Lab Quality & Compliance Coordinator

Eurofins Clinical Diagnostics; Philadelphia (Philadelphia County); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA Clinical Diagnostics is seeking a Laboratory Quality Assurance (QA) Coordinator to ensure the lab’s quality system is well-documented, traceable, and compliant with CLIA, CAP, ISO and FDA requirements.

You will develop policies, conduct audits, manage documentation, train staff, and support regulatory inspections, driving continuous quality improvements across the organization in a fast-paced environment.

Qualifications

• Education: Bachelor’s degree in a chemical, physical, biological science, or MLS/MT from an accredited institution.
• Experience: 5–7 years in a clinical or analytical laboratory with QA/QC experience.
• Knowledge: Strong knowledge of quality systems (ISO, CLIA, CAP) and regulations.
• Skills: Attention to detail, organization, analysis, communication, data interpretation.

Responsibilities

• Develops, implements, and maintains the laboratory's quality management system, including manuals and procedures.
• Ensure regulatory compliance with CAP, CLIA, ISO 15189, GxP, FDA.
• Coordinate and participate in audits/inspections; manage CAPAs and responses.
• Oversee documentation control, nonconformances, deviations, and incident reports.
• Support change control, evidence collection, and timely closure of actions.
• Train staff on quality procedures and new processes; promote a quality culture.
• Communicate deadlines and updates between QA and other departments.
• Manage supplier qualification and ASL documentation and related actions.

Skills

Attention to detail

Organizational skills

Analytical skills

Problem-solving

Communication skills

LIMS proficiency

Microsoft Office

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 (QA) Coordinator to ensure the lab’s quality system is well-documented, traceable, and compliant with CLIA, CAP, ISO and FDA requirements.

You will develop policies, conduct audits, manage documentation, train staff, and support regulatory inspections, driving continuous quality improvements across the organization in a fast-paced environment.