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Quality Assurance Specialist

2 months ago


Round Lake Beach, Illinois, United States BAXTER Full time
About the Role

We are seeking a highly skilled and detail-oriented Quality Assurance Specialist to join our team at Baxter. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and safety of our products.

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 and serve as a mentor to junior laboratory staff.
  • Provide training and work direction for laboratory staff as required.
  • Perform review of test data, including overall documentation practices.
  • Perform release functions in laboratory information management systems (LIMS) or other computerized systems.
  • Use sophisticated laboratory instrumentation 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 standard operating procedures (SOPs) and specifications, FDA, Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and current Good Manufacturing Practice (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 SOPs and policies on cGMPs and safety. Maintain a clean, safe, and organized laboratory area, and potentially assume responsibility to ensure that others maintain their laboratory 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.
Requirements
  • Bachelor's degree in chemistry or physical science with 2 or more years' experience.
  • 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 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.