A Clinical Laboratory Manager manages laboratory research and procedures for numerous fields such as health, industry, or other natural sciences. Commonly oversees R&D, diagnostic or treatment to allow patients to receive better health outcomes. Responsible for regulatory, health and safety operations during laboratory activities.
Molecular Laboratory Supervisor OspriBio Path - Tyler Tyler, TX Job Details Full-time From $72,000 a year 1 day ago Benefits Health insurance Dental insurance Vision insurance Qualifications Biology Diagnostic result interpretation OSHA Team supervision CAP guidelines Contamination control Molecular diagnostic equipment Master's degree Supervising experience Laboratory regulatory affairs CLIA regulations Regulatory readiness in healthcare Managing testing technician teams Productivity software Clinical quality assurance standards Laboratory information systems (LIS) Associate's degree Molecular biology Molecular analysis Full Job Description
POSITION SUMMARY
Oversees day-to-day operations of a high-complexity PCR laboratory, supervises testing personnel, performs real-time PCR on patient specimens, and maintains continuous inspection readiness under CLIA, CAP, and COLA standards.
RESPONSIBILITIES
Fulfill General Supervisor duties in a high-complexity molecular PCR laboratory per 42 CFR 493.1463. Provide direct, on-site supervision of testing personnel during all hours of testing. Process patient specimens using real-time
PCR:
nucleic acid extraction, amplification, and result interpretation. Review and release preliminary and final results; investigate and resolve discrepant or invalid results. Perform and document instrument maintenance, calibration, and function checks per manufacturer specifications. Prepare and QC reagents; maintain reagent and lot-to-lot verification records. Monitor QA/QC, proficiency testing, and competency assessments; maintain inspection readiness at all times. Coordinate daily with Laboratory Director and Technical Supervisor on test performance, validation, and corrective actions. Train, mentor, and evaluate testing personnel; document competency per CLIA requirements. Enforce OSHA, HIPAA, and all laboratory safety practices; report unsafe conditions promptly.
REQUIRED SKILLS
Working knowledge of CLIA, CAP, and COLA requirements for high-complexity testing. Comprehensive understanding of PCR workflow, molecular diagnostics, and contamination control. Proficient interpreting amplification curves, Ct values, and controls for qualitative and quantitative PCR assays. Microsoft Office proficiency;
LIS/LIMS
experience required. Strong interpersonal and communication skills with demonstrated ability to supervise a team.
CLIA QUALIFICATIONS - REQUIRED MINIMUM
(42 CFR 493.1461) Candidate must meet one of the following to serve as General Supervisor of high-complexity testing: Bachelor's degree in a chemical, physical, biological, or clinical laboratory science, or medical technology, from an accredited institution, AND at least 1 year of laboratory training or experience in high-complexity molecular/PCR testing. OR Associate degree in a chemical, physical, or biological science, or medical laboratory technology, from an accredited institution, AND at least 2 years of laboratory training or experience in high-complexity molecular/PCR testing. OR currently qualified under 42 CFR 493.1443 as Laboratory Director or 42 CFR 493.1449 as Technical Supervisor for high-complexity testing.
CLIA QUALIFICATIONS - PREFERRED / OPTIONAL
Master's or doctoral degree in molecular biology, biochemistry, microbiology, or related life science.
Board certification:
ASCP MB (Technologist in Molecular Biology), MLS, or equivalent. 3+ years hands-on experience with real-time PCR platforms (QuantStudio, CFX, LightCycler). Prior experience leading a laboratory through CAP, COLA, or state inspections. Experience validating molecular assays (sensitivity, specificity, precision, LOD). Supervisory experience managing 2+ testing personnel.
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
Possible exposure to bloodborne pathogens and hazardous chemicals. Ability to climb stairs, lift 35 lbs, sit or stand for long periods, walk/bend. Visual and auditory acuity with good eye/hand coordination. Must demonstrate competency for all required diagnostic tests within 3 months of hire.
DIRECT REPORTING
Reports to the Technical Supervisor and Laboratory Director.
Job Type:
Full-time Pay:
From $72,000.00 per year
Benefits:
Dental insurance Health insurance Vision insurance
