Clinical Assay Specialist & CLIA Technical Supervisor

Labcorp is a global leader in laboratory services, providing insights and answers that help healthcare providers, patients, researchers, pharmaceutical companies, and health systems make confident decisions and improve outcomes. Through unparalleled science, data, technology, and a laboratory network, we advance diagnostics, accelerate innovation, and address critical health challenges. This role offers the opportunity to do meaningful work, grow your career, and make a real impact on people’s health worldwide.

About the role

Labcorp is seeking a Clinical Assay Specialist & Technical Supervisor (CLIA) to join our team in Morrisville, NC. This position provides technical and scientific oversight for CLIA laboratory testing, ensuring compliance with regulatory and quality standards while supervising testing personnel and supporting high-complexity testing operations.

Schedule

Monday – Friday, 8:00 AM – 5:00 PM EST. Weekend work may be required.

Responsibilities

• Provide technical and scientific oversight for CLIA laboratory testing, ensuring compliance with regulatory and quality standards.
• Supervise testing personnel, including training, competency assessments, and day-to-day support for high-complexity testing.
• Lead assay transfers, verifications, and validation activities to support clinical laboratory operations.
• Establish, monitor, and improve quality control processes to ensure accurate and reliable test results.
• Troubleshoot technical and operational issues, implement corrective actions, and ensure testing systems meet performance requirements.
• Coordinate proficiency testing programs and support laboratory readiness for CAP, CLIA, NYSDOH, and other regulatory inspections.
• Partner with cross-functional teams to drive continuous improvement initiatives, workflow optimization, and operational efficiency.
• Support general laboratory operations, organization, and maintenance activities.
• Execute development and validation studies for Companion Diagnostic (CDx) programs under the direction of project leads.
• Provide direct technical support for CDx development activities, including sample processing, instrumentation, data generation, and troubleshooting.
• Contribute to the preparation and review of SOPs, validation protocols, reports, and technical documentation.

Requirements

• Must qualify as a CLIA high-complexity Technical Supervisor (42 CFR 493.1449) and General Supervisor (42 CFR 493.1461), meeting applicable CAP and New York State Department of Health (NYSDOH) Clinical Laboratory Evaluation Program (CLEP) personnel requirements.
• Technical Supervisor (high complexity) qualifications (must meet one of the following):
  • Bachelor’s degree in chemical, physical, or biological science, or medical technology, from an accredited institution and at least 4 years of experience in high-complexity testing in an acceptable laboratory.
  • Master’s degree in a chemical, physical, biological, or clinical laboratory science, or medical technology, from an accredited institution and at least 2 years of experience in high-complexity testing in an acceptable laboratory.
  • Doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution and at least 1 year of experience in high-complexity testing in an acceptable laboratory.
• For testing samples originating in New York, on-site supervision is required when such testing is performed.
• 4+ years of experience with firsthand high-complexity testing across one or more relevant platforms (e.g., IHC, PCR/qPCR, NGS, immunoassay).
• 2+ years of experience supervising, training, or mentoring laboratory staff in a clinical setting (preferred).

Preferred Qualifications

• Current ASCP (or equivalent) certification; ASCP Specialist in Molecular Biology (SM/MB).
• Experience establishing, activating, or accrediting a CLIA laboratory, or bringing a laboratory through CAP accreditation and/or New York State (NYSDOH CLEP) approval.
• Experience transferring and validating laboratory-developed tests (LDTs) or companion diagnostic assays from an R&D or development environment into a CLIA/clinical laboratory.
• Companion diagnostics (CDx) or IVD development experience, ideally supporting pharmaceutical clinical trials.
• Experience authoring and implementing SOPs, quality systems, and QC programs.
• Hands-on experience across one or more laboratory platforms: IHC, PCR/qPCR, NGS, and/or immunoassay (MSD-ECL).
• Familiarity operating in a regulated device or clinical-study environment (e.g., ISO 15189, IVDR, 21 CFR Part 11, GCP/ICH E6, ISO 20916).
• Theoretical and practical knowledge of analytical instrumentation.
• Knowledge of preclinical/clinical assays and companion diagnostics (CDx) development.
• Strong working knowledge of CLIA, CAP, and relevant state regulations.
• Proficiency with Laboratory Information Systems (LIS) and Microsoft Office.

Skills

• Excellent problem-solving and critical-thinking skills; ability to multitask and manage priorities in a demanding environment.
• Strong written and verbal communication skills; skilled in time management, planning, and delivering presentations.
• Must be able to see and distinguish colors.
• Must have command of the English language, both oral and written.
• Must be able to use hands to finger, handle, or touch objects, tools, or controls, including a keyboard, for up to 12 hours per day.
• Must be able to stand, walk, and/or bend for up to 12 hours per day and perform repetitive tasks; occasionally lifting up to 40 lbs.
• Mandatory use of personal protective equipment (lab coats, gloves, safety glasses) in laboratory areas.
• May work with potentially hazardous/biohazardous materials in a clinical or laboratory environment.

Benefits

Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits, including:

• Medical, dental, and vision coverage.
• Life, short-term disability (STD), and long-term disability (LTD) insurance.
• 401(k) retirement plan.
• Paid Time Off (PTO) or Flexible Time Off (FTO).
• Tuition reimbursement.
• Employee Stock Purchase Plan.

Employees scheduled to work less than 20 hours per week, casual, intern, and temporary employees are eligible to participate in the 401(k) plan only.