Quality Assurance Auditor

PSI is a leading Contract Research Organization with 30 years in the industry offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.Job DescriptionSCOPE OF RESPONSIBILITIES1. Communication1.1. Serves as the communication point to project teams with regard to quality assurance (QA) study audits1.2. Follows up with project teams with regard to resolution of PSI QA study audits1.3. Liaises with PSI divisions/operational offices with regard to internal systems, process, and location audits1.4. Liaises with vendors with regard to vendor qualification audits1.5. Serves as the communication point for PSI Operations staff with regard to issues related to quality assurance1.6. Serves as the communication point for PSI clients with regard to QA audits contracted to PSI2. Planning and scheduling2.1. Prepares, conducts, and reports QA study audits2.2. Assembles QA study audits documentation2.3. Takes part in the preparation, conduct, and reporting of internal systems audits2.4. Takes part in the preparation, conduct, and reporting of internal locations audits2.5. Takes part in the preparation, conduct, and reporting of vendor qualification audits2.6. Takes part in the preparation, conduct, and reporting of internal process audits3. Training3.1. Trains PSI Operations staff in quality management topicsQualifications1. Bachelor or above degree in life science or an equivalent combination of education2. Minimum of 3 years in quality management or quality assurance, 2 to 3 supervised QA audits is a must3. Full working proficiency in English and Japanese4. Communication, presentation, and customer-service skills5. Team building, leadership and organizational skills6. Proficiency in MS Office applications, including MS Project Additional InformationMake the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.