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Quality Manager

https://www.baxter.com/ Logo

Baxter

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Location:
United States , Round Lake

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Category:
-

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Contract Type:
Employment contract

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Salary:

112000.00 - 154000.00 USD / Year
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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:

  • Provide direct Quality Assurance oversight of cephalosporin manufacturing operations across assigned areas and shifts
  • Ensure strict adherence to cephalosporin segregation, contamination control, and cleaning validation requirements
  • Review and approve GMP documentation, including batch records, deviations, investigations, and change controls
  • Support batch disposition activities and ensure timely, compliant release decisions
  • Identify, assess, and escalate quality and compliance risks impacting product quality or patient safety
  • Lead deviation, NCR, CAPA, complaint, and change control processes to ensure thorough, timely, and risk‑based outcomes
  • Monitor and trend quality metrics to identify performance gaps and emerging risks
  • Maintain continuous inspection readiness and participate in regulatory inspections as a Quality subject‑matter expert
  • Collaborate cross‑functionally with Manufacturing, Engineering, Maintenance, Facilities, Planning, and Microbiology
  • Provide QA support for equipment qualification, process changes, and technical improvement initiatives
  • Lead, coach, and develop a team of Quality professionals, setting clear expectations for performance and compliance
  • Drive continuous improvement initiatives that enhance compliance, reliability, and operational efficiency

Requirements:

  • Bachelor’s degree in Science, Engineering, or a related discipline required
  • Minimum of 5 years of experience in Quality or a related field, with prior experience in pharmaceutical or medical device environment required
  • 1–2 years of people leadership or supervisory experience required
  • Demonstrated knowledge of cGMP regulations (FDA, EU, PIC/S) and quality systems
  • Experience with batch record review, deviations, investigations, and CAPA management
  • Strong understanding of contamination control and manufacturing compliance principles
  • Experience supporting cephalosporin, sterile, injectable, or highly potent manufacturing operations
  • Strong analytical, problem‑solving, and risk‑assessment skills
  • Effective communication and collaboration skills across cross‑functional teams
  • Ability to manage multiple priorities and lead initiatives in a fast‑paced manufacturing environment
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 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 (RSP)
  • 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

Additional Information:

Job Posted:
April 24, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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