Title:CAPA Process Analyst II
Location:Santa Rosa, CA
Contract:6+ months
Job summary:
Leads the investigation of complex and highly technical quality issues to ensure the timely completion of CAPA system activities raised for non conformances, 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 Preventative 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.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.
