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Quality Laboratory Associate II

https://www.baxter.com/ Logo

Baxter

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Location:
United States, Round Lake

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Category:
Quality Control

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Contract Type:
Employment contract

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Salary:

60000.00 - 90000.00 USD / Year
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Job Description:

The position encompasses 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. This is a first shift position working onsite.

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
  • work under minimum supervision
  • serve as mentor to Quality Laboratory Associate I positions
  • provide training and work direction for Quality Laboratory Associate I positions
  • perform review of test data including overall documentation practices
  • perform release functions in LIMS or other computerized systems
  • use sophisticated laboratory instrumentation (e.g., HPLC, GC) and computer systems
  • 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
  • ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations
  • participate in team functions impacting production, increasing efficiency, solving problems
  • perform laboratory and manufacturing audits
  • audit and update plant SOPs
  • maintain quality records and lab cleanliness
  • assume responsibility for lab area's upkeep
  • investigate deviations and write exception documents
  • support improvement projects using LEAN management principles
  • communicate with peers and management to ensure awareness of progress and issues
  • recommend solutions
  • maintain the highest standards in quality, customer service, and regulatory compliance.

Requirements:

  • Bachelor degree in Chemistry or physical science with 2 or more years' experience
  • good oral and written communication skills
  • strong analytical skills
  • being detail-oriented
  • knowledge of current Good Manufacturing Practices 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 preferred but not required
  • knowledge of GLP, cGMP requirements and familiarity with USP/ICH guidelines preferred but not required
  • effectiveness in training others
  • empowerment
  • leadership
  • results orientation
  • task completion
  • ability to work independently and as part of a team
  • self-motivation
  • adaptability
  • positive attitude in a highly dynamic environment
  • ability to lift up to 50 pounds
  • not being color blind.

Nice to have:

  • Knowledge of Empower Chromatography Data System
  • Knowledge of GLP, cGMP requirements
  • familiarity with USP/ICH guidelines
What we offer:
  • Support for parents
  • continuing education/professional development
  • employee health and well-being benefits
  • paid time off
  • 2 days a year to volunteer
  • medical and dental coverage
  • insurance coverage for basic life, accident, short-term and long-term disability
  • business travel accident insurance
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan (RSP)
  • Flexible Spending Accounts
  • educational assistance programs
  • commuting benefits
  • Employee Discount Program
  • childcare benefits
  • employee assistance program.

Additional Information:

Job Posted:
March 20, 2025

Employment Type:
Fulltime
Work Type:
On-site work
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