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CAPA Analyst

2 months ago


Santa Rosa, California, United States Collabera Full time
Job Overview

Collabera is seeking a skilled CAPA Analyst to join our team. As a key member of our quality assurance team, you will be responsible for leading investigations and implementing corrective actions to ensure the timely and compliant introduction of new/improved products, processes, and systems.

Key Responsibilities
  • Lead cross-functional teams in the use of investigational tools to determine the root cause of nonconformities and ensure that CAPA plans address root causes.
  • Ensure that actions are on time, thorough, complete, and meet the needs of the business and customers, and that required standards and/or procedural requirements are met.
  • Investigate complex and highly technical quality issues to ensure the timely completion of CAPA system activities raised for nonconformances, potential nonconformances, CAPAs, deviations, and/or complaint investigations.
  • Maintain the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.
  • Produce trending metrics and reports to identify, prioritize and manage further actions, as may be required.
Requirements
  • Bachelor's degree in engineering or Life Sciences
  • Experience with Corrective and Preventative Action process in medical devices or laboratories
  • Excellent communication and technical writing skills

Pay Range: $30/hr - $35/hr