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CAPA Process Analyst

2 months ago

San Diego, United States Intellectt Inc Full time

Role: CAPA Process Analyst II

Location: San Diego, CA


Description:

  • Exempt/Non Exempt: Non-ExemptYears Experience: 4+ YearsThe CAPA Process Analyst II:- Progresses investigations and other activities through the CAPA program.
  • Leads cross-functional teams in the use of investigational tools to determine the root cause of nonconformities, ensures that CAPA plans address root causes and that CA/PAs are implemented timely to facilitate the rapid and compliant introduction of new/improved products, processes, and systems.
  • Ensures 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. - Leads a multifunctional team, ensuring that all communications, interpersonal interactions, and business behaviors are consistent with the Abbott Code of Conduct.


  • Main Responsibilities:
  • Leads the investigation of 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.
  • Is a subject matter expert on investigation and root cause analysis techniques to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance.
  • Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.Ensures all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner.
  • Bachelor of Science in a life science or engineering discipline