Quality Lab Associate III

Baxter•Marion, NC

About The Position

The Quality Lab Associate III provides advanced laboratory execution, coordination, data review, and mentoring support to promote consistent performance, contamination control, and investigation readiness across microbiology laboratories. The role performs advanced microbiological testing, serves as a technical subject-matter expert and data reviewer, and supports investigations, environmental monitoring program qualification (EMPQ) activities, validations, and method qualifications. It also contributes to quality systems, audit readiness, contamination prevention, and staff development. Within Baxter’s Quality organization, this position supports products shipped worldwide and contributes to the company’s mission to save and sustain lives. The role may act as a supervisor’s delegate when assigned. Overtime is worked as required.

Requirements

  • Bachelor of Science in Microbiology or a related science, with at least 5 years of microbiology laboratory experience and demonstrated technical mastery appropriate to the level; alternatively, a high school diploma, at least 7 years of microbiology laboratory experience, completion of an approved training curriculum, and demonstrated technical mastery appropriate to the level.
  • Expert-level technical knowledge of microbiology laboratory operations and methods relevant to assigned sub-departments.
  • Demonstrated ability to act as a technical authority and primary data reviewer for complex or high-risk testing activities.
  • Strong project management skills, including scope definition, timeline management, tracking, reporting, and sustaining outcomes.
  • Advanced investigation and root-cause analysis skills, including evidence evaluation, effective CAPA development, and effectiveness assessment.
  • Ability to analyze, trend, and interpret laboratory and process data to identify systemic risks and improvement opportunities.
  • Excellent technical writing skills for investigations, CAPAs, SOPs, protocols, and reports.
  • Ability to influence cross-functional stakeholders and drive alignment on quality and contamination-control decisions.
  • Demonstrated mentoring and leadership skills, including developing junior analysts and technicians.
  • Strong judgment and decision-making skills in complex or ambiguous situations.
  • Proficiency in regulatory and quality systems expectations, including GMP, data integrity, and inspection readiness.
  • Must be authorized to work for any employer in the United States; visa sponsorship is not available.

Responsibilities

  • Perform advanced microbiological testing and support cross-laboratory workflows.
  • Serve as a primary technical subject-matter expert and data reviewer.
  • Own microbial investigations or EMPQ activities as assigned.
  • Perform advanced data trending, statistical analysis, and KPI reporting.
  • Consult on CAPAs and effectiveness checks.
  • Lead validations and method qualifications.
  • Mentor laboratory staff and support the supervisor and manager.
  • Represent the laboratory during audits and regulatory inspections.
  • Act as a delegate for the supervisor as assigned.
  • Embed contamination-control principles into system design and process changes.
  • Influence site-wide contamination-prevention behaviors.

Benefits

  • Medical coverage
  • Dental coverage
  • Vision coverage
  • 160 hours of paid time off and paid holidays
  • 401(k) match
  • Employee Stock Purchase Program
  • Paid parental leave
  • Tuition reimbursement
  • Basic life insurance
  • Accident insurance
  • Short-term disability insurance
  • Long-term disability insurance
  • Business travel accident insurance
  • Flexible Spending Accounts
  • Educational assistance programs
  • Family and medical leaves of absence
  • Commuting benefits
  • Employee Discount Program
  • Employee Assistance Program
  • Childcare benefits
  • May be eligible for discretionary bonuses
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