Amy has 16+ years’ experience in the biotechnology industry working in the areas of protein replacement therapies, gene therapies, and analytical methods development. As Director of Protein Services at GlycoSolutions Corporation, she was actively involved in continually improving their cGMP quality systems and processes. She has experience with control of monitoring and measuring of equipment and processes, verification, and validation activities.
Amy has a BS in Biochemistry, an MS in Applied Mathematics, and CQA (Certified Quality Auditor). She is an Exemplar Global Certified ISO 13485:2016 Lead Auditor and is actively involved helping various Medical Device companies with ISO 13485:2016 implementation and transition activities.