Quality Investigation Specialist (13)

Summary

Conducting investigations of non-medical quality incidents, the full-time Quality Investigation Specialist will coordinate corrective and preventive actions (CAPA) while ensuring compliance with FDA regulations and collaborating with various stakeholders to maintain high safety standards.Key responsibilitiesParticipate in the investigation of non-medical quality incidents, utilizing online quality management software to facilitate and document activitiesCoordinate and lead assigned CAPA, including root cause analysis, planning corrective actions, and monitoring effectiveness checksEngage in process improvement projects related to incident management and regulatory compliance as assignedRequired qualificationsBachelor's degree in Healthcare or Science preferred, or equivalent related experienceFive years of experience in a healthcare or science environment, with two years focused on investigation and resolution of complaintsStrong knowledge of quality assurance principles, risk management, and cellular therapy operationsProficiency in relevant computer software applications, including Windows, Word, Excel, and databasesAdvanced interpersonal skills for effective collaboration and complex problem-solving

Job Description

Conducting investigations of non-medical quality incidents, the full-time Quality Investigation Specialist will coordinate corrective and preventive actions (CAPA) while ensuring compliance with FDA regulations and collaborating with various stakeholders to maintain high safety standards.Key responsibilitiesParticipate in the investigation of non-medical quality incidents, utilizing online quality management software to facilitate and document activitiesCoordinate and lead assigned CAPA, including root cause analysis, planning corrective actions, and monitoring effectiveness checksEngage in process improvement projects related to incident management and regulatory compliance as assignedRequired qualificationsBachelor's degree in Healthcare or Science preferred, or equivalent related experienceFive years of experience in a healthcare or science environment, with two years focused on investigation and resolution of complaintsStrong knowledge of quality assurance principles, risk management, and cellular therapy operationsProficiency in relevant computer software applications, including Windows, Word, Excel, and databasesAdvanced interpersonal skills for effective collaboration and complex problem-solving