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Quality Assurance Specialist
2 months ago
Baxter is seeking a highly skilled Quality Lab Associate II to join our team. As a key member of our quality assurance team, you will be responsible for conducting 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.
You will work under minimum supervision, serving as a mentor to Quality Laboratory Associates I and providing training and work direction as required. Your expertise will be utilized to review test data, perform release functions in LIMS or other computerized systems, and use sophisticated laboratory instrumentation to collect and record data.
The ideal candidate will possess a Bachelor's degree in chemistry or physical science, with 2 or more years of experience in a laboratory setting. You will be detail-oriented, have strong analytical skills, and be able to handle multiple tasks concurrently in a timely fashion.
Key Responsibilities- Conduct critical chemical and physical analysis on raw materials, initial, in-process, and final products, and samples collected from the environmental monitoring programs.
- Work under minimum supervision.
- Serve as mentor to Quality Laboratory Associates I.
- Provide training and work direction for Quality Lab Associate I's as required.
- Review test data and perform release functions in LIMS or other computerized systems.
- Use sophisticated laboratory instrumentation 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.
- 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.
- Investigate deviations and write exception/OOL/OOS/OOT documents.
- Support improvement projects and drive efficiency through utilization of LEAN management principles.
- Proactively and cooperatively communicate with peers and management to ensure awareness of progress and issues; recommend solutions when issues arise.
- Bachelor's degree in chemistry or physical science with 2 or more years' experience.
- 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 familiarity 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, 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.
Baxter is a global leader in developing and manufacturing life-saving medical products. Our mission is to save and sustain lives, and we are committed to making a positive impact on people around the world. We value our employees and offer a range of benefits and opportunities for growth and development.
We are an equal opportunity employer and welcome applications from diverse candidates. If you are passionate about quality and committed to excellence, we encourage you to apply for this exciting opportunity.
