Lab QA Coordinator: CAPA & Audits

Eurofins Clinical Diagnostics; Fairfield (CA); On-site; USD 50,000 - 61,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) with company match

Paid vacation and holidays

Life and disability insurance

Job summary

Eurofins USA Clinical Diagnostics is seeking a Quality Assurance Coordinator to support the administration, maintenance, and continuous improvement of the laboratory Quality Management System (QMS). This role will partner closely with the Laboratory Director and leadership to ensure compliance with applicable regulatory, accreditation, and internal quality requirements.

The QA Coordinator will serve as a key administrator of the laboratory's quality processes through MediaLab and related

Qualifications

• Bachelor's degree in Biology, Business Management, or related field.
• Minimum of 2 years in quality assurance, quality control, laboratory operations, or a regulated healthcare/life sciences environment.
• Experience supporting laboratory quality systems, audits, accreditation, or regulatory compliance activities.
• Experience using MediaLab, MasterControl, TrackWise, Qualtrax, or similar quality management systems preferred.
• Working knowledge of quality systems and QA principles within a laboratory, healthcare, diagnostic, manufacturing, or regulated environment.
• Familiarity with document control, CAPA, audit management, training compliance, and continuous improvement processes.
• Knowledge of CLIA, CAP, AABB, ISO, NATA, or similar standards preferred.
• Strong organizational, analytical, and communication skills.

Responsibilities

• Coordinate day-to-day operation and maintenance of the laboratory Quality Management System (QMS).
• Administer MediaLab and related quality management platforms.
• Manage document control processes, including SOPs, forms, and quality records revisions.
• Monitor training assignments within MediaLab and ensure compliance.
• Support internal audits, inspections, and accreditation activities with proper documentation.
• Track, investigate, and document nonconformances, CAPA, and quality events.
• Assist with root cause analyses and continuous improvement initiatives.
• Collect, analyze, trend, and report quality metrics and KPIs.
• Support regulatory compliance activities associated with CLIA, CAP, AABB, ISO, NATA, or similar standards.
• Assist in vendor quality documentation reviews and supplier qualification as assigned.
• Facilitate quality meetings and prepare management-review reports.

Skills

Quality assurance

Regulatory compliance

Document control

Audits

Data analysis

Communication

Education

Bachelor's degree in Biology/Business Management or related field

Tools

MediaLab

MasterControl

TrackWise

Qualtrax

Job description

Eurofins USA Clinical Diagnostics is seeking a Quality Assurance Coordinator to support the administration, maintenance, and continuous improvement of the laboratory Quality Management System (QMS). This role will partner closely with the Laboratory Director and leadership to ensure compliance with applicable regulatory, accreditation, and internal quality requirements.

The QA Coordinator will serve as a key administrator of the laboratory's quality processes through MediaLab and related