Quality Lab Associate, Baxter

Baxter

Location:
United States, Round Lake

Category:
Quality Control

Contract Type:
Employment contract

Salary:

64000.00 - 96000.00 USD / Year

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Job Description:

This position involves the biological, chemical, and physical analyses on pharmaceutical products through all stages of the manufacturing process from incoming raw materials to finished goods, and environmental monitoring programs. It requires skills in laboratory instrumentation, regulatory compliance, and teamwork.

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
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, 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.

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
occasional weekend work required.

Nice to have:

knowledge of Empower CDS and LIMS
knowledge of GLP, cGMP requirements and familiarity with USP/ICH guidelines

What we offer:

medical and dental coverage starting 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
flexible spending accounts
educational assistance programs
paid holidays and paid time off ranging from 20 to 35 days based on length of service
family and medical leaves of absence
paid parental leave
commuting benefits
employee discount program
employee assistance program (EAP)
childcare benefits.

Additional Information:

Job Posted:
March 20, 2025

Employment Type:

Fulltime

Work Type:

On-site work

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Quality Lab Associate