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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