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The Quality Lab Associate I 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.
Job Responsibility:
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
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
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
Maintain and meet the highest standards in quality, customer service and regulatory compliance
Requirements:
Bachelor's degree in chemistry or science related degree with 6 months or more of experience
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 pounds when required
Must not be color blind
20/20 vision with or without correction
A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials
Nice to have:
Knowledge of Empower CDS and LIMS
Knowledge of GLP, cGMP requirements and familiar 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