Quality related project management and process improvements across North America.

• Project Management; including CAPA owner, Process Improvements, Quality Plans (Investigator and team lead), Quality Investigations, Trending (Investigator and Designer), MRB chair, and Engineering Studies.• Led a gap analysis and quality plan project to align the site with USP <790> and manufacturing best practices for visual inspections.

• Manage Corrective Action and Preventive Action (CAPA) Projects• Non-conformance Report Investigations• Quality Investigations• Analysis and creation of trend charts• Other projects including validations, design changes, and procedural changes

• Corrective Action and Preventive Action (CAPA) Projects• Non-conformance Report Investigations• Quality Investigations

• Work in a multi-disciplinary team collaborating with other departments (Mechanical engineering and Biology) and with other schools (Arizona State University).• Set and achieve goals set by myself and employers. This has been shown among other things through the ability to Increase the mechanical properties of spider silk films over 20 times.• Focus on multiple projects and produce results; shown by one patent and two published peer reviewed articles.• Studied mechanical properties and surface characteristics of protein based films• Lead three different projects with protein based materials, including drug release and biocompatibility• Developed a new method of solubilizing and processing spider silk proteins

• Primed Bio-Process Containers for pharmaceutical companies• Learned and applied GMP in the work place• Led a 5S and Kaizen team improving production time and cleanliness in the formulation lab• Trained employees in aseptic technique and regulation compliance• Trained employees in class 1000 and class 10000 clean-rooms