Clinical Auditing Specialist II - Vendor and Information System Audits

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions: Office Job Description: Join us as Quality Assurance Auditor II (Internal Information System Audits Team) and enhance our clinical auditing processes by ensuring regulatory compliance and quality standards. What You’ll Do: - Conduct and/or lead internal information systems audits as requested by senior management including but not limited to computerized systems used in clinical trials, data integrity and security of internal facility systems and instrumentation, computerized system lifecycle management processes, and study build configuration user acceptance testing. - Provide GxP consultation and support to project teams and internal clients regarding information systems compliance including but not limited to 21 CFR Part 11 and EMA guideline on computerized systems used in clinical trials. - Serve as a knowledgeable resource to operational departments on audit or quality assurance subject matter - Prepare and present audit findings and/or other related information at departmental and internal operations meetings Education and Experience: In some cases, an equivalency, consisting of a combination of appropriate education,...