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CAPA Process Analyst

Company: Katalyst Healthcares & Life Sciences
Location: Princeton
Posted on: January 26, 2023

Job Description:


  • Years' Experience: 4+ Years
  • The 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/Client 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 Client 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 non conformances, 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.
  • Produces trending metrics and reports to identify, prioritize and manage further actions, as may be required.
  • Provides leadership for the initiation of improvement activities associated with identified trends.
  • Is an active leader supporting a work environment that ensures team effectiveness by demonstrating full cross functional team support that complies with Corporate and regulatory requirements.
  • Ensures effective written and verbal communications.
  • Prioritizes workload in relation to the needs of the business.
  • Supports the attainment of Client Hematology goals and objectives.
  • Prerequisite skills: Knowledge of the Corrective and Preventive Action process in medical devices Understanding of statistics
  • Experience with medical devices which have reagents, complex electro-mechanical and optical components.
  • Bachelor of Science in a life science or engineering discipline

Keywords: Katalyst Healthcares & Life Sciences, Trenton , CAPA Process Analyst, Professions , Princeton, New Jersey

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