Labcorp-posted about 1 year ago
$95,618 - $172,000/Yr
Full-time
Torrance, CA
Ambulatory Health Care Services

The Laboratory Systems Validation Specialist at Labcorp Central Laboratory Services LP is responsible for leading system validations for laboratory instruments, middleware, and other laboratory systems. This role involves working with laboratory instrument operations and interfaces, including Laboratory Information Systems (LIS), Laboratory Information Management Systems (LIMS), and Lab Middleware. The specialist will provide insights and guidance to ensure compliance with regulatory standards while enhancing laboratory operations.

  • Lead system validations for laboratory instruments, middleware, and other laboratory systems.
  • Work with laboratory instrument operation and interfaces, including LIS, LIMS, and Lab Middleware.
  • Provide insight and guidance on system validation processes.
  • Gather requirements and document processes in a regulatory environment.
  • Ensure compliance with 21 CFR Part 11 requirements and CAP/CLIA regulations.
  • Bachelor's degree or equivalent in System Validation, Computer Science, Clinical Research, or a related field.
  • At least 3 years of experience as a Laboratory System Analyst, Laboratory System Validation Specialist, or in a related role.
  • 3 years of experience with IT/Computer validation.
  • Experience in requirements gathering and documentation in a regulatory environment.
  • Demonstrable experience with 21 CFR Part 11 requirements and CAP/CLIA regulations.
  • Competitive salary ranging from $95,618 to $172,000 per year.
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