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 3,500 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.

Why Worldwide

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!

What the Quality Assurance Auditor Does at Worldwide

The Clinical Quality Assurance Auditor will have 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 (WORLDWIDE) processes and procedures, applicable regulations, and Sponsor SOPs, when necessary, with minimal supervision. Provides guidance on regulatory compliance to internal clients. The 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 team 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 the current status upon request.

• Assists with corrective and preventive action plans (CAPAs) to assure follow-up and implementation of corrections for internal and external audits.

• Oversee the maintenance of records for each audit.

What you will bring to the role

• Ability to read, execute, and understand complicated and detailed instruction or technical literature in order to plan, perform, and direct laboratory activities.

• Sound knowledge of applicable GxP regulations and requirements and Worldwide's policies and procedures.

• Ability to coordinate multiple projects and have the flexibility needed to adjust to changing priorities and unforeseen events.

• Ability to use logical inferences to understand the "big picture" and long-term implications of these issues.

Your experience

• Bachelor's degree, with a scientific focus, and five or more years of relevant work experience are required.

• Bachelor's degree preferably in life science or equivalent experience gained by working in a relevant area (clinical setting, laboratory, etc.).

• Minimum 3 years experience in regulatory affairs, auditing, clinical research, monitoring, laboratory, or other relevant area, of which 1-2 are in quality assurance auditing.