Nancy Baskharoun

About Nancy Baskharoun

I’ve always been drawn to the analytical and problem-solving nature of science, and I…

Experience

1. Senior Quality Assurance Manager

   Skye Biologics, Inc

   Jan 2022 — Present

   Responsibilities:• Establish and maintain the quality system to ensure facilities, equipment, personnel, methods, processes, and procedures conform to both internal guidelines and regulatory standards.• Work with cross-departmental leadership to deliver high-quality products on schedule.• Manage tissue bank renewal applications and associated regulatory submissions as well as maintenance of all current local, state, and federal licenses/certificates.• SOP Administrator of established Document Change Notice System performing all tasks related to control, tracking, employee training, and publishing approved documents while maintaining compliance with federal/state regulations and AATB standards.• Management of the CAPA system (Complaints, Deviations, NCRs, SCARs, CARs, BPDRs and Adverse Event Reports) to include report initiation, investigations, root cause analysis, tracking all corrective and preventive actions, and report closure. • Quality review of records related to donor screening, tissue acquisition, and processing/production batch records prior to release.• Audit liaison for all on-site/off-site audits by various local, state, and federal agencies as well as prepping HRT/Skye employees of audit expectations and processes.Accomplishments:• Validated an in-house environmental monitoring program for microbiology testing of the production area cutting result turnaround time in half while saving the company an average of annually on testing services. • Validated the use of vaginally acquired birth tissue as opposed to c-section only birth tissue which resulted in a substantial increase in locally acquired tissue donations as well as increased availability of birth tissue from various recovery agencies. This resulted in considerable acquisition cost savings.