Quality Assurance Lead: Lab Compliance & Audits

Eurofins Clinical Diagnostics; Centennial (WY); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA Clinical Diagnostics is seeking a Laboratory Quality Assurance (QA) Coordinator to maintain the quality system, ensure regulatory readiness, and support inspections. The role emphasizes documentation, audits, CAPAs, and training to sustain laboratory compliance.

The QA Coordinator develops policies, conducts audits, maintains records, and collaborates across departments to uphold CLIA, CAP, ISO, and FDA requirements in a fast-paced environment.

Qualifications

• Bachelor’s degree in a chemical/physical/biological science or MLS/MT from an accredited institution.
• 5–7 years in a clinical or analytical lab with QA/QC experience.
• Strong knowledge of ISO, CLIA, CAP and related regulations.

Responsibilities

• Develop, implement, and maintain the laboratory's quality management system and policies.
• Coordinate internal/external audits and inspections; track CAPAs and corrective actions.
• Manage documentation control, nonconformances, deviations, and incident reports.
• Support change management, training, and supplier qualification activities.

Skills

Attention to detail

Organizational skills

Analytical thinking

Effective communication

Team collaboration

Education

Bachelor's degree in chemical/physical/biological science

MLS/MT certification (preferred)

Tools

LIMS

Microsoft Office

Job description

Eurofins USA Clinical Diagnostics is seeking a Laboratory Quality Assurance (QA) Coordinator to maintain the quality system, ensure regulatory readiness, and support inspections. The role emphasizes documentation, audits, CAPAs, and training to sustain laboratory compliance.

The QA Coordinator develops policies, conducts audits, maintains records, and collaborates across departments to uphold CLIA, CAP, ISO, and FDA requirements in a fast-paced environment.