CAPA Process Analyst II

Hello this is Komal from Intellectt we have an opening for a CAPA Process Analyst II in Santa Rosa, CA. Please find the job details and description below and if interested You can reach me at [email protected] or call me at +1(732)-813-9025.

Role: CAPA Process Analyst II

Location: Santa Rosa, CA - 95403

Duration: 5 Months

Shift Timings: 8 AM to 5 PM

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/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 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 Abbott Toxicology Laboratories goals and objectives.
• Ensures compliance to organizational procedure, regulatory requirements and industry standards and timely completion of CAPAs and audit findings.
  
  

Required Qualifications:

• Bachelor’s degree in engineering or Life Sciences
• Experience with Corrective and Preventive Action process in medical devices or laboratories
• Excellent communication and technical writing skills
  
  

Preferred Qualifications:

• Understanding of statistics, FMEA and a ASQ CQE
• Knowledge of Quality requirements within Clinical Laboratory Improvement Amendments (CLIA),
• College of American Pathologists (CAP) regulations or similar regulated industry.