Quality Assurance Auditor - US - Houston

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 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.

• 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.

• 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 of these issues.
• Assist QA management with review of audit reports to identify improvements that enhance the quality and clarity of the reports.
• Strong communication skills and ability to work both independently and within a team environment professionally.
• Excellent oral and written skills.
• Strong time management and organizational skills with excellent attention to detail.
• Ability to meet deadlines with high quality of work.
• Ability to prioritize work and define steps needed to achieve assigned project goals.
• Ability to speak, read and write English fluently.
• Experience with Microsoft Word applications and the ability to learn internal computer systems as necessary.
• Knowledge of the clinical research process, including Good Clinical Practices, informed consent process, drug accountability procedures, and IRB submission and reporting.

• Bachelor’s degree preferably in life science or equivalent experience gained by working in a relevant area (clinical setting, laboratory, etc.).
• Minimum of 3 years’ experience in regulatory affairs, auditing, clinical research, monitoring, laboratory, or other relevant area, of which 1-2 years are in quality assurance auditing.
• Possible physical demands include, but are not limited to: lifting and carrying of objects weighing 5-50 lbs., hearing, seeing, gross and fine motor use of upper extremities, kneeling, walking, standing, leaning over for extended periods of time, squatting, eye strain/fatigue, climbing, pushing, pulling, reaching, and exposure risk to potentially infectious blood and/or body fluids, and/or hazardous fumes or chemicals.
• Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

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 .

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.