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.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. This role is fully remote to those in/willing to relocate to Maryland, Virginia, or Washington D.C.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.
This role is fully remote to those in/willing to relocate to Maryland, Virginia, or Washington D.C.