Added
17 days ago
Type
Full time
Salary
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documentation validation hl7 gxp lims
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📋 Description

  • Lead UAT for LIS, middleware, and instrument interfaces
  • Develop UAT strategies, plans, scripts, and acceptance criteria
  • Partner with lab stakeholders to reflect real workflows
  • Track defects and coordinate with IT and vendors
  • Plan and execute system validation per GxP, CLIA, CAP, FDA
  • Ensure traceability from requirements to test outcomes

🎯 Requirements

  • Bachelor’s or Master’s in Clinical Lab Science, Life Sciences, or related
  • 5-8 years in clinical labs, informatics, or business analysis
  • Strong LIS/LIMS, middleware, and instrument interfaces
  • UAT coordination and execution experience
  • System validation in regulated environments (GxP, CLIA, CAP, FDA)
  • Authoring validation and regulatory documentation
  • Familiarity with LIS platforms (Epic Beaker, SCC Soft, Sunquest, Cerner)

🎁 Benefits

  • Discretionary annual bonus
  • Health insurance
  • Retirement savings benefits
  • Life insurance
  • Disability benefits
  • Paid time off for sick leave and vacation
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