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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 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:

  • 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

Additional Information:

Job Posted:
January 30, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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