Associate II, Quality Lab,

About the Role

This 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 role, but weekend work is required to support training of analysts and to assist with projects and/or production as needed. Candidates must not be allergic to Penicillin, Cephalosporin, or their related products and/or materials.

The Quality function at Baxter values collaboration and independence. We prioritize quality over quantity, ensuring our patients come first. The team is reliable, ethical, and caring, with a culture of open dialogue, trust, and accountability. As the company evolves, so does our approach to creating top-of-the-line products.

Responsibilities

• Conduct critical chemical and physical analysis on raw materials, in-process and final products, and samples from environmental monitoring programs at the Round Lake manufacturing facility.
• Work under minimum supervision and serve as a mentor to Quality Laboratory Associate (QLA) I positions.
• Provide training and work direction for QLA I positions as required.
• Perform review of test data, including overall documentation practices, and 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 manner.
• Maintain data integrity and ensure compliance with company SOPs, FDA, GLP, QSR, and cGMP regulations.
• Participate in team-based functions impacting production, efficiency, problem-solving, cost savings, and quality improvements.
• Perform laboratory and manufacturing audits, and update plant SOPs as required.
• Perform equipment maintenance and calibrations as needed.
• Document testing completion in notebooks, controlled documents, forms, and LIMS, and maintain accurate quality records.
• Follow Baxter SOPs and policies on cGMPs and safety; maintain a clean, safe, and organized lab area.
• Investigate deviations and write exception/OOL/OOS/OOT documents.
• Support improvement projects and drive efficiency using LEAN management principles (e.g., 6S, Kaizen).
• Proactively communicate with peers and management to address progress and issues; recommend solutions.
• Maintain high standards in quality, customer service, and regulatory compliance.
• Occasional weekend work required.

Requirements

• Bachelor’s degree in Chemistry or a physical science with 2+ years of experience.
• Good oral and written communication skills, strong analytical skills, and attention to detail.
• Knowledge of current Good Manufacturing Practices (cGMP) preferred.
• Advanced laboratory skills with basic knowledge of statistical methods.
• Strong technical problem-solving skills and ability to handle multiple tasks concurrently.
• Knowledge of Empower Chromatography Data System and LIMS preferred but not required.
• Familiarity with GLP, cGMP requirements, and USP/ICH guidelines preferred but not required.
• Demonstrated ability to train others, leadership, results orientation, and task completion.
• Ability to work independently and as part of a team in a dynamic environment.
• Self-motivated, adaptable, and positive attitude.
• Ability to lift up to 50 pounds when required.
• Must not be color blind.

Benefits

• Medical, dental, and vision coverage starting on day one.
• 160 hours of paid time off and paid holidays.
• 401K match and Employee Stock Purchase Program (ESPP).
• Paid parental leave and tuition reimbursement.
• Basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Flexible Spending Accounts (FSAs) and educational assistance programs.
• Paid family and medical leaves of absence.
• Commuting benefits, Employee Discount Program, and Employee Assistance Program (EAP).
• Childcare benefits.

Pay

The estimated base salary for this position is $68,000–$93,500 annually. The range reflects anticipated salary variations based on market data and other factors, including location, skills, expertise, and experience. This position may also be eligible for discretionary bonuses.