Quality Assurance Coordinator

Eurofins USA Clinical Diagnostics; Philadelphia (Philadelphia County); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA Clinical Diagnostics is seeking a Laboratory Quality Assurance Coordinator to lead the quality management system, ensure regulatory readiness, and support inspections. The role emphasizes documentation, audits, CAPAs, and staff training in a fast-paced clinical lab environment.

Responsibilities include oversight of QMS, change management, training, and supplier qualification while ensuring compliance with CAP, CLIA, ISO, and FDA guidelines.

Qualifications

• Bachelor's degree in a chemical, physical, biological science, or MLS/MT.
• Minimum 5–7 years in a clinical or analytical lab with QA/QC experience.
• Strong knowledge of quality management systems (ISO/CLIA/CAP) and regulations.
• Proficiency with LIMS and MS Office; excellent communication skills.

Responsibilities

• Develop and maintain the laboratory's QMS, policies, and procedures.
• Ensure regulatory compliance with CAP, CLIA, ISO, and FDA standards.
• Coordinate internal and external audits, manage CAPAs and corrective actions.
• Oversee document control and records, track nonconformances and deviations.
• Log change requests, manage approval workflows, and ensure documentation before closure.
• Design and deliver training on quality procedures to staff.
• Investigate non-conformances and incidents; perform root-cause analysis.
• Schedule QA meetings, capture minutes, and liaise with other departments.
• Oversee Supplier Qualification and ASL documentation.

Skills

Attention to detail

Organizational skills

Analytical thinking

Problem solving

Communication

Data interpretation

Statistical analysis

Independent work

Team collaboration

Education

Bachelor's degree in a chemical/physical/biological science

Tools

LIMS

Microsoft Office Suite

Job description

Job Description

The Laboratory Quality Assurance (QA) Coordinator is responsible for ensuring that DPT’s quality system is well-documented, traceable, and compliant. This role focuses specifically on regulatory readiness documentation and inspection support. Role is critical in tracking, organizing, and executing the administrative an procedural backbone of the laboratories’ quality program.. This position ensures compliance with federal, state, and local regulations (e.g., CLIA, CAP, ISO, FDA) and drives continuous quality improvement initiatives. The QA Coordinator develops and maintains policies, conducts audits, manages documentation, and trains staff on quality procedures.

Key Responsibilities:

• Quality Management System (QMS) Oversight: Develops, implements, and maintains the laboratory's comprehensive quality management system, including the Quality Manual, policies, and procedures.
• Regulatory Compliance: Monitor and ensure continuous compliance with all applicable accreditation and regulatory standards (e.g., CAP, CLIA, ISO 15189, GxP, FDA).
• Audits and Inspections: Coordinate and participate in internal and external audits/inspections, manage the response to findings, and implement corrective and preventive actions (CAPAs). Assist in preparing audit schedules and checklists. Track corrective actions and verify closures. Organize and maintain documentation needed for audits and inspections. Assist in preparing materials and responses for regulatory and accrediting inspections and client audits.
• Documentation and Record Control: Oversees the documentation control system.. Logs and tracks nonconformances, deviations and incident reports. Ensures completeness and accuracy of quality records.
• Change Management Support: Log and monitor change requests. Track approval workflows and implementation timelines. Assist in collecting / reminding of required objective evidence for activity / file closure. Ensure related documentation is complete before closure.
• Training and Education: Develop and conduct training sessions for staff on quality standards, new procedures, and best practices to promote a quality culture. Send reminders for upcoming and overdue training, as applicable.
• Event and Risk Management: Assist in investigation of non-conformances, errors, and incidents; perform root cause analysis; and determine corrective actions to mitigate future risks. Ensure timeliness of all activities to meet regulatory expectations. Develop tools to assist with tracking activities / actions.
• Communication and Coordination: Schedule QA Meetings and take meeting minutes. Communicate deadlines, updates and quality-related notifications. Serve as liaison between QA and other departments.
• Supplier Qualification Program: Develop schedule to ensure Approved Supplier List (ASL) is kept up-to-date. Ensure qualification / re-qualification documentation is current and filed appropriately. Participate in vendor-related SCAR issuance, receipt of responses and assuring documentation meets DPT’s requirements.

Qualifications:
Qualifications

Required Qualifications and Skills:

• Education: Bachelor's degree, preferably in a chemical, physical, biological science, or Medical Laboratory Science (MLS/MT) from an accredited institution.
• Experience: Minimum of 5-7 years of experience in a clinical or analytical laboratory environment, with demonstrated experience in quality assurance or quality control.
• Knowledge: Strong knowledge of quality management systems (e.g., ISO, CLIA, CAP) and relevant federal/state regulations.
• Skills: * Excellent attention to detail and strong organizational skills. * Strong analytical and problem-solving abilities, with an aptitude for data interpretation and statistical analysis. * Excellent written and verbal communication skills, with the ability to effectively communicate with diverse staff and management. * Proficiency with laboratory information management systems (LIMS) and Microsoft Office Suite. * Ability to work both independently and collaboratively in a fast-paced environment.

Preferred Qualifications:

• Certification in quality management (e.g., Certified Quality Auditor (CQA) or Six Sigma certification).
• Experience with specific laboratory certifications/standards relevant to the lab's specialty (e.g., ASHI, CAP, CLIA,)

Additional Information

Compensation:

• $70,000-$95,000 salary

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:
$70,000-$70,000 per year