Clinical Auditing Specialist III
3 weeks ago
Perform risk based review of highly complex validated systems
Lead directed site audits, facility, vendor, and/or sub-contractor audits
Provide GxP consultation and support to project teams and external clients
Lead process audits and may participate as a co-auditor in more complex system audits
Perform other types of QA audits or activities such as internal audits, non-conformance review and investigation review.
Serve as a resource to operational departments on audit or quality assurance subject matter
Prepare and present audit findings and related information at departmental, internal operations, or client meetings
Attend site as required in order to perform client audits, regulatory inspections, internal audits and other activities as required
Provide mentorship and guidance to junior auditors
Requirements:
Bachelor's degree in a related field
Minimum of 5 years of experience in clinical auditing or quality assurance
Strong knowledge of GxP regulations and guidelines
Exceptional attention to detail and ability to ensure flawless execution of audits
Proven ability to successfully implement audit processes and procedures
Excellent communication and presentation skills
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
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