Quality Assurance Auditor - US - Remote

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 over 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

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!

What the Quality Assurance Department does at Worldwide 

The Quality Assurance department sets the bar high when it comes to quality. We are committed to exceeding quality standards required by our sponsors, study participants, and regulatory authorities. Our QA culture is based on an environment where staff are trained, energized, and empowered to deliver high-quality products to our employees and customers. 

What you will do 

• Always representing Worldwide in a professional manner (verbal, written, and in appearance) when interacting with sponsors, volunteers, outside vendors, and fellow employees. 

• Works with QA team to plan, conduct and complete written reports for each audit assigned. 

• Monitors the projects and audit status in assigned areas and provides QA Management with current status upon request. 

• Fosters a good working relationship with internal clients and QA team. 

• Identifies areas for process improvement and provides this information to management. 

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

• Provides advice and guidance on regulatory requirements and SOPs. 

• Assists with training and mentoring of less experienced auditors. 

• Oversees the maintenance of records for each audit. 

• Performs Vendor audits as required. 

• Assists with creating and presenting GCP/GLP and other related training sessions. 

• Attends Protocol and Project Risk Assessment Review meetings to provide Quality input. 

• Minimal travel may be required. 

• Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. 

What you will bring to the role 

• Sound knowledge of applicable GxP regulations and requirements as well as 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