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�.'alvin, Giordano & Associates, <br />Created a new calibrator manufacturing adjustment and data analysis technique that resulted in more <br />accurate final concentrations with fewer adjustments. Developed the statistical analysis procedure for data <br />generated during manufacturing. Created the software program for use by manufacturing personnel on the <br />shop floor. Prepared a software validation protocol for the adjustment procedure and data analysis <br />technique. Performed validation per FDA guidelines and prepared all supporting documentation. Composed <br />a Standard Operating Procedure (SOP) for the technique and prepared training and operating manuals. <br />Conducted training classes for all manufacturing personnel. <br />Designed and implemented a database to store reagent manufacturing data for Statistical Process Control <br />(SPC) and troubleshooting activities. Data was generated and entered in the database from both Miami and <br />Puerto Rico manufacturing facilities. <br />Performed troubleshooting of Stratus® instrument problems. <br />Supervised four scientists and managed the technical support laboratory. <br />Project Engineer, Exxon Research and Engineering Company, Linden, NJ (1981- 1982). Duties and <br />accomplishments in the chemical research department: <br />• Designed bench scale pilot units for research staff. <br />• Estimated cost and manpower for pilot plant construction. <br />• Contacted vendors and procured quotes. <br />• Performed start -up of pilot units. <br />ACTIVITIES AND HONORS <br />Society of Omega Chi Epsilon (Chemical Engineering Honorary), Graduated Cum Laude from Mercersberg Academy <br />- Mercersberg, PA, Member of American Society for Quality, American Institute of Chemical Engineers, Water <br />Environment Federation, American Water Works Association past State of Florida Training Chairman <br />COMPUTER SKILLS <br />• Excel <br />• MS Access <br />• MS Project <br />• DataEase <br />• PowerPoint <br />• WordPerfect <br />• Word <br />• RS /1(similar to SAS) <br />RS /Explore(DOE software) <br />• RS /Discover <br />ADDITIONAL KNOWLEDGE AND EXPERIENCE <br />Working knowledge of statistics. Attended training courses in SPC, design of experiments, statistical analysis of data <br />and quality project management. Troubleshooting of membrane filtration, lyophilization, aseptic processes. Exposure <br />to ANSI /ASQC 090 -94 (ISO 9000 -9004) for quality management and quality assurance standards, MIL - STD -105 AND <br />414 for product sampling, MIL -0 -9858 for quality programs. Extensive experience with Good Manufacturing Practices <br />(GMP's). <br />