Trilab

Key Responsibilities

• Provide technical consultation for molecular diagnostic testing, including PCR, RT-PCR, NAAT, and other molecular platforms
• Review, approve, and oversee test validations, standard operating procedures (SOPs), quality control, and quality assurance processes
• Ensure compliance with CLIA, COLA, CAP, and all applicable federal, state, and local laboratory regulations
• Assist with laboratory inspections, audits, proficiency testing, and regulatory documentation
• Review and approve test reports, workflows, validation summaries, and technical documentation as required
• Provide guidance on assay development, verification, validation, and implementation of new tests
• Support troubleshooting of molecular instruments, automation systems, and testing processes
• Collaborate with the Laboratory Director, Medical Director, and leadership on regulatory, technical, and operational matters
• Be available for consultation as required to maintain compliance for high-complexity testing under CLIA regulations
• Maintain appropriate documentation to support role as Technical Consultant / General Laboratory Supervisor / Technical Supervisor, as applicable under CLIA/CAP requirements
• Participate in quality management activities, including corrective actions, competency review, and performance monitoring
• Onsite presence required a minimum of one (1) day per week, and additional onsite availability during validations, inspections, audits, or other key regulatory activities

Platforms Used

The consultant will provide technical oversight and support for the following laboratory platforms and automation systems:

• ThermoFisher QuantStudio 12K Flex
• ThermoFisher QuantStudio 5
• MSGI Liquid Handler Automation System
• MSGI Decapper Automation System
• KingFisher Extraction System
• Integra Automated Pipetting System

Minimum Qualifications

• Master’s degree in Molecular Biology, Medical Laboratory Science, Clinical Laboratory Science, Microbiology, or related scientific field
• Prior experience in a CLIA-certified high-complexity laboratory
• Strong knowledge of CLIA, COLA, CAP, and other applicable laboratory regulatory standards
• Experience with molecular testing methods including PCR, RT-PCR, NAAT, sequencing, or equivalent technologies
• Experience reviewing and approving validations, SOPs, quality systems, and technical procedures
• Ability to serve in a Technical Consultant, Technical Supervisor, or General Laboratory Supervisor capacity as defined under CLIA/CAP regulations
• Strong documentation, regulatory compliance, and inspection-readiness skills
• Ability to work in a part-time consultant role with onsite presence as required