Molecular Diagnostics Consultant & Lab Compliance Lead

Trilab, LLC; Elmhurst (IL); Hybrid; USD 60,000 - 80,000; Part time

Job summary

A leading diagnostic testing company located in Elmhurst, Illinois, is seeking a Technical Consultant to oversee molecular diagnostic testing and ensure compliance with federal and state regulations. The role requires a Master’s degree in a relevant scientific field and experience in a CLIA-certified laboratory. Responsibilities include reviewing test validations and regulatory documentation, providing technical guidance, and being onsite a minimum of one day per week for key activities. Strong knowledge of molecular testing methods is essential.

Qualifications

• Master’s degree in Molecular Biology, Medical Laboratory Science, or related scientific field.
• Prior experience in a CLIA-certified high-complexity laboratory.
• Strong knowledge of CLIA, COLA, CAP, and laboratory regulations.

Responsibilities

• Provide technical consultation for molecular diagnostic testing.
• Review, approve, and oversee test validations and quality processes.
• Ensure compliance with CLIA, COLA, CAP, and applicable regulations.

Skills

Knowledge of PCR and molecular testing methods

Regulatory compliance expertise

Strong documentation skills

Quality management activities

Education

Master’s degree in Molecular Biology or related field

Tools

ThermoFisher QuantStudio 12K Flex

ThermoFisher QuantStudio 5

MSGI Liquid Handler Automation System

KingFisher Extraction System

Job description

A leading diagnostic testing company located in Elmhurst, Illinois, is seeking a Technical Consultant to oversee molecular diagnostic testing and ensure compliance with federal and state regulations. The role requires a Master’s degree in a relevant scientific field and experience in a CLIA-certified laboratory. Responsibilities include reviewing test validations and regulatory documentation, providing technical guidance, and being onsite a minimum of one day per week for key activities. Strong knowledge of molecular testing methods is essential.