Senior Quality Auditor

Job Description

• Supporting the Quality Management System including SOPs, training and CAPA.
• Developing and administering training for employees and/or consultants.
• Hosting client/sponsor audits and supporting regulatory inspections.
• Coordinating and conducting assessments of potential and contracted vendors, including vendor audits as warranted.
• Coordinating and conducting internal audits of quality systems.
• Coordinating and conducting investigator site audits.
• Coordinating and conducting trial master file audits.
• Participating on computer systems validation projects and systems change control process.
• Providing QA consultation and support to assigned project teams internally and externally.
• Supporting and managing reported quality issues and any associated corrective and preventive actions.
• Monitoring quality systems to provide feedback on compliance risks to QA management and identify opportunities for improvement.
• Maintaining Q&C trackers, databases, metrics, and files.

• 4 years industry experience.
• Clinical research experience in non-QA role considered (e.g., clinical research associate experience).
• Working knowledge of GCP/ICH guidelines and FDA regulations and standards.
• Bachelor’s degree in a science, healthcare, or related field of study; combination of qualifications and equivalent relevant experience may be accepted as an alternative.
• Availability to travel up to 25% domestically and/or internationally.
• Excellent interpersonal and problem-solving skills, effective verbal and written communication, computer skills.
• Strong knowledge of GCP/ICH guidelines and FDA regulations and industry standards.
• Intermediate proficiency in Microsoft Word, Excel, and PowerPoint.
• Must possess a customer service demeanor; demonstrate collaboration and flexibility, teamwork, and a keen attention to detail.
• Ability to work independently and in a team environment.
• Ability to work with cross functional groups and management under challenging situations.
• Ability to prioritize work and handle multiple and/or competing assignments.
• Results oriented, accountable, motivated and flexible.
• Demonstrates values and a work ethic consistent with Precision Values and Company Principles.
• Excellent verbal and written communications skills.
• Fluent in English language and for non English speaking countries, the local language of country where position is based

• Opportunity to support quality and compliance activities in clinical research.
• Chance to work with cross-functional teams and management.
• Exposure to various aspects of quality management systems.