QA Compliance Lead: Audits, Documentation, and Regulation

Eurofins; 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 is seeking a Laboratory Quality Assurance Coordinator to ensure the quality system is well-documented, traceable, and compliant. The role focuses on regulatory readiness documentation and inspection support, tracking, organizing, and executing the quality program across laboratories.

You will develop policies, conduct audits, maintain records, train staff, and drive improvements while ensuring compliance with CLIA, CAP, ISO, and FDA standards in a fast-paced environment.

Qualifications

• Bachelor's degree in a chemical, physical, biological science, or MLS/MT.
• 5–7 years in a clinical or analytical lab with QA/QC experience.
• Strong knowledge of ISO, CLIA, CAP and related regulations.
• Excellent attention to detail and organizational skills.
• Proficient with LIMS and MS Office.

Responsibilities

• Quality Management System oversight: develop, implement, and maintain the lab's QMS (Quality Manual, policies, procedures).
• Regulatory Compliance: ensure ongoing CAP/CLIA/ISO and regulatory adherence.
• Audits and Inspections: coordinate audits, manage findings, implement CAPAs, prepare materials for inspections.
• Documentation and Record Control: manage documentation system, track nonconformances and deviations.
• Change Management: log change requests, track approvals and evidence for closure.
• Training and Education: train staff on quality standards and procedures.
• Event and Risk Management: investigate nonconformances, perform root-cause analysis, implement corrective actions.
• Communication: schedule QA meetings and liaise between QA and other departments.
• Supplier Qualification: manage ASL qualification and supplier-related documentation.

Skills

Attention to detail

Analytical thinking

Verbal and written communication

LIMS experience

MS Office proficiency

Education

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

Tools

LIMS

Microsoft Office

Job description

Eurofins is seeking a Laboratory Quality Assurance Coordinator to ensure the quality system is well-documented, traceable, and compliant. The role focuses on regulatory readiness documentation and inspection support, tracking, organizing, and executing the quality program across laboratories.

You will develop policies, conduct audits, maintain records, train staff, and drive improvements while ensuring compliance with CLIA, CAP, ISO, and FDA standards in a fast-paced environment.