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Form of workJob Description
Responsibilities:
- 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 minimal to no supervision.
- Serve as mentor to Quality Laboratory Associate (QLA) I and II positions.
- Provide training and work direction for new hires.
- 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.
- Be a Subject Matter Expert (SME) on equipment and know how to troubleshoot issues.
- 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.
- 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 Systems and LIMS is preferred but not required.
- Knowledge of GLP, cGMP requirements and familiar with USP/ICH guidelines is preferred but not required.
- Must demonstrate effectiveness in ability to train others, empowerment, leadership, results orientation, and task completion.
- Ability to work independently and as part of a team, is self-motivated, demonstrates adaptability, and possesses a positive attitude in a highly dynamic environment.
- Ability to lift up to 50 pounds when required.
- Occasional weekend work required.
- Must not be color blind.
- Must not be allergic to penicillin or cephalosporin drugs.
