Laboratory Technologist

2 weeks ago

Franklin Square, New York, United States Insight Global Full time

Lab Technologist – Clinical Laboratory & IVD Validation

Location:
On-site

Type:
Contract (1 year with extensions)

Shift:
Standard business hours (M–F)

Pay Range:
$36–$40/hour (depending on experience)

A leading innovator in the in-vitro diagnostics (IVD) space is seeking a
Lab Technologist
to support the development and validation of cutting-edge diagnostic devices. This role is ideal for professionals with deep clinical lab experience and a passion for driving innovation in healthcare technology.

Key Responsibilities

  • Support the design, testing, and reporting of new or updated IVD devices.
  • Operate and maintain a variety of lab instruments and platforms.
  • Lead and manage clinical studies and complaint investigations.
  • Collaborate with R&D to develop and implement new testing methods.
  • Conduct Clinical Software Validations (CSV) and instrument qualification (IQ/OQ/PQ).
  • Apply quality and regulatory standards (GLP, GCP, ISO) to lab processes.
  • Troubleshoot technical issues using scientific judgment.
  • Work cross-functionally with teams in manufacturing, marketing, quality, and regulatory.

Must-Have Qualifications:

  • 5+ years of experience in a clinical laboratory environment.
  • Hands-on experience with
    manual differential testing
    .
  • Urinalysis
    testing
    experience
  • Proven track record in
    instrument validation/qualification
    (IQ/OQ/PQ).
  • Bachelor's or Master's degree in Clinical Laboratory Science, Medical Technology, Biology, Life Sciences, or a related health field.

Preferred Skills & Technologies:

  • Familiarity with IVD platforms and lab automation systems.
  • Knowledge of regulatory frameworks:
    GLP (Good Laboratory Practice), GCP (Good Clinical Practice), ISO standards
    .
  • Experience with CSV (Clinical Software Validation).
  • Strong documentation and reporting skills.

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