Quality Lab Associate II

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our mission to save and sustain lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

This is where your creativity addresses challenges

You are creative, thorough, and a heads‑down do‑er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next.

The position encompasses biological, chemical, and physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming raw materials to finished goods, and environmental monitoring programs.

A candidate must not be allergic to penicillin and cephalosporin or their related products and /or materials.

6:00 PM – 6:30 AM on a rotating 2‑2‑3 schedule (including weekends).

• Conduct critical chemical and physical analysis on raw materials, initial, in‑process and final products, and samples collected from the environmental monitoring programs at the Round Lake manufacturing facility.

• Work under minimum supervision.

• Serve as mentor to Quality Laboratory Associate (QLA) I positions.

• Provide training and work direction for QLA I positions as required.

• Perform review of test data, which includes overall documentation practices.

• Perform release functions in LIMS or other computerized systems.

• Use sophisticated laboratory instrumentation (e.g., HPLC, GC) and computer systems to collect and record data.

• Perform advanced chemical assays requiring precise analytical skills and understanding of biology and chemistry principles.

• Complete all testing, including special project / protocol testing in a timely and appropriate manner.

• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.

• Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings, and improve quality.

• Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs.

• Perform equipment maintenance and calibrations as required.

• Document the completion of testing in Notebooks, Controlled documents, Forms and LIMS and maintain accurate and complete quality records.

• Follow, understand, and comply with Baxter SOPs and policies on cGMP’s and safety. Maintain a clean, safe, and organized lab area, and potentially assume responsibility to ensure that others maintain their lab areas.

• Investigate deviations and write exception/OOL/OOS/OOT documents.

• Support improvement projects and drive efficiency through utilization of LEAN management principles (i.e., 6S, Kaizen, etc.).

• Proactively and cooperatively communicate with peers and management to ensure awareness of progress and issues; recommend solutions when issues arise.

• Maintain and meet the highest standards in quality, customer service and regulatory compliance.

• Bachelor’s degree in Chemistry or physical science with 2 or more years’ experience.

• Must have good oral and written communication skills, strong analytical skills and be detail oriented.

• Knowledge of current Good Manufacturing Practices is preferred.

• Advanced laboratory skills with basic knowledge of statistical methods.

• Strong technical problem solving skills.

• Ability to handle multiple tasks concurrently, and in a timely fashion.

• Knowledge of Empower Chromatography Data System and LIMS is preferred but not required.

• Knowledge of GLP, cGMP requirements…