Clinical Assay Specialist & CLIA Technical Supervisor

Labcorp is a global leader in laboratory services providing the insights and answers that help healthcare providers patients researchers pharmaceutical companies and health systems make confident decisions and improve outcomes. Through our unparalleled science data technology and laboratory network we advance diagnostics accelerate innovation and help address some of the worlds most important health challenges. As we shape the future of healthcare we are leveraging advanced technologies intelligent digital solutions and data-driven innovation across our operations to enhance how work gets done and deliver greater value to customers and patients. With our global scale and deep expertise youll have the opportunity to do meaningful work grow your career and make a real impact on peoples health around the world. Together were improving health and improving lives.

Labcorp is a global leader in diagnostic testing and drug development solutions helping healthcare providers researchers and patients make informed decisions that advance care. Join us in our mission to improve health and improve lives.

Labcorp is seeking a Clinical Assay Specialist & Technical Supervisor (CLIA) to join our team at 100 Perimeter Park Drive Morrisville NC.

Work Schedule

• Monday Friday 8am 5pm EST. Weekend work may be required.

Job 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.
• Partners with cross-functional teams 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.

Minimum Qualifications

U.S. Education Requirements:

The incumbent must qualify as a CLIA high complexity Technical Supervisor (42 CFR 493.1449) and General Supervisor (42 CFR 493.1461) and must meet applicable CAP and New York State Department of Health (NYSDOH) Clinical Laboratory Evaluation Program (CLEP) personnel requirements for these roles.

Technical Supervisor (high complexity) - must meet one of the following:

• An earned bachelors 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.
• An earned masters 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; OR
• An earned 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; OR

New York State (NYSDOH CLEP):

• Meet all NYSDOH CLEP qualification requirements applicable to the Technical Supervisor and supervisory role for the relevant category or categories of service as determined by NYSDOH. New York requirements may be more stringent than federal CLIA and final acceptance of an individual is subject to NYSDOH review.
• For testing samples originating in New York on-site supervision is always required such testing is performed.

Work Experience Required:

• 4 or more years experience with firsthand high complexity testing across one or more relevant platforms (e.g. IHC PCR/qPCR NGS immunoassay).
• 2 or more years experience supervising training or mentoring laboratory staff in a clinical setting preferred (to support supervisory growth of the role).

Preferred Qualifications

• Current ASCP (or equivalent) certification; ASCP Specialist in Molecular Biology (SM/MB)

Additional Job Standards

• Direct 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 of the laboratorys 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.
• 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.

• May work with potentially hazardous/biohazardous materials clinical or laboratory environment with exposure to biohazard materials.
• 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) always in laboratory areas.

About Labcorp

At Labcorp we are a global leader of innovative and comprehensive laboratory services that help doctors hospitals pharmaceutical companies researchers and patients make clear and confident decisions.

Through our unparalleled diagnostics and drug development laboratory capabilities our 70000 employees combine innovative innovation science and technology to solve some of todays biggest health challenges accelerate life-changing healthcare breakthroughs and impact lives around the world.

Here you are empowered to own your career journey and create a personalized development plan with the support of your team.

Benefits:Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical Dental Vision Life STD/LTD 401(k) Paid Time Off (PTO) or Flexible Time Off (FTO) Tuition Reimbursement and Employee Stock Purchase regularly scheduled to work less than 20 hours Casual Intern and Temporary employees are only eligible to participate in the 401(k) more detailed information pleaseclick here.

Labcorp is proud to be an Equal Opportunity Employer:

Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race religion color national origin sex (including pregnancy childbirth or related medical conditions) family or parental status marital civil union or domestic partnership status sexual orientation gender identity gender expression personal appearance age veteran status disability genetic information or any other legally protected characteristic. Additionally all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.

We encourage all to apply

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