What are the responsibilities and job description for the Senior Auditor, Quality Assurance IN OFFICE AUSTIN, TX position at Worldwide Clinical Trials?
What the Senior Auditor, Quality Assurance does at Worldwide
To have in-depth experience and working knowledge in appropriate GxP compliance and other applicable regulations to conduct various types of audits to assess Worldwide Clinical Trials (WCT) Worldwide Clinical Trials (WCT) processes and procedures, applicable regulations and Sponsor SOPs, when necessary. Provides guidance on regulatory compliance to internal clients. Provides direction and coordination of project activities related to assigned areas in liaison with QA management. Mentors other QA auditors. The Senior (Sr.) Quality Assurance Auditor works under the general supervision and guidance of the Manager, QA, Sr. Manager, QA, Director, QA or Sr. Director, QA.
What you will do
- Work with the QA Management to plan, conduct and complete written reports for each audit assigned.
- Monitor the projects and audit status in assigned areas and provides QA Management with status upon request.
- Assist with the management of the Vendor Audit program.
- Facilitate sponsor audits / regulatory inspections, as assigned.
- Assist QA Management with review of audit reports to identify improvements that enhance the quality and clarity of the reports.
- Assist with corrective and preventive action plans (CAPAs) to assure follow-up and implementation of corrections for internal and external audits
What you will bring to the role
Your experience
