Regulatory QA Leader — Lab Compliance & Audits

Eurofins; Centennial (CO); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

Medical coverage

Dental & Vision

401(k) match

Paid vacation

Job summary

Eurofins USA Clinical Diagnostics is seeking a Laboratory Quality Assurance Coordinator to ensure the quality system is compliant and well-documented. You will focus on regulatory readiness, inspections, and administering the laboratories’ quality backbone.

The role requires 5–7 years in a clinical or analytical lab QA environment, with strong knowledge of ISO, CLIA, CAP, and proficiency in LIMS/Microsoft Office. On-site position in Centennial, CO with comprehensive benefits.

Qualifications

• 5–7 years of experience in a clinical or analytical laboratory quality role.
• Strong knowledge of ISO, CLIA, CAP and related regulations.
• Excellent documentation, audit, and problem-solving skills.
• Proficient in QA/QC practices and regulatory inspection readiness.

Responsibilities

• Develops and maintains the laboratory's quality management system.
• Ensures ongoing regulatory compliance across standards (CAP, CLIA, ISO).
• Coordinates internal/external audits and CAPA processes.
• Manages documentation, records, and change control activities.
• Trains staff on quality procedures and regulatory expectations.
• Participates in risk assessment and incident investigations.

Skills

Attention to detail

Organisational skills

Analytical thinking

Communication skills

LIMS proficiency

MS Office

Education

Bachelor's degree in a chemical, physical, biological science or MLS/MT

Tools

LIMS

Microsoft Office

Job description

Eurofins USA Clinical Diagnostics is seeking a Laboratory Quality Assurance Coordinator to ensure the quality system is compliant and well-documented. You will focus on regulatory readiness, inspections, and administering the laboratories’ quality backbone.

The role requires 5–7 years in a clinical or analytical lab QA environment, with strong knowledge of ISO, CLIA, CAP, and proficiency in LIMS/Microsoft Office. On-site position in Centennial, CO with comprehensive benefits.