What are the responsibilities and job description for the Quality Assurance Auditor - US position at Worldwide Clinical Trials?
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
Your experience
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.
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 know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We're on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. 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
