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CAPA Quality Systems Analyst II

2 months ago

San Diego, California, United States KYYBA Full time
Job Overview

Position: CAPA Quality Systems Analyst II

Location: San Diego, CA

Contract Duration: 12+ months

Key Responsibilities:

As a CAPA Quality Systems Analyst II, you will play a crucial role in the administration of the CAPA system, ensuring its effective management across the organization.

Your responsibilities will include:

  • Overseeing the CAPA program at the site level and assisting process owners in the completion of CAPAs and associated business tasks.
  • Providing guidance and support to the Corrective Action Review Board and users regarding the CAPA process, documentation, and software tools.
  • Contributing to the development, execution, and ongoing enhancement of Quality System CAPA procedures, software applications, and training initiatives.
  • Ensuring the implementation and verification of CAPA effectiveness, while participating in the remediation of historical CAPA records.
  • Maintaining comprehensive CAPA records with accurate references to other Quality processes, including Change Management, Non-Conformance, and Complaint Handling.
  • Managing the archival and organization of scanned CAPA documentation.
  • Conducting critical reviews of documents, with a preference for experience in evaluating evidence related to claims or hypotheses.
  • Demonstrating a commitment to the establishment, execution, and effectiveness of the Quality Management System in compliance with ISO, FDA, and other regulatory standards.
  • Providing continuous support to Quality management during external audits.

Qualifications:

To be successful in this role, you should possess:

  • A Bachelor's degree or equivalent experience of 1-2 years in a regulated environment.

Professional Conduct:

It is essential to exhibit professional behavior that positively reflects the company’s values and policies while fostering productive relationships with both internal and external stakeholders.

Other duties may be assigned as necessary to meet the evolving needs of the business.