Senior Auditor, Quality Assurance
Location: Austin, TX, USA
Requisition Number: 5545
Position Title: Senior Auditor, Quality Assurance
Who we are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of almost 2,500 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
What the Senior Auditor, Quality Assurance does at Worldwide
Will have in-depth experience and working knowledge in appropriate GxP compliance and other applicable regulations in order 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 current status upon request.
- Assist with the management of the Vendor Audit program.
- Facilitate sponsor audits/regulatory inspections, as assigned.
What you will bring to the role
- Sound knowledge of applicable GxP regulations and requirements as well as WCT policies and procedures.
- Ability to coordinate multiple projects and have the flexibility needed to adjust to changing priorities and unforeseen events.
- Excellent oral and written skills.
- Experience with Microsoft Word applications and to learn internal computer systems as necessary
- Bachelor’s Degree preferably in life science and a minimum five (5) years’ experience in regulatory affairs, auditing, clinical research, monitoring, laboratory, or other relevant area, three (3) of those years must be in quality assurance auditing. Additional experience in a relevant area (clinical setting, laboratory) that is deemed equivalent to education may be applied in lieu of the education requirement.
At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.
Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!
Employment Type: Regular
Community / Marketing Title: Senior Auditor, Quality Assurance
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: Austin, Texas US
CountryEEOText_Description: Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.