Skills Trypsinization of cells in culture and Cell Count and Viability Determination Survey of Microbial Characteristics and Harvesting Chromosomes ELISA Assay, SDS/Page and Replica Plating Auxotroph Western Blot and Environmental Testing Positive, Negative and Differential Staining Packaging and Labeling Control, Holding and Distribution Records, Reports and Signatures Laboratory Control Mechanisms and Microscopy Lyophilization and Protein Purification Formulation, Process Development and Technology Transfer Validation, Support Systems, Water Systems and Sterilization Facility and Clean room/ Isolator Design Technology Computer Validation and 21 CFR Part 11 Compliance and Training Requirements Quality Documentation War Room and Preparation for FDA Inspections Work May 2009-Present Shire Pharmaceutical Lexington, MA experience • Quality Documentation • Experience setting up the War Room for FDA Inspections as well as preparing for the FDA by making binders. • Being a runner for FDA Inspections • Audits • Writing and working on documentation • Helping overseas customers as well as our customers here in the United States • Working to meet all deadlines for projects in order to manufacture our products on time and in a timely manner. • Being really organized and organizing big projects that come at me at any given time. • Taking on new challenges daily • Working with the Training database system to ensure everyone has their training up to date to meet compliance. • Training on our QD documentation
2000-April 2009 Lowell Provision and Alpine Butcher Lowell, MA
• Butcher, Cashier, Customer Service • I have had experience working with the USDA at Lowell Provision for the past 8 years. I know the regulations that the USDA require.