QA Coordinator – Lab Compliance & Audit Lead

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

Benefits offered by this job

Medical coverage

Dental and vision options

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA Clinical Diagnostics seeks a Laboratory Quality Assurance Coordinator to safeguard regulatory readiness and drive continuous quality improvements across labs. You will manage QMS documentation, audits, CAPAs, and staff training in a fast-paced setting.

Responsibilities include coordinating inspections, maintaining records, and ensuring compliance with CLIA, CAP, ISO 15189, and FDA standards while supporting supplier qualification and change management processes.

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 quality assurance/quality control experience.
• Knowledge: Strong knowledge of ISO, CLIA, CAP and related regulations.
• Skills: Excellent attention to detail and organizational abilities.

Responsibilities

• Develops, implements, and maintains the laboratory's quality management system (QMS).
• Monitor and ensure compliance with accreditation and regulatory standards (CAP, CLIA, ISO, FDA).
• Coordinate internal and external audits/inspections; manage CAPAs and responses.
• Maintain documentation control and nonconformance tracking; ensure accurate quality records.
• Support change management: log requests, track approvals, ensure evidence for closure.
• Design and deliver staff training on quality standards and procedures.
• Assist in investigating non-conformances and root cause analysis; implement corrective actions.
• Schedule QA meetings and act as liaison between QA and other departments.
• Develop and maintain ASL supplier qualification, including re-qualification documentation.

Skills

Quality management

Regulatory knowledge

Documentation

Analytical thinking

Attention to detail

Communication skills

LIMS

MS Office

Education

Bachelor's degree in chemistry/biology/MLS/MT

Tools

LIMS

Microsoft Office

Job description

Eurofins USA Clinical Diagnostics seeks a Laboratory Quality Assurance Coordinator to safeguard regulatory readiness and drive continuous quality improvements across labs. You will manage QMS documentation, audits, CAPAs, and staff training in a fast-paced setting.

Responsibilities include coordinating inspections, maintaining records, and ensuring compliance with CLIA, CAP, ISO 15189, and FDA standards while supporting supplier qualification and change management processes.