What are the responsibilities and job description for the Lead GCP Quality Assurance Auditor position at Dexian?
GCP Lead Quality Assurance Auditor
Position location: Remote
This role requires up to 25% domestic travel to the DC/MD/VA area and 1-3 international trips annually.
Job Description
Supports the maintenance and upkeep of the Quality Management System.
Maintains the Quality Assurance (QA) training program, document control, customer complaint program and CAPA program.
Supports audits of clinical sites and vendors/suppliers.
Supports internal audit program and performance metrics system for continual improvement.
Manages the review cycle of QA controlled documents to assure practices reflect written procedures.
Supports regulatory agency audits.
Job Requirements
Knowledge of current GCP regulations.
Experience in working with regulatory agency audits.
Experience in working with Quality Systems for CROs.
Excellent written/verbal communication skills.
Proficiency in MS Office.
Dexian stands at the forefront of Talent Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority-owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting-edge technologies to deliver comprehensive global services and support.
Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results that help everyone achieve their ambitions and goals. To learn more, please visit https://dexian.com/.
Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.