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.