Position SummaryWe are seeking a qualified and experienced Technical Supervisor for a CLIA-certified
High Complexity Laboratory. The Technical Supervisor will provide technical oversight of
laboratory testing, ensure compliance with CLIA, CAP and state regulatory
requirements, and support the implementation and maintenance of a robust Quality
Management System.
The ideal candidate will have extensive experience in molecular diagnostics (PCR-
Infectious disease), general chemistry, hematology and possess a strong understanding
of laboratory regulations, method validation, quality assurance, and personnel
competency.
Key Responsibilities- Perform all high-complexity laboratory testing, data review and reporting.
- Monitor quality control, proficiency testing, and quality assurance activities.
- Investigate testing discrepancies, QC failures, proficiency testing events, and
implement corrective actions.
- Ensure compliance with CLIA, CAP, state regulations.
- Review and approve validation and verification studies for new tests,
instruments, and methodologies.
- Develop, review, and approve laboratory SOPs, policies, and technical
procedures.
- Establish and monitor quality indicators and support continuous quality
improvement initiatives.
- Oversee personnel training, competency assessments, and continuing
education.
- Ensure preventive maintenance, calibration, and qualification of laboratory
equipment are performed and documented.
- Participate in internal audits, inspection readiness activities, and regulatory
inspections.
- Collaborate with the Laboratory Director, Clinical Consultant, and laboratory staff
to maintain high-quality laboratory operations.
- Provide technical consultation to laboratory personnel regarding testing
procedures, troubleshooting, and result interpretation.
Minimum QualificationsApplicants must meet CLIA (42 CFR 493.1449) requirements for a High Complexity
Technical Supervisor.
Preferred qualifications include:- Ph.D. or Master's degree in Chemical, Physical, Biological, or Clinical Laboratory
Science (Bachelor's degree with qualifying experience may be considered where
permitted under CLIA).
- Current ASCP or equivalent certification preferred.
- Minimum 3-4 years of experience supervising high-complexity laboratory testing
with PCR infectious disease testing.
- Experience in one or more of the following:
- Molecular Diagnostics (PCR)
- Clinical Chemistry
- Microbiology
- Hematology
- Strong knowledge of CLIA, CAP accreditation requirements, and quality
management systems.
- Excellent written and verbal communication skills.
- Experience with laboratory information systems (LIS) and electronic quality
management systems is preferred.
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