The Jackson Laboratory for Genomic Medicine, based in Farmington, CT is seeking a Clinical Quality Assurance Manager to coordinate the implementation, execution, and compliance with Quality Management programs governing the JAX Genomic Medicine clinical service offerings. In this role, you will work closely with the management and staff of the clinical genomic laboratory to achieve excellent and compliant service from the JAX Genomic Medicine clinical facility.
• Develop and Maintain the JAX Genomic Medicine clinical Quality Management program in coordination with JAX-wide clinical services offerings, enterprise quality management systems, and all applicable regulations.
• Manage QM documentation for CAPA, errors and incidents, and indicators of quality including customer satisfaction and vendor notifications.
• Ensure quality metrics preparation and review.
• Administer the annual, clinical laboratory director approved, quality initiative.
• Coordinate employee competency and proficiency testing.
• Maintain quality related documentation, including method and process validation documentation, and coordinate initial annual clinical document review.
• Support the Product Development efforts and provides input to and/or approves protocols, reports, inspection instructions, controls etc. for developing products and services.
• Work with clinical laboratory management to identify critical procedures and processes and evaluate on an on-going basis.
• Develop and maintain an integrated training program to include the on-going training, testing, and evaluation of clinical employees on critical processes.
• Perform auditing of clinical services areas to assess continued compliance and adherence to documented procedures and policies.
• Support auditing of operational procedures to identify those procedures not appropriately documented and areas for improvement and standardization among facilities.
• Audit clinical services area in coordinated compliance with JAX-wide Quality Systems group.
• Work collaboratively with clinical laboratory management to implement immediate corrective actions to mitigate the concern and subsequently identify preventive measures and processes to ensure the problem does not re-occur.
• Perform root cause investigations and analysis of deviations including developing and implementing preventive actions to mitigate future occurrences.
• Participate in and/or host third party audits.