Clinical Assay Specialist (CLIA)
Labcorp
Labcorp seeks a Clinical Assay Specialist to provide technical and scientific oversight of CLIA laboratory testing, ensure regulatory compliance, and serve as General Supervisor for high-complexity testing operations. The role includes assay validation, quality control management, and support for companion diagnostic development.
Responsibilities
- Provide technical oversight and ensure compliance with regulatory and quality standards for CLIA laboratory testing
- Serve as General Supervisor and Technical Supervisor, overseeing testing, training, competency assessments, and day-to-day high-complexity operations
- Lead assay transfer and validation activities; establish and monitor quality control processes for accurate results
- Coordinate proficiency testing programs and prepare laboratory for regulatory inspections (CAP, CLIA, NYSDOH)
- Execute companion diagnostic development and validation studies; support CDx technical activities and documentation
Requirements
- Bachelor's degree in chemical, biological, clinical, or medical laboratory science plus 1+ year high-complexity testing experience; or Associate's degree plus 2+ years experience
- CLIA General Supervisor (high-complexity) qualification per 42 CFR 493.1461 and applicable state requirements
- 4+ years hands-on high-complexity testing experience across platforms (IHC, PCR/qPCR, NGS, immunoassay)
- 2+ years supervising, training, or mentoring laboratory staff in clinical setting
- Strong knowledge of CLIA, CAP, and state laboratory regulations
- Proficiency with Laboratory Information Systems and Microsoft Office
- ASCP certification or equivalent; ASCP Specialist in Molecular Biology preferred
Vacancy posted 5 days ago
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