Senior Auditor, Quality Assurance (Contractor) - San Antonio - Office-based
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 the 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
Works with the QA Management to plan, conduct and complete written reports for each audit assigned.
Monitors the projects and audit status in assigned areas and provides status reports.
Assists with the management of the Vendor Audit program.
Facilitates sponsor audits/regulatory inspections.
Assists with review of audit reports to identify improvements that enhance the quality and clarity of the reports.
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.
Assists with creating and presenting GCP/GLP and other related training sessions.
Assists QA Management with review of WCT policies and procedures.
Oversees the maintenance of records for each audit.
What you will bring to the role
Sound knowledge of applicable GCP 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.
Ability to interact professionally and to work independently or in teams.
Excellent oral and written skills.
Your experience
Bachelor’s Degree, preferably in Life Science.
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.
Willingness to travel.
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.
Top Skills
What We Do
About Worldwide Clinical Trials Worldwide Clinical Trials is a global, midsize contract research organization (CRO) that provides top-performing bioanalytical and Phase I-IV clinical development services to the biotechnology and pharmaceutical industries. Founded in 1986 by physicians committed to advancing medical science, our full-service clinical experience ranges from early phase and bioanalytical sciences through late phase studies, post approval, and real-world evidence. Major therapeutic areas of focus include cardiovascular, metabolic, neuroscience, oncology, and rare diseases. Operating in 60+ countries with offices in North and South America, Eastern and Western Europe, and Asia, Worldwide is powered by its more than 3,000 employee experts. For more information, please visit www.worldwide.com or connect with us on Twitter, LinkedIn, Facebook, and Instagram.
