QA Coordinator (Lab Quality Experience Required)

Eurofins; Fairfield (OH); On-site; USD 55,000 - 62,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA Clinical Diagnostics, based in Fairfield, OH, seeks a QA Coordinator with lab quality experience to support the laboratory's QMS, document control, training, audits, CAPA, and quality metrics in a regulated diagnostic setting.

You will partner with the Laboratory Director and leadership to ensure CLIA/CAP/AABB/ISO compliance, manage MediaLab and related systems, and drive continuous improvement through CAPA and data analysis.

Qualifications

• Bachelor's degree in Biology, Business Management, or related field.
• Minimum 2 years in quality assurance, QC, lab operations, or regulated healthcare.
• Experience supporting lab quality systems, audits, accreditation, or regulatory compliance.
• Experience using quality management systems (MediaLab, MasterControl, TrackWise, Qualtrax) preferred.
• Knowledge of CLIA, CAP, AABB, ISO, NATA or similar standards preferred.
• Strong organizational skills and attention to detail.
• Analytical and problem-solving abilities.
• Strong written and verbal communication skills.

Responsibilities

• Coordinate day-to-day operation and maintenance of the laboratory QMS.
• Administer MediaLab and related quality management platforms.
• Manage document control: SOPs, forms, records, archival.
• Monitor training assignments and ensure compliance.
• Support internal audits, inspections, and accreditation activities.
• Track nonconformances, deviations, incidents, complaints, and quality events.
• Coordinate CAPA activities and ensure timely actions.
• Assist root cause analyses and continuous improvement initiatives.
• Collect and report quality metrics and KPIs.
• Support regulatory compliance for CLIA, CAP, AABB, ISO, NATA.
• Assist with supplier qualification and vendor documentation.

Skills

Quality Assurance

Quality Control

Lab operations

Regulatory compliance

MediaLab

MasterControl

TrackWise

Quality systems

Audits

CAPA

Education

Bachelor's degree in Biology/Business/related field

Tools

MediaLab

MasterControl

TrackWise

Qualtrax

Job description

QA Coordinator (Lab Quality Experience Required)

• Full-time
• Compensation: USD 55,000 - USD 62,000 - yearly

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 of products includes our 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. DDC is part of Eurofins, a global scientific company with over 950 laboratories in 60 countries and more than 65,000 employees.

*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

• 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.

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.