Senior QA Lead, Laboratory Compliance & Audits

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

Benefits offered by this job

Comprehensive medical coverage

Dental and vision options

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins is seeking a Laboratory Quality Assurance (QA) Coordinator to ensure our quality system is well-documented, traceable, and compliant across federal, state, and local regulations. This role emphasizes regulatory readiness, audits, and document control within a fast-paced lab environment.

The successful candidate will oversee QMS, CAPA implementations, training, and risk management while coordinating with cross-functional teams to maintain quality records and supplier qualification

Qualifications

• Bachelor's degree in chemical, physical, biological science, or MLS/MT from an accredited institution.
• 5-7 years of experience in a clinical or analytical laboratory with QA/QC experience.
• Strong knowledge of ISO, CLIA, CAP and related regulations.
• Excellent attention to detail, organizational, communication, and data interpretation skills.

Responsibilities

• Develops, implements, and maintains the quality management system (QMS), policies and procedures.
• Ensure ongoing regulatory compliance with CAP, CLIA, ISO 15189, GxP, FDA.
• Coordinate internal and external audits/inspections and manage CAPAs.
• Maintain documentation and records; oversee nonconformances and deviations.
• Log change requests and ensure proper approval workflows and evidence.
• Develop and deliver staff training on quality standards and procedures.
• Assist in root-cause analysis for incidents and implement corrective actions.
• Facilitate QA meetings and coordinate with other departments.
• Manage Approved Supplier List (ASL) qualification and documentation.

Skills

Attention to detail

Analytical thinking

Problem solving

Communication skills

LIMS proficiency

Microsoft Office

Education

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

Tools

LIMS

Job description

Eurofins is seeking a Laboratory Quality Assurance (QA) Coordinator to ensure our quality system is well-documented, traceable, and compliant across federal, state, and local regulations. This role emphasizes regulatory readiness, audits, and document control within a fast-paced lab environment.

The successful candidate will oversee QMS, CAPA implementations, training, and risk management while coordinating with cross-functional teams to maintain quality records and supplier qualification