Auditor I, Clinical Quality Assurance

Proven ability to manage multiple projects while maintaining quality

Working knowledge of MasterControl or other programs such as Veeva, or other related eQMS programs

Reasonable accommodations may be made upon request to enable individuals to perform essential functions.

Support GCP/GCLP/GVP audits for investigational sites, GCP internal systems and processes, trial master file and clinical service provider audits.

Responsibilities include the planning, coordination, and timely reporting of such audits as well as appropriate escalations of critical observations

Support and assist with commercial inspections, inspection readiness activities and other related activities as needed

Support GCP compliance activities including investigations, clinical change controls, procedure development and review, ATC QA audits, and GCP training program development

Represent the Clinical Quality Assurance Team in cross-functional projects where applicable