Senior Auditor, Quality Assurance (Contractor) - San Antonio - Office-based

Worldwide Clinical Trials•San Antonio, TX

1d•Onsite

About The Position

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.

Requirements

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.
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.
Willingness to travel.

Responsibilities

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.