Capa Process Analyst Jobs

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Role: CAPA Process Analyst
Location: San Diego, CA
Job Responsibilities

• Support and guide the Corrective Action Review Board and Users regarding the CAPA process, CAPA record content, and CAPA software.
• Support the development, implementation and continuous improvement of Quality System CAPA procedures, CAPA software, and CAPA training.
• Other duties as assigned, according to the changing needs of the business.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices; build productive internal/external working relationships.
• Demonstrates commitment to the development, implementation and effectiveness of ARDx Quality Management System per ISO, FDA, and other regulatory agencies.
• Critical Review of documents. Experience in assessing the weight of evidence associated with a claim/hypothesis/assertion is preferred.
• Carries out duties in compliance with established business policies.
• Ensure that CAPA records are complete and they contain accurate links and references to other Quality processes such as Change Management, Non-Conformance, and Complaint Handling.
• Provide site administration of the CAPA program and support process owners in completing CAPAs and related business items.
• Provide ongoing support to Quality management during external audits.
• Ensure implementation, and effectiveness verification of CAPA and participate in remediation of legacy CAPA files.
• Manage the archival and handling of scanned CAPA records.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.