Ashley Lucci-Vaughn

Washington D.C. Metro Area United States

Director of QA/QC at Omnia Biologics

Medical / Health Care / Pharmaceuticals

Educated on a range of software and use of different databases with extensive training in Microsoft Office Programs. Experience working under Good Operational Procedures. Extensive work experience with global quality systems including auditing, CAPA’s, NCR’s, deviations, performance/process improvement. Working experience in the following regulated environments: European Medical Device Directive, In Vitro Device Directive, Canadian Medical Device Regulation, FDA, CLIA, CAP, ISO 15189, 9001:2000, ISO 13485,and 21 CFR requirements (including but not limited to part 11, 50-58, 312, 812-820). Skilled in Lean Six Sigma methodologies, process improvement and auditing. Accomplished in multi-a