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Quality Assurance Specialist
2 months ago
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.
- 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.