Clinical Laboratory Technologist Job at Insight Global, Franklin Lakes, NJ

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  • Insight Global
  • Franklin Lakes, NJ

Job Description

Required Skills & Experience

-5 years+ experience in a Laboratory environment.

-Manual Differential testing experience

-Experience with new instrument validation/qualification as it relates to best practices for the IQ/OQ/PQ in the clinical lab -Bachelors Degree

Job Description

IG is seeking lab specialist that will be focused on supporting the development and validation of innovative in-vitro diagnostic (IVD) devices. This position plays a key role in ensuring product safety, performance, and regulatory compliance, while collaborating across departments to drive innovation. -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.

-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.

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