Quality Lab Associate I, Microbiology

Your Role at Baxter

You will primarily support Microbiology Laboratory operations at the Round Lake Manufacturing facility in Round Lake, IL. This position encompasses biological testing support for pharmaceutical products (biologics and drugs) through all stages of the manufacturing process including incoming raw materials, in-process samples and finished product and includes facility environmental and critical systems microbiological monitoring. This is a first-shift Tuesday-Saturday position. Occasional off-shift and holiday work required.

What you'll be doing

• Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.
• Support improvement projects and drive efficiency through utilization of LEAN management principles (i.e. 5S, Kaizens, etc).
• Proactively and cooperatively communicate with peers and management to ensure awareness of progress and issues; recommend solutions when issues arise.
• Conduct biological testing on raw materials, initial, in-process and final products and samples collected from environmental monitoring programs at Baxter manufacturing facilities.
• Work under minimum supervision.
• Perform sterility or endotoxin testing of final product.
• Conduct routine facility environmental monitoring (i.e. surfaces, air, particulate and personnel monitoring) and critical systems monitoring (water, clean steam, process compressed air and nitrogen).
• Prepare media and reagents used within the laboratory.
• Use laboratory instrumentation (i.e. particle counters, pH meter, SAS, Autoclave) and computer systems (i.e. LIMS) to collect and record data.
• Monitor inventory of supplies, equipment, reagents and media.
• Order, receive and stock supplies as necessary.
• Perform routine preventative maintenance activities.
• Maintain a clean, safe and organized lab area and perform regular laboratory housekeeping activities.
• Author laboratory investigations and procedures.
• Perform revisions of laboratory procedures.
• Perform laboratory and manufacturing audits as required.
• Audit and update, as required, plant SOPs.
• Prepare data and trend analysis, numerically and graphically, for monthly and quarterly quality system reports.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, QSR and cGMP regulations.
• Follow, understand and comply with Baxter SOP’s and policies on cGMP’s and safety.
• Contribute to other laboratory tasks and projects as assigned.
• Will work in both Drug Delivery and Penicillin facilities as needed.

What you'll bring

• Must not be allergic to Penicillin and Cephalosporin or their related products and minerals.
• Bachelors Degree in microbiology or equivalent with biology/microbiology laboratory setting coursework and 0-2 years experience in a laboratory setting.
• Proficient in LIMS (laboratory information management systems).
• Background knowledge in basic Biology and Microbiology principles including aseptic technique is required.
• Knowledge of GLP and pharmaceutical aseptic processing cGMP requirements is preferred but not required.
• Ability to handle multiple tasks concurrently and in a timely fashion.
• Must be detail oriented, conscientious and have high reading comprehension skills.
• 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.