Clinical Lab Specialist

1 day ago

Franklin Lakes, United States CYNET SYSTEMS Full time

Job Description: Pay Range: $50.57hr - $53.57hr The Clinical Lab Specialist supports scientific investigations, conducts clinical testing, maintains laboratory instrumentation, and ensures compliance with quality and regulatory standards. This role contributes to clinical strategy, supports product development, and provides clinical expertise across multiple projects. Requirement/Must Have: Ability to conduct scientific investigations and recommend solutions. Experience adapting methodologies for clinical laboratory needs. Ability to conduct clinical testing and maintain instrumentation and reagent systems. Experience implementing and documenting QA/QC procedures. Ability to perform instrument verification per guidelines and assist with procedure updates. Experience performing Clinical Software Validations and instrument validation/qualification. Ability to stay current with clinical laboratory science developments. Ability to train new associates on laboratory workflow. Ability to identify laboratory practice trends and recommend projects. Experience supporting clinical strategy and generating scientific information for products. Ability to resolve customer complaints through clinical investigations. Ability to support innovation, product development, clinical testing, manufacturing, and post-market activities. Experience: 5+ years of experience in a clinical laboratory environment. Experience in clinical laboratory testing, blood collection, urinalysis, and LIS/LIMS systems. Experience conducting or supporting clinical investigations. Experience supporting multiple clinical projects. Responsibilities: Conduct scientific investigations and recommend concepts and principles. Adapt methodologies for core clinical laboratory operations. Conduct clinical testing and maintain instrumentation and inventory. Implement and document QA/QC procedures. Perform instrument verification and assist with procedure and documentation updates. Conduct Clinical Software Validations and support instrument qualification activities. Participate in continued education and stay updated on laboratory science Train new laboratory associates. Monitor laboratory trends and recommend new initiatives. Support clinical strategy and contribute scientific information to product development. Ensure scientific and clinical accuracy of product claims. Manage individual and complex clinical projects. Resolve customer complaints through clinical investigation. Support innovation, clinical testing, product development, and post-market surveillance. Should Have: Familiarity with GCP/GLP and ISO regulations. Understanding of product troubleshooting related to clinical results. Ability to collaborate with R&D on new testing methodologies. Experience with human blood specimen collection products. Skills: Strong working knowledge of clinical laboratory science. Strong communication skills. Strong computer skills. Project planning and budget management skills. Qualification And Education: BS/BA/MA in Clinical Laboratory Science, Medical Technology, Biology, Life Sciences, or a related field. MT/MLT CLS (ASCP) or equivalent experience in a research environment.

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