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Baxter International

Global provider of medical care products

Quality Lab Supervisor

Regulatory & Quality (Life Sciences)Posted on Nov 10
Full-timeRound Lake, IL, USAIn-person

About the Job

Requirements

  • A bachelor's degree in Chemistry, or a related science with Chemistry coursework, is required.
  • Four to six years of experience in the healthcare industry is required.
  • Knowledge of operating and troubleshooting laboratory instrumentation, including high-performance liquid chromatography (HPLC), ultraviolet spectroscopy (UV), infrared spectroscopy (IR), gas chromatography (GC), and mass spectrometry, is required.
  • Knowledge of quality and regulatory requirements applicable to pharmaceutical and medical device manufacturing laboratories is required.
  • Supervisory and interpersonal skills are required, along with the ability to communicate with subordinates, peers, and managers.
  • Candidates must not be allergic to penicillin, cephalosporins, or related products and materials.
  • Candidates must be authorized to work for any employer in the United States.
  • Ability to wear appropriate personal protective equipment and work around pharmaceutical materials, chemicals, and manufacturing environments is required.

Responsibilities

  • Support daily laboratory operations and workflow control, and implement testing standards and policies.
  • Conduct performance and development discussions with direct reports, provide constructive feedback, establish and document performance improvement plans when appropriate, and monitor progress.
  • Supervise laboratory safety measures and assist personnel in improving their performance.
  • Ensure timely and appropriate completion of all testing, including special project and protocol testing.
  • Assist in implementing quality and regulatory requirements, including FDA, GLP, QSR, cGMP, and USP requirements, and ensure compliance with testing standard operating procedures and specifications.
  • Monitor laboratory testing techniques and the accuracy of records and documentation.
  • Participate in initiatives that affect production, increase efficiency, solve problems, generate cost savings, improve quality, and support new products.
  • Ensure employees are properly trained and make appropriate staffing decisions.
  • Prepare, review, and revise standard operating procedures, specifications, and associated training materials; communicate changes and ensure required training updates are completed and documented.
  • Ensure equipment maintenance, calibration, and internal audits are performed on schedule.
  • Lead out-of-limit and laboratory investigations, identify root causes and corrective actions, and document outcomes accurately and promptly in the TrackWise system.
  • Review and approve laboratory records, test results, investigations, and related documentation for accuracy, completeness, data integrity, and compliance with approved procedures.
  • Mentor and develop laboratory analysts through technical coaching, troubleshooting guidance, performance feedback, and support for training and qualification activities.
  • Communicate with Manufacturing, Quality, Engineering, Supply Chain, and other support functions about testing priorities and delays, out-of-limit or atypical results, laboratory safety concerns, and potential product or production impacts; coordinate escalation, investigation support, and follow-up through resolution.

About the Company

Baxter International

Global provider of medical care products

Baxter International develops and manufactures medical products and equipment for hospitals and blood banks. Its products include sterile IV solutions and blood storage containers; innovations like the Transfuso-Vac extended blood shelf life, and a plastic blood bag helped shape modern blood banking. The company differs from competitors through a long track record of sterile manufacturing, blood-storage innovations, and strategic mergers that broaden its product portfolio. Its goal is to provide reliable, safe medical products that support patient care and hospital operations worldwide.

Company size
10,001+
Company stage
IPO
Headquarters
Deerfield, IL
Founded
1931

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