Clinical Assay Specialist (CLIA)

The Clinical Assay Specialist is responsible for providing technical and scientific oversight of high-complexity CLIA laboratory testing, ensuring regulatory compliance and serving as General Supervisor. Key duties include assay validation, quality control management, and facilitating assay transfer activitiesleading proficiency testing and preparing the lab for regulatory inspections (CAP, CLIA, NYSDOH)supporting companion diagnostic development and validation studies Qualifications require a bachelor’s degree in a laboratory science plus 1+ year high-complexity testing experience or an associate’s degree with 2+ years experience , along with CLIA General Supervisor certification and 4+ years of hands-on testing experience across platforms (IHC, PCR/qPCR, NGS, immunoassay) Additional skills include supervisory experience, knowledge of CLIA, CAP, state regulations, proficiency with Laboratory Information Systems, and Microsoft Office Certifications such as ASCP or equivalent are preferred.