Associate II, Quality Lab

Job Title

Your Role at Baxter

This is where your creativity addresses challenges

The Position encompasses the 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.

This is a first shift position but will be required to work on weekends to support training of analysts and to support projects and/or production, as required. A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials.

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

• Medical, Dental and Vision coverage
• 160 hours of Paid Time Off and Paid Holidays
• 401K match
• Employee Stock Purchase Program
• Paid Parental Leave
• Tuition Reimbursement

• 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 SOP's 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 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 and familiarity with USP/ICH guidelines is preferred but not required.
• Must demonstrate effectiveness in ability to train others, empowerment,…