The primary job responsibility of the QA CAPA Specialist is to review and evaluate CAPA records and assist in proper completion according to the CAPA procedure. Monitor due dates and provide assistance for overdue CAPAs. Set-up meetings, maintain meeting minutes and prepare CAPA metrics for trending. Responsibilities: Develop and maintain CAPA procedures and work instructions. Ensure effective implementation of components of CAPA process, e.g. non-conformances, equipment out of tolerance findings, etc. Monitor due dates of CAPA phases and follow up with CAPA Owners. Prepare weekly CAPA metrics for trending. Investigate, document, report, and track the root cause of quality issues. Establish appropriate corrective actions and improvements. Conduct CAPA process training. Evaluate the effectiveness and efficiency of regulated processes throughout the organization and makes recommendations for improvement. Evaluate CAPAs for closure. Maintain CAPA Board Agenda and Meeting Minutes. Assist in preparation and follow up for Management Review meetings. Demonstrate behavior consistent with the Companys Code of Ethics and Conduct. Uphold the Companys core values of Integrity, Innovation, Accountability, and Teamwork. It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem. Duties may be modified or assigned at any time to meet the needs of the business.
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