CLIA Laboratory Supervisor, Oncology

Responsibilities

• Serve as a designated CLIA General Supervisor for high-complexity testing in accordance with 42 CFR Part 493 and CAP accreditation standards.
• Provide day-to-day supervision of laboratory personnel, including CLSs and CLAs, during the pre-analytic, analytic, and post-analytic phases of testing.
• Act as the primary escalation point for technical, operational, and personnel issues during assigned shifts.
• Oversee staffing, scheduling, shift handoffs, and workload distribution to ensure operational continuity.
• Perform and oversee high-complexity molecular oncology assays, supporting diagnostic testing for patient care.
• Ensure proper instrument operation, calibration, maintenance, and troubleshooting.
• Review, interpret, and verify test results and quality control data.
• Identify, investigate, and resolve deviations that may impact test performance or result integrity.
• Ensure compliance with CLIA, CAP, state, and local regulatory requirements.
• Perform, review, and document quality control, corrective actions, and preventive maintenance.
• Participate in inspection readiness, audits, and regulatory responses.
• Lead or support SOP development, review, and biennial updates.
• Lead training, onboarding, and competency assessments for new and existing laboratory staff.
• Provide hands-on and theoretical training for new assays, processes, and instrumentation.
• Support process improvement initiatives, including assay validation, tech transfer, and troubleshooting.
• Partner cross-functionally with Quality, R&D, and Operations to drive continuous improvement.

Qualifications

• Active California Clinical Laboratory Scientist (CLS) license (or CGMBS/generalist license) meeting CLIA requirements for high-complexity testing.
• Bachelor’s degree in chemical, biological, physical, clinical laboratory science, or a related field.
• Minimum 4 years of clinical laboratory experience, including molecular and/or high-complexity testing.
• Mechanically inclined and demonstrated hands-on experience with molecular biology techniques (e.g., DNA extraction, PCR, automated liquid handlers).
• Strong working knowledge of LIMS, quality systems, and laboratory documentation.
• Proficiency with Google Docs, Excel, Word, and basic statistical analysis.
• Excellent attention to detail, organizational skills, and ability to perform under time-sensitive conditions.
• Strong written and verbal communication skills and a collaborative leadership style.