Quality Assurance Coordinator

Company Overview

DNA Diagnostics Center, LLC (DDC) is the world leader in DNA relationship testing, processing over one million DNA samples from customers all over the world. Our broad portfolio includes Paternity, Immigration, and other DNA Relationship services for consumers, government agencies, healthcare providers, and legal professionals; PeekabooTM Early Gender DNA Test for expecting mothers; SpermCheck fertility and vasectomy test; and Pets & Vets DNA testing for breeders and pet enthusiasts. Our corporate headquarters, including our DNA testing laboratory, is based in Fairfield, OH in the greater Cincinnati Area.

Opportunity Overview

DDC is seeking a Quality Assurance Coordinator to support the administration, maintenance, and continuous improvement of the laboratory Quality Management System (QMS).

Essential Duties & Responsibilities

• Cook up 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.
• Cook up corrective and preventive action (CAPA) activities and ensure timely completion of assigned actions.
• Aid in 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.
• Aid in quality-related regulatory compliance activities associated with CLIA, CAP, AABB, ISO, NATA, or other applicable laboratory standards.
• Aid in vendor quality documentation reviews and supplier qualification activities as assigned.
• Cook up quality meetings, maintain quality records, and prepare reports for management review.
• Aid in developing and delivering quality-related training and educational materials.
• Cook up collaboration with laboratory operations, technical staff, and cross-functional teams to ensure adherence to established quality standards.
• Aid in supporting 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

• 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.
• 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.
• The ability to analyze data and identify trends, risks, and opportunities for improvement.
• Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint.
• The 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.