Laboratory QA & Compliance Coordinator

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

Benefits offered by this job

Medical, dental, and vision benefits

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 Coordinator to lead the quality management system, ensure regulatory readiness, and support inspections. The role emphasizes documentation, audits, CAPAs, and staff training in a fast-paced clinical lab environment.

Responsibilities include oversight of QMS, change management, training, and supplier qualification while ensuring compliance with CAP, CLIA, ISO, and FDA guidelines.

Qualifications

• Bachelor's degree in a chemical, physical, biological science, or MLS/MT.
• Minimum 5–7 years in a clinical or analytical lab with QA/QC experience.
• Strong knowledge of quality management systems (ISO/CLIA/CAP) and regulations.
• Proficiency with LIMS and MS Office; excellent communication skills.

Responsibilities

• Develop and maintain the laboratory's QMS, policies, and procedures.
• Ensure regulatory compliance with CAP, CLIA, ISO, and FDA standards.
• Coordinate internal and external audits, manage CAPAs and corrective actions.
• Oversee document control and records, track nonconformances and deviations.
• Log change requests, manage approval workflows, and ensure documentation before closure.
• Design and deliver training on quality procedures to staff.
• Investigate non-conformances and incidents; perform root-cause analysis.
• Schedule QA meetings, capture minutes, and liaise with other departments.
• Oversee Supplier Qualification and ASL documentation.

Skills

Attention to detail

Organizational skills

Analytical thinking

Problem solving

Communication

Data interpretation

Statistical analysis

Independent work

Team collaboration

Education

Bachelor's degree in a chemical/physical/biological science

Tools

LIMS

Microsoft Office Suite

Job description

Eurofins USA Clinical Diagnostics is seeking a Laboratory Quality Assurance Coordinator to lead the quality management system, ensure regulatory readiness, and support inspections. The role emphasizes documentation, audits, CAPAs, and staff training in a fast-paced clinical lab environment.

Responsibilities include oversight of QMS, change management, training, and supplier qualification while ensuring compliance with CAP, CLIA, ISO, and FDA guidelines.