Quality Laboratory Associate II

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. 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. 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.