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This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives. The Position encompasses 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.
Job Responsibility:
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 minimum supervision
Serve as mentor to Quality Laboratory Associate (QLA) I positions
Provide training and work direction for QLA I positions as required
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
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
Requirements:
Bachelor 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 System 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
Rotating weekend work required
Visual acuity 20/25 Near Vision with or without corrective vision required
Must not be color blind
Must not be allergic to Penicillin, Cephalosporins, or their related products and /or materials
A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials
Nice to have:
Knowledge of current Good Manufacturing Practices
Knowledge of Empower Chromatography Data System and LIMS
Knowledge of GLP, cGMP requirements and familiarity with USP/ICH guidelines
What we offer:
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service