Clinical Quality Technologist
The Clinical Quality Technologist will support the maintenance and implementation of the quality assurance program as well as the development and evolution of the lab offerings. This staff member will report to the Clinical Quality Manager and work closely with the staff of the clinical genomic laboratory to achieve excellent and compliant service from the clinical facility and effectively manage customer interactions. This position requires a high degree of technical knowledge in molecular biology and virology.
• Write and review SOPs in collaboration with appropriate subject area experts, ensuring data integrity and compliance with company and regulatory standards.
• Assist in notifications to regulatory agencies, including reporting of infectious disease data.
• Support maintenance of quality indicator (QI) monitoring systems and assessment of QIs.
• Participate in investigations and root cause analysis for events in the lab, present solutions for improvement, and support evaluation of corrective and preventative (CAPA) effectiveness.
• Maintain laboratory quality and operations-related documentation, including logs, databases, and other miscellaneous paperwork.
• Support internal and external inspections and review documentation for GDP (good documentation practices).