Quality Assurance Coordinator - Lab Compliance & CAPA

Eurofins Clinical Diagnostics; Fairfield (OH); On-site; USD 55,000 - 63,250; Full time

Benefits offered by this job

Medical/dental/vision

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

DNA Diagnostics Center, LLC (DDC) seeks a Quality Assurance Coordinator to support the administration, maintenance, and continuous improvement of the laboratory Quality Management System (QMS). This role will partner with the Laboratory Director and leadership to ensure compliance with applicable regulatory, accreditation, and internal quality requirements.

The QA Coordinator will manage MediaLab and related systems, control documents, training compliance, audits, CAPA, and quality metrics,

Qualifications

• Bachelor's degree in Biology, Business Management, or a related field required.
• Minimum of 2 years of experience 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 required.
• Experience using MediaLab, MasterControl, TrackWise, Qualtrax, or similar quality management systems preferred.
• Working knowledge of quality systems and quality assurance 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 laboratory accreditation and regulatory requirements such as CLIA, CAP, ISO, NATA, or similar standards preferred.
• Strong organizational skills and attention to detail with the ability to manage multiple priorities.
• Demonstrated analytical and problem-solving abilities.
• Strong written and verbal communication skills.
• Ability to analyze data and identify trends, risks, and opportunities for improvement.
• Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint.
• Ability to build collaborative working relationships across departments.
• Self-motivated with the ability to work independently while contributing effectively within a team.
• Strong judgment, professionalism, and discretion when handling sensitive information.

Responsibilities

• Coordinate day-to-day operation and maintenance of the laboratory Quality Management System (QMS).
• Serve as a primary administrator for MediaLab and related quality management platforms.
• Manage document control processes, including SOPs, forms, and quality records.
• Monitor training assignments and ensure compliance with training requirements.
• Support internal audits, inspections, and accreditation activities.
• Track, investigate, and document nonconformances, deviations, incidents, and CAPA.
• Coordinate CAPA activities and ensure timely completion.
• Assist with root cause analyses and continuous improvement initiatives.
• Collect, analyze, trend, and report laboratory quality metrics.
• Support regulatory compliance activities (CLIA, CAP, AABB, ISO, NATA).
• Assist in vendor quality documentation reviews and supplier qualification.
• Facilitate quality meetings and prepare reports for management review.
• Develop and deliver quality-related training and materials.
• Collaborate with operations and cross-functional teams to ensure standards.
• Support readiness for audits through monitoring and process reviews.
• Identify opportunities to streamline workflows and strengthen processes.
• Other duties as assigned.

Skills

Analytical skills

Problem solving

Communication skills

Collaboration

Organizational skills

Education

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

Tools

MediaLab

MasterControl

TrackWise

Qualtrax

Job description

DNA Diagnostics Center, LLC (DDC) seeks a Quality Assurance Coordinator to support the administration, maintenance, and continuous improvement of the laboratory Quality Management System (QMS). This role will partner with the Laboratory Director and leadership to ensure compliance with applicable regulatory, accreditation, and internal quality requirements.

The QA Coordinator will manage MediaLab and related systems, control documents, training compliance, audits, CAPA, and quality metrics,