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 3,000 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.
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.
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 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 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 provide QA Management with the current status upon request
Assists with corrective and preventive action plans (CAPAs) to ensure 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 to plan, perform, and direct laboratory activities
Sound knowledge of applicable GxP regulations and requirements and Worldwide 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
A Bachelor’s degree, with a scientific focus, and 3 or more years of relevant work experience are required
Minimum 3 years experience in regulatory affairs, auditing, clinical research, monitoring, laboratory, or other relevant area
1-2 years of quality assurance auditing or GCP experience
Who we are
Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.
Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!