Arqule Pharmaceuticals Inc./Merck
Senior Consultant, Quality Assurance
3Dbio
Consultant
Biostage, Inc. Oct 2016 - Jun 2017
Consultant - Complya Consulting
Biomedical Resource Consultants Oct 2016 - Jun 2017
Quality Assurance and Regulatory Compliance Consultant
Biodirection 2016 - 2016
Consultant
Education:
Boston University 1987 - 1990
Masters, Biology, Biochemistry
Suffolk University 1982 - 1986
Bachelors, Bachelor of Arts, Marine Biology, Biology
Skills:
Regulatory Compliance Quality Assurance Design Assurance Iso 13485 Capa Fda Quality System Design Control Iso 14971 Medical Devices Validation Cqa Gmp Change Control Quality Auditing Root Cause Analysis Regulatory Affairs Quality Management Manufacturing Regulatory Requirements Continuous Improvement Computer System Validation Fmea Minitab Gxp Quality Control Dmaic Sop Supplier Quality Design of Experiments Iso Ce Marking R&D Complaint Management Aseptic Processing 21 Cfr Supplier Evaluation Cross Functional Team Leadership Spc Lean Manufacturing Fda Gmp Iso 9000 Management Review Corrective and Preventive Action Injection Molding U.s. Food and Drug Administration