, receive, and stock materials as needed.
- Maintain a clean, safe, and organized laboratory environment and perform routine housekeeping activities.
- Conduct and document laboratory and nonconformance investigations, including data review, root cause analysis, impact assessments, and the development of appropriate corrective and preventive actions.
- Maintain data integrity and ensure compliance with company standard operating procedures, FDA requirements, QSR, and cGMP regulations.
- Follow Baxter procedures and policies related to cGMP and laboratory safety.
- Support additional laboratory tasks and projects as assigned.
- Work in both Drug Delivery and Penicillin facilities as required.
Qualifications
- Must not have allergies to penicillin, cephalosporins, or their related products and minerals.
- Basic knowledge of biology and microbiology principles, including aseptic techniques.
- Proficiency in Laboratory Information Management Systems (LIMS).
- Ability to manage multiple tasks simultaneously and complete work within established timelines.
- Strong attention to detail, conscientiousness, and reading comprehension skills.
- Knowledge of Good Laboratory Practices (GLP) and pharmaceutical aseptic processing cGMP requirements is preferred but not required.
- Demonstrated technical writing skills and knowledge of structured root cause investigation methodologies, including DMAIC (Define, Measure, Analyze, Improve, Control).
- Ability to work independently and collaboratively in a team environment.
- Self-motivated, adaptable, and able to maintain a positive attitude in a dynamic work environment.
- Ability to lift up to 50 pounds when required.
- Willingness to work occasional off-shift hours and holidays.
- Must be willing to shower when leaving the facility.
Education and Experience
- Bachelor's degree in Microbiology or Biological Science.
- Minimum of two years of experience in a laboratory setting.
Additional Requirements
- Onsite work is required.
- Weekend and holiday work is required.
- The position follows a first-shift schedule, with the primary schedule being Thursday through Monday.
- The employee may be required to work in both Drug Delivery and Penicillin facilities.