IG is seeking a lab specialist that will focus 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.
Base Pay Range
$35.00/hr - $40.00/hr
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.
- 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.
Required Skills and 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 IQ/OQ/PQ in the clinical lab.
- Bachelor's Degree.
Seniority Level
Mid‑Senior Level
Employment Type
Contract
Job Function
Science
Job Location
Franklin Lakes, NJ
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