Quality Assurance Coordinator

Job Description

Candidates must be located within a commutable distance of 1 DDC Way, Fairfield, OH 45014

DDC 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 laboratory leadership team to ensure compliance with applicable regulatory, accreditation, and internal quality requirements.

The Quality Assurance Coordinator will serve as a key administrator of the laboratory's quality processes through MediaLab and related systems, supporting document control, training compliance, audits, corrective and preventive actions (CAPA), quality metrics, and continuous improvement initiatives. This position is ideal for an associate-level quality professional with laboratory exposure looking to expand their impact in a regulated diagnostic laboratory environment.

_ Essential Duties & Responsibilities _
• Coordinate day-to-day operation and maintenance of the laboratory Quality Management System (QMS).
• Serve as a primary administrator and subject matter resource for MediaLab and related quality management platforms.
• Manage document control processes, including creation, review, approval routing, revision tracking, and archival of standard operating procedures (SOPs), forms, and quality records.
• Monitor training assignments and completion within MediaLab, partnering with leaders to ensure compliance with training requirements.
• Support internal audits, inspections, and accreditation activities, including preparation of documentation, records, and follow-up actions.
• Track, investigate, and document nonconformances, deviations, incidents, customer complaints, and quality events.
• Coordinate corrective and preventive action (CAPA) activities and ensure timely completion of assigned actions.
• Assist with root cause analyses and continuous improvement initiatives designed to improve quality, efficiency, and compliance.
• Collect, analyze, trend, and report laboratory quality metrics and key performance indicators.
• Support quality-related regulatory compliance activities associated with CLIA, CAP, AABB, ISO, NATA, or other applicable laboratory standards.
• Assist with vendor quality documentation reviews and supplier qualification activities as assigned.
• Facilitate quality meetings, maintain quality records, and prepare reports for management review.
• Assist in developing and delivering quality-related training and educational materials.
• Collaborate with laboratory operations, technical staff, and cross-functional teams to ensure adherence to established quality standards.
• Support laboratory readiness for audits and inspections through ongoing monitoring and process reviews.
• Identify opportunities to streamline workflows and strengthen quality processes.
• Other duties as assigned or become evident.

Qualifications:
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, AABB, ISO, NATA, or similar standards preferred.
• Strong organizational skills and attention to detail with the ability to manage multiple priorities simultaneously.
• 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 environment.
• Strong judgment, professionalism, and discretion when handling sensitive information.

_ Physical Requirements _
• Ability to sit, stand, and walk for extended periods.
• Frequent use of computers and standard office equipment.
• Ability to communicate effectively in person, by telephone, and electronically.
• Occasionally required to lift up to 25 pounds.
• May occasionally enter laboratory environments and must comply with applicable laboratory safety requirements and PPE protocols.

Additional Information

Compensation:

• Starting at $55,000/annual based on education and experience

Schedule:

• M-F Core Business Hours (9am-5:30pm)

What we offer:

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA Clinical Diagnostics is a Disabled and Veteran Equal Employment Opportunity employer.

Compensation:
$55,000-$55,000 per year