Education & Professional Experience

has studied at Colorado State University in Microbiology.

worked for Fresenius Kabi as Senior Manager, FDA Compliance between May 2020 and Nov 2020, for Particle Measuring Systems as Principal Advisor, Global cGMP- Sterility Assurance Expert between Nov 2017 and May 2020, for Indivior as Global R&D QA Manager between May 2014 and Nov 2017, for Hospira as QA Compliance Manager between Feb 2013 and May 2014, for Barry-Wehmiller Design Group as Senior Validation Engineering Consultant between 2012 and 2013, for Dohmen Life Science Services as QA Project Manager (Reglera) between 2011 and 2011, for Amgen as QC Microbiology Manager between 2007 and 2011, for Insmed as QA Validation Manager between 2006 and 2007, for Eyetech Pharmaceuticals as Compliance Manager between 2005 and 2005.

 Skills & Competences

has the following skills : Process Improvement, Aseptic Technique, ISO 13485, GMP, Six Sigma, Biotechnology, Medical Devices, CAPA, Microbiology, Quality Auditing, Quality Assurance, FDA, Regulatory Affairs, Change Control, Quality System, Manufacturing, Validation, HPLC, Quality Management, Technology Transfer.

speaks the following languages : Spanish.