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Quality Lab Associate III - Sterility Assurance

https://www.baxter.com/ Logo

Baxter

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Location:
United States , Marion

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

80000.00 - 110000.00 USD / Year
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Job Description:

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride.

Job Responsibility:

  • Author and complete Environmental Monitoring Performance Qualifications (EMPQ) related to the manufacturing clean/classified rooms in compliance with local and regulatory requirements
  • Coordinate sampling activities with EM sampling team and manufacturing department as applicable
  • Perform Failure Modes and Effects Analysis, as needed
  • Prepare and present to management the trend reports related to EMPQ and contamination control activities
  • SME of EMPQ and contamination control aspects providing leadership, technical and quality support to manufacturing and during regulatory inspections or site audits
  • Understands and assures conformance to regulations
  • Works with regulators during regulatory inspections
  • Interacts frequently with functional peer group and managers, as appropriate
  • Identifies and leads continuous improvement projects with the objective of achieving quality, reliability, and cost improvements
  • Sustain a clean and safe work area using 6S principles
  • Learn, understand, and apply thorough quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP). Author and revise Standard Operating Procedures as needed.
  • Review and approve EMPQ and contamination control procedures, protocols, and reports
  • Perform Sterility Assurance Assessments as part of the Change Control Management process
  • Assist in establishing response plans to environmental out of limits
  • May be asked to lead classroom-based training for new employees and continuous education classes for established employees

Requirements:

  • BS degree in Biology or Microbiology
  • Five (5) or more years of professional experience in Laboratory, Quality, Manufacturing, or related field is strongly preferred
  • Strong understanding of Environmental Monitoring programs, Microbiology concepts and Good Documentation practices is preferred
  • Detailed knowledge of applicable procedures, specifications, regulations, and standards
  • Strong analytical and problem-solving skills
  • Ability to run multiple projects/investigations/priorities
  • Good communication and leadership skills
  • Good interpersonal/communication/influencing/negotiation skills
  • Good project management skills
  • Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings
  • Strong technical written skills
  • Knowledge of TrackWise Quality Management System
What we offer:
  • Medical, Dental and Vision coverage
  • 160 hours of Paid Time Off and Paid Holidays
  • 401K match
  • Employee Stock Purchase Program
  • Paid Parental Leave
  • Tuition Reimbursement
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • 2 Days a Year to Volunteer

Additional Information:

Job Posted:
January 29, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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