Auditor, Quality Oversight Vendors and Digital Data - US/Canada - Remote

Worldwide Clinical Trials; North Carolina; Remote; USD 70,000 - 90,000; Full time

Job summary

A global clinical research organization is seeking an Auditor for Quality Oversight of vendors and digital data. The role involves performing quality audits to ensure compliance with regulations and internal processes. Candidates should have a Bachelor’s Degree in a relevant field and at least 2 years of Quality Assurance audit experience. This position is remote, with some domestic and international travel required.

Qualifications

• At least 2 years of Quality Assurance audit experience.
• Good understanding of GCP Quality Management System principles.
• Working knowledge of drug development lifecycle and Good Clinical Practice.
• Familiar with ICH Guidelines, FDA regulations, and European Directives.

Responsibilities

• Perform quality audits for Vendors and Internal Processes.
• Support investigation and resolution of vendor-related quality issues.
• Ensure compliance with regulations and internal processes.
• Participate in continuous process improvements.

Skills

Organizational skills

Critical decision making

Project management skills

Effective communication

Resourcefulness

Prioritization

Education

Bachelor’s Degree in nursing, biological, physical, health, pharmacy or related field

Job description

Auditor, Quality Oversight Vendors and Digital Data - US/Canada - Remote

Join to apply for the Auditor, Quality Oversight Vendors and Digital Data - US/Canada - Remote role at Worldwide Clinical Trials

We’re Worldwide Clinical Trials, a global midsize CRO with a mission to improve lives by delivering high-quality work for sponsors, study participants and regulators. We are a diverse, inclusive team of experts dedicated to quality and excellence.

What You Will Do

• Serves as a positive ambassador of the Quality organization with internal and external customers.
• Performs quality audits for Vendors, Internal Process/Computer Systems and other audits, as assigned.
• Ensures quality deliverables, on time, and in compliance with regulations and Worldwide processes, as assigned.
• Supports the investigation and resolution of vendor-related quality issues.
• Quality Assurance review of computer system validation documentation.
• Participates in driving continuous process improvements.
• Ensures data and record management in accordance with the QMS.
• Communicates relevant regulatory intelligence that impacts the QMS to the Quality team, if identified.

What You Will Bring To The Role

• Ability to work remotely with minimal supervision and guidance.
• Demonstrates good organizational skills and critical decision-making.
• Demonstrates good decision making and project management skills.
• Effective communicator that is concise, clear, and consistent to external and internal customers both verbally and in writing.
• Demonstrated initiative and resourcefulness while working with a sense of urgency.
• Demonstrated ability to prioritize work with some supervision.

Your Experience

• Bachelor’s Degree with concentration in nursing, biological, physical, health, pharmacy or other related scientific or allied health field and at least 2 years of Quality Assurance audit experience.
• Good understanding of the principles for a GCP Quality Management System.
• Working knowledge of the drug development lifecycle and Good Clinical Practice.
• Working knowledge of ICH Guidelines, FDA regulations, European Directives, MHRA Statutory Instruments.
• Domestic and international travel required (approximately up to 50%).

Equal Employment Opportunity

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. 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.

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, visit www.Worldwide.com or connect with us on LinkedIn.

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