Quality Lab Associate I (6am-6:30pm)

Summary: Baxter International Inc. is a company dedicated to redefining healthcare delivery and making a greater impact. The Quality Lab Associate I will conduct critical chemical and physical analyses on pharmaceutical products throughout the manufacturing process, ensuring compliance with regulatory standards and maintaining data integrity. Responsibilities: - Conduct critical chemical and physical analyses on Raw Materials, Initial, In-process and Final products, and samples collected from environmental monitoring programs at Baxter manufacturing facilities. Work under minimum supervision - Use sophisticated laboratory instrumentation (HPLC, FTIR, UV, GC etc) and computer systems to collect and record data - Perform advanced assays requiring precise analytical skills and understanding of biology and chemistry principles - 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, Kaizens 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 - Other projects as assigned Required Qualifications: - Bachelors degree in Chemistry or Science related degree with 6 months or more of experience - A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials - Excellent communication (oral and written) and interpersonal 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 pound when required - Rotating weekend work required - Visual acuity 20/20 Near Vision with or without corrective vision required - Must not be color blind Preferred Qualifications: - Knowledge of Empower CDS and LIMS is preferred but not required - Knowledge of GLP, cGMP requirements and familiar with USP/ICH guidelines is preferred but not required Required Skills: HPLC, GLP, cGMP Important Skills: LIMS, Empower CDS Nice-to-Have Skills: communication, Teamwork, Self-motivation, Adaptability, Positive attitude Benefits: Medical and dental coverage that start on day one, Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance, Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching, Flexible Spending Accounts, Educational assistance programs, Paid holidays, Paid time off ranging from 20 to 35 days based on length of service, Family and medical leaves of absence, Paid parental leave, Commuting benefits, Employee Discount Program, Employee Assistance Program (EAP), Childcare benefits