Laboratory QA & Compliance Lead

Eurofins PSS Ireland Ltd; Centennial, Northern (CO, KY); Hybrid; USD 85,000 - 105,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401(k) with company match

Paid vacation and holidays

Life and disability insurance

Training opportunities

Job summary

Eurofins USA Clinical Diagnostics is seeking a Laboratory Quality Assurance Coordinator to ensure the lab's quality system is well-documented, traceable, and compliant. You will focus on regulatory readiness documentation, inspections, and the procedural backbone of the QA program in a fast-paced environment.

Responsibilities include maintaining the QMS, coordinating audits, managing CAPAs, training staff, and liaising with other departments to keep records up-to-date and compliant with CLIA,

Qualifications

• Bachelor's degree in chemical, physical, or biological sciences (MLS/MT acceptable).
• 5–7 years in a clinical or analytical lab with QA/QC experience.
• Strong knowledge of ISO, CLIA, CAP and regulatory standards.

Responsibilities

• Develops and maintains the quality management system (QMS) and policies.
• Monitors compliance with CAP, CLIA, ISO 15189, GxP, and FDA guidelines.
• Coordinates internal and external audits and tracks corrective actions.
• Oversees document control and nonconformance handling.
• Trains staff on quality procedures and ensures record accuracy.

Skills

Attention to detail

Analytical skills

Communication skills

LIMS proficiency

Microsoft Office

Team player

Education

Bachelor's degree in science

Tools

LIMS

Microsoft Office Suite

Job description

Eurofins USA Clinical Diagnostics is seeking a Laboratory Quality Assurance Coordinator to ensure the lab's quality system is well-documented, traceable, and compliant. You will focus on regulatory readiness documentation, inspections, and the procedural backbone of the QA program in a fast-paced environment.

Responsibilities include maintaining the QMS, coordinating audits, managing CAPAs, training staff, and liaising with other departments to keep records up-to-date and compliant with CLIA,