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Baxter Logo Baxter · Quality Control

Quality Associate II

United States, Round Lake Employment contract 88000.00 - 121000.00 USD / Year · Job Posted June 09, 2026
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Job Description

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.

Job Responsibility

  • Primary responsibility for the execution and management of the internal audit process at Round Lake Drug Delivery ensuring compliance with all applicable provisions of Baxter’s Quality System, and the regulations and standards applicable to RLDD operations
  • Schedules and plans for the audit activity by researching background information, including previous audit results. Plans and develops assessment strategy and logistics
  • Performs internal audits, either individually or as a team lead/participant, by collecting and analyzing objective evidence regarding issues and risks. Reports findings (verbally and written) to management
  • Evaluates corrective and preventive action responses to the audit findings for adequacy, including root cause determination and timeliness. Escalates issues to management as appropriate. Tracks and reports on commitment status through closure
  • Manages the audit file through the entire process to closure. Prepares summary reports depicting results and trends for management review purposes
  • Performs follow-up audits, when applicable, to confirm corrective and preventive action is effective
  • Trains and mentors new auditors and manages the guest auditor program
  • Supports management of external inspections. Tracks and reports the status of external commitments through closure
  • Schedules and coordinates Management Review and Quality Data Review meetings, including publishing of summaries of the data presented, conclusions, and meeting minutes as required. Documents and tracks action items and follow-up commitments to closure
  • Leads and manages multiple projects/teams including corporate quality policy & procedure gap analysis and implementation, the global audit observation certification process, Annual Product Reviews, SOP and training code audits, and other quality system improvement projects
  • Remains current in regulatory trends and requirements through attendance at related conferences, seminars, meetings, and other training methods such as independent study of periodicals, Internet, or other industry literature

Requirements

  • BS in business/science or equivalent degree
  • 3 or more years of experience in Quality with a pharmaceutical or medical device company, or other similarly regulated industry
  • Previous auditing experience required, and ASQ and/or other accreditation is highly desirable
  • Strong interpersonal skills and great attention to detail are necessary
  • Must be a team player with good problem solving, and good verbal and written communication skills
  • Must be able to handle multiple projects concurrently
  • Computer skills/experience using MS Office, TrackWise, Cornerstone, or similar systems is highly desirable
  • Must have knowledge of and experience with FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
  • Knowledge of and experience with outside the US regulatory requirements is desirable
  • A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials
  • Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Nice to have

  • ASQ and/or other accreditation
  • Computer skills/experience using MS Office, TrackWise, Cornerstone, or similar systems
  • Knowledge of and experience with outside the US regulatory requirements

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), with the ability to purchase company stock at a discount
  • 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
  • Flexible Spending Accounts
  • educational assistance programs
  • time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
  • commuting benefits
  • Employee Discount Program
  • Employee Assistance Program (EAP)
  • childcare benefits
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