CAPA Process Analyst II at The Fountain Group
Santa Rosa, CA
About the Job
Pay: $30-35/hr
Location: Santa Rosa, CA OR Gretna, LA
Duration: 7 month contract initially
Job Description:
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
Prerequisite skills:
Location: Santa Rosa, CA OR Gretna, LA
Duration: 7 month contract initially
Job Description:
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 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.
- 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 Preventative Action process in medical devicesUnderstanding 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
