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LALabcorp

Laboratory Systems Validation Specialist I(m/w/x)

Genf
Full-timeOn-siteExperienced

Leading system validations for LIS/LIMS and middleware platforms in a global laboratory services provider. 3+ years in a validation role with a BS degree required. Support client audits with system validation documentation.

Requirements

  • 3+ years in Laboratory System Analyst or Validation role
  • BS in Clinical Lab Science, Biology, Chemistry, Public Health, Microbiology, Computer, Technology, Animal Science, or Medical Technology
  • 1+ years knowledge of lab workflow and processes
  • 1+ years experience in laboratory software testing
  • 1+ years experience supporting client audits with system validation documentation
  • Experience in IT/Computer validation
  • Experience in requirements gathering and documentation in regulatory environment
  • Strong knowledge of 21 CFR Part 11 and CAP/CLIA regulations
  • Background in information systems, data analysis, workflow analysis
  • Effective communication with clients at all organizational levels

Tasks

  • Operate and support laboratory instruments
  • Support LIS/LIMS and middleware platforms
  • Lead system validations for lab systems
  • Guide team during system validations
  • Support change control processes
  • Collaborate with SMEs to define system behaviors
  • Translate system behaviors into technical requirements
  • Provide technical consultation to clients
  • Gather and document system requirements
  • Create and maintain validation documentation
  • Lead testing activities for lab workflows
  • Test physical automation and instrument middleware
  • Oversee middleware interface development requirements
  • Coordinate with project managers for system testing
  • Ensure timely service delivery
  • Maintain strong client relationships
  • Drive client satisfaction
  • Identify business opportunities
  • Monitor system testing progress
  • Track performance metrics
  • Escalate issues as needed
  • Review and prepare test results for QA
  • Ensure complete and compliant test packages
  • Balance operational and project duties
  • Allocate resources to meet performance standards
  • Maintain regulatory compliance
  • Collaborate with other sites and teams
  • Perform qualification specialist duties
  • Review and approve validation documentation
  • Archive validation documentation
  • Provide updates to project managers and leadership
  • Complete HR and training requirements
  • Maintain an up-to-date training file
  • Submit monthly status reports
  • Support continuous improvement and quality

Work Experience

  • 3 years

Education

  • Bachelor's degree

Languages

  • EnglishBusiness Fluent

Tools & Technologies

  • Navify
  • FCS Express
  • Infinicyte
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Labcorp and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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