CAPA Process Analyst
Company: Katalyst Healthcares & Life Sciences
Posted on: January 26, 2023
- 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
- 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
- Ensures effective written and verbal communications.
- Prioritizes workload in relation to the needs of the
- Supports the attainment of Client Hematology goals and
- Prerequisite skills: Knowledge of the Corrective and Preventive
Action process in medical devices Understanding of
- Experience with medical devices which have reagents, complex
electro-mechanical and optical components.
- Bachelor of Science in a life science or engineering
Keywords: Katalyst Healthcares & Life Sciences, Trenton , CAPA Process Analyst, Professions , Princeton, New Jersey
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