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Quality Associate III - QC Microbiology

https://www.baxter.com/ Logo

Baxter

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Location:
United States , Round Lake

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Category:
IT - Software Development

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Contract Type:
Not provided

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Salary:

96000.00 - 132000.00 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:

  • Support and guide QC Microbiology activities at RLDD, including environmental monitoring, contamination control, and laboratory operations
  • Contribute to validation and lifecycle activities for microbiological methods, instruments, and laboratory systems, including qualifications, method transfers, and change assessments
  • Partner with cross-functional teams to evaluate microbiological risks, support issue resolution, and inform product quality decisions
  • Lead and support investigations (e.g., deviations, atypical results, EM excursions) using structured, science-based approaches to determine root cause and implement effective corrective actions
  • Prepare and maintain microbiology documentation such as SOPs, test methods, protocols, and contamination control strategy content, ensuring clarity and compliance with regulatory expectations
  • Perform laboratory assessments and data reviews to identify improvement opportunities and sustain a state of inspection readiness
  • Support adoption and continuous improvement of laboratory tools and systems (e.g., LIMS, EM systems, data trending tools) to strengthen efficiency and data integrity
  • Share knowledge and provide guidance to colleagues
  • contribute to audits and inspections by preparing documentation and responding to microbiology-related inquiries

Requirements:

  • Bachelor's degree in Microbiology, Biology, Chemistry, or a related scientific field with 8+ years of experience in a regulated pharmaceutical or medical device environment, OR Master's degree in a related field with 5+ years of relevant experience
  • Experience with microbiological testing and environmental monitoring, particularly in regulated settings
  • Familiarity with investigation processes (e.g., OOS, OOT, or atypical results) and structured problem-solving approaches
  • Ability to develop and maintain GMP-compliant documentation (e.g., SOPs, test methods, protocols)
  • Working knowledge of cGMP and regulatory expectations, including data integrity principles
  • Experience using laboratory systems (e.g., LIMS or similar tools)
  • Clear communication skills with the ability to present technical information in an understandable way
  • Strong organizational skills and the ability to manage multiple responsibilities effectively
  • Experience in sterile manufacturing or contamination control environments
  • Exposure to regulatory inspections or audits within a microbiology function
  • Experience supporting implementation of new laboratory systems, tools, or process improvements
  • Interest in mentoring or sharing knowledge with team members
  • Familiarity with data analysis, trending tools, or digital laboratory solutions

Nice to have:

  • Experience in sterile manufacturing or contamination control environments
  • Exposure to regulatory inspections or audits within a microbiology function
  • Experience supporting implementation of new laboratory systems, tools, or process improvements
  • Interest in mentoring or sharing knowledge with team members
  • Familiarity with data analysis, trending tools, or digital laboratory solutions
What we offer:
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Health & 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)
  • 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
  • paid parental leave
  • commuting benefits
  • Employee Discount Program
  • Employee Assistance Program (EAP)
  • childcare benefits

Additional Information:

Job Posted:
May 15, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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