Laboratory QA Coordinator - Compliance & Audits

RXinsider LTD.; Philadelphia (Philadelphia County); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA Clinical Diagnostics is seeking a Laboratory Quality Assurance Coordinator to ensure the quality system is well-documented, traceable, and compliant with CLIA, CAP, ISO, and FDA requirements. The role focuses on regulatory readiness documentation and inspection support, driving continuous quality improvements across laboratories.

You will develop policies, conduct audits, train staff, and manage documentation while coordinating with cross-functional teams to ensure timely and

Qualifications

• Bachelor's degree in chemical, physical, biological science, or MLS/MT.
• Minimum 5–7 years in a clinical or analytical lab with QA/QC experience.
• Solid knowledge of ISO, CLIA, CAP and related regulations.

Responsibilities

• Develop, implement and maintain a comprehensive QMS, including the Quality Manual, policies and procedures.
• Monitor and ensure ongoing compliance with CAP, CLIA, ISO 15189 and GxP standards.
• Coordinate internal and external audits and inspections; manage CAPAs and corrective actions.
• Maintain documentation control; track nonconformances, deviations and incident reports.
• Log change requests; monitor approvals and ensure evidence is complete before closure.
• Develop and deliver staff training on quality standards and procedures.

Skills

Attention to detail

Analytical thinking

Communication skills

LIMS proficiency

MS Office proficiency

Independent and collaborative work

Education

Bachelor's degree in 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 well-documented, traceable, and compliant with CLIA, CAP, ISO, and FDA requirements. The role focuses on regulatory readiness documentation and inspection support, driving continuous quality improvements across laboratories.

You will develop policies, conduct audits, train staff, and manage documentation while coordinating with cross-functional teams to ensure timely and