Clinical Lab QA Specialist — QC & Compliance Expert

HepQuant, LLC; Denver (CO); On-site; USD 80,000 - 95,000; Full time

Job summary

HepQuant, LLC, a Denver-based clinical laboratory, seeks a detail-oriented Laboratory Quality Assurance Specialist to join our regulated operations team in Aurora/Denver. This role ensures data quality, regulatory compliance, and robust QA processes in a CLIA/CAP laboratory setting.

You will monitor QC, supervise data review against SOPs, support CAPA, investigate deviations, and aid continuous improvement to maintain high standards of accuracy and reliability in our liver diagnostics testing

Qualifications

• Bachelor’s or Associate’s degree in Medical Laboratory Science, Biology, Chemistry, Biotechnology, Biochemistry, Clinical Laboratory Science, or related scientific discipline, or equivalent relevant laboratory experience.
• 2 years of experience in a clinical, diagnostic, quality control, biotechnology, or other regulated laboratory environment, including ISO 15189 familiarity.
• Experience with SOP-driven laboratory processes and quality systems.
• Strong attention to detail with excellent documentation and organizational skills.

Responsibilities

• Quality Control testing and assay performance monitoring across QC results, SOPs, and regulatory requirements.
• Support sample accessioning, processing, tracking, and testing workflows in a CLIA/CAP lab environment.
• Maintain audit-ready documentation, including QC records, instrument logs, training records, and testing reports.

Skills

Detail-oriented

Documentation

LIS/LIMS

Regulatory compliance

Quality systems

Education

Bachelor’s or Associate’s degree in Medical Laboratory Science or related

Tools

MS Office

Job description

HepQuant, LLC, a Denver-based clinical laboratory, seeks a detail-oriented Laboratory Quality Assurance Specialist to join our regulated operations team in Aurora/Denver. This role ensures data quality, regulatory compliance, and robust QA processes in a CLIA/CAP laboratory setting.

You will monitor QC, supervise data review against SOPs, support CAPA, investigate deviations, and aid continuous improvement to maintain high standards of accuracy and reliability in our liver diagnostics testing