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Summary
The Quality Lab Technician will be located at the Drug Delivery Chemistry Laboratories, Round Lake, IL. The 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 third shift position but will be required to work on First and Second shifts/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.
Essential Duties and 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.
- Support improvement projects and drive efficiency through utilization of LEAN management principles (i/e/ 5S, 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.
Qualifications
- High School diploma with 0-2 years of experience. College coursework in Chemistry is preferred
- 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
- 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
- Occasional weekend work required
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the law - Poster Supplement
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.
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