Clinical Lab Specialist

4 weeks ago

Franklin Lakes, United States Cynet Systems Full time

Job Description: Pay Range: $50.57hr - $53.57hr The Clinical Laboratory Scientist conducts and oversees complex scientific investigations within the clinical laboratory, ensuring high-quality results and compliance with regulatory standards. This role involves developing methodologies, performing validations, supporting product development, and maintaining scientific integrity across laboratory operations. Responsibilities: Provide input to and conduct scientific investigations of considerable scope and complexity. Explore, identify, and recommend solutions, concepts, and principles to improve laboratory operations. dapt methodologies as needed for areas related to the core clinical laboratory. Conduct clinical testing and maintain laboratory instrumentation, reagent systems, and inventory in alignment with business priorities. Implement and document Quality Assurance and Quality Control procedures for instrumentation and methodology. Perform instrument verification following CLSI guidelines and assist with documentation in compliance with GLP and GCP. Conduct Clinical Software Validations (CSV) and new instrument qualification/validation (IQ/OQ/PQ) according to clinical lab best practices. Stay current in Clinical Laboratory Science through ongoing education and literature review. Train new laboratory associates on workflow, techniques, and compliance requirements. Monitor laboratory trends to recommend and influence ongoing and future projects. Participate in the development of clinical strategies for Specimen Management products and contribute to product conceptualization and development. Ensure scientific integrity and clinical accuracy in all product-related claims and communications. Manage individual and complex multi-study clinical projects. Support customer complaint resolution through clinical investigations. Collaborate with R&D and GCD teams to guide innovation, clinical testing, manufacturing, and post-market surveillance activities. Skills: Strong working knowledge of clinical laboratory science. Excellent verbal and written communication skills. Understanding of GCP, GLP, and ISO regulations. Experience in Clinical Software Validation (CSV) and instrument qualification/validation (IQ/OQ/PQ). Phlebotomy skills are a plus. Experience with human blood specimen collection products. Troubleshooting skills related to clinical results. Strong computer, project planning, and budget management skills. bility to develop and implement new testing methodologies with R&D collaboration. Solid understanding of clinical laboratory testing, blood collection, urinalysis, POC, and LIS/LIMS systems. Qualification and Education: BS/BA/MA in Clinical Laboratory Science, Medical Technology, Biology, Life Sciences, or a related field (required). MT/MLT CLS (ASCP) certification or equivalent research experience. Minimum of 5 years of experience in a clinical laboratory environment.

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