LIMS Oracle backend, Oracle load testing, Oracle with Crystal Reports for website, some DBA for testing purposes
? Established experience in Biotechnology, Medical, Financial, Investment, Internet, Telecommunications, Commercial products, and other industries in business, financial, and market analysis; software engineering; and support.
? Skills in Business Analysis include evaluation and development of proposals for new technologies, products, and businesses; writing business plans; product and market research and analysis; and general business advice.
? Skills in Quality Assurance include 21CFR Part 11; white box, black box, regression, GUI, website, and load testing; test harnesses, plans, and metrics; and Windows, UNIX, and WinRunner automated test scripts.
? Skills in Software Engineering include requirements definition, prototyping, proof of concept, design, interface implementation, quality assurance testing, and maintenance.
? Skills in Manufacturing Quality Control include quality data analysis and statistical process control.
RENSSELAER POLYTECHNIC INSTITUTE
? MBA, Systems and Marketing
? Masters of Engineering, Management Engineering
? Bachelor of Science, Chemical Engineering
Business Analyst and Engineer
10/1982 - PRESENT
? Established experience in Biotechnology, Medical, Finance, Investment, Internet, Consumer products, and other industries in the areas of market, product, and business research and analysis; database systems; quality assurance and software engineering; manufacturing quality; and support functions.
? Developed System Functional Specifications, Installation/Operation/Performance Qualification and Software Installation Qualification protocols for upgrades to 10 instrument configurations in a Quality Control Laboratory at a leading multi-billion dollar pharmaceutical company. Required compliance with the FDA?s 21CFR Part 11 guidelines. Worked extensively with QC Laboratory Manager and personnel, and the Information Systems group.
? Provided general technical support across a broad range of information systems user issues and applications at a leading billion dollar biotechnology company. Projects included correcting problems with the CEO?s analysis system, support and training for SEC document uploads to the EDGAR system, correcting issues with a company-wide daily news and information system, fixing Genetics and Protein bioinformation systems, and converting an Environmental Monitoring LIMS to one following FDA?s 21CFR Part 11 guidelines. Client/server, Novell LAN, HP3000, VAX, MS Windows, Paradox, oracle, SQL, BASIC, and C/C++.
? Developed a senior executive sales and market planning system for a multi-billion dollar company. Data sources included internal sales and support, Dun & Bradstreet, and CitiBank?s Global Reports. Presentations to senior marketing management. Specialized databases, statistical modeling, RS/1, and BASIC.
? Developed a technical stock trading system for a large investment company. Automated stock data downloads to local database. Specialized databases and spreadsheets with built-in statistical analysis routines. Allowed up to 400 investment scenarios. User-defined graphics and print options. BASIC.
? Team member for development of investment electronic messaging, bank reporting, bank strategic planning, and product pricing systems. MS Windows, MS Office, Specialized databases, BASIC, and C/C++.
? Developed SBIR proposals and business plans, and performed business evaluations for venture capitalists.
? Skilled in Quality Assurance for white box (structural) and black box (functional) testing; automated test harnesses; test tools; test scripting (C/C++, Perl, SQL, UNIX, macros); cross platform and regression testing; load testing; test metrics; bug tracking; test plans; software development cycle at all levels, and standards (MIL-STD, ISO, IEEE, 21CFR Part 11). MS Windows, Sun, oracle, and WinRunner.
? Experience and education (MBA, MENG, and BS) gives a good understanding of business from the factory floor to the executive suite.
FOLIAGE SOFTWARE SYSTEMS
Senior SQA Engineer
3/2003 - 4/2003
? SQA test plan and test cases for investment system using Sun, Solaris, Java, oracle, and Sybase.
? Part of about 30% layoff of department when most client contracts put on hold due to state of economy.
2/1978 - 2/1983
? Supervised a 13-person Data Group within the Quality department of Camera Division. Implemented a data clerk cross-training program. Saved $100,000+ in operating costs.
? Supervised a 3-person factory quality audit station that tested camera sub-components.
? Project Lead implementing real-time factory data collection system. Trained all users of system. Specialized databases, Assembler, and BASIC. Saved $250,000+ in implementation and operating costs.
? Quality Engineer skilled in Manufacturing Quality Control. Developed database, statistics, reporting, and process control systems. Developed coding systems for defect and defect analysis reporting. Specialized databases, BASIC, FORTRAN, ANOVA, SPSS, and SAS. Systems saved $200,000+ in operating costs.
? COMPUTER CONCEPTS include Quality assurance and validation [white box, black box, automated, regression, and load (oracle) testing; test harnesses; test tools (WinRunner); test metrics; test plans; Software Requirement Specifications (SRS); Software Design Specifications (SDS); System Functional Specifications (SFS); Software Installation Qualifications (SIQ); Installation, Operational, Performance Qualification (IQ/OQ/PQ) protocols]; RFPs; OOP; standards (MIL-STD, ISO, IEEE, 21CFR Part 11); GUI; graphics; imaging; video; networking; Internet; and SDLC (software development life cycle).
? APPLICATIONS AND TOOLS include MS Office (Word, Excel, Access), databases (oracle, Paradox, Sequel Server, etc), MS Visual Studio, GNU, UNIX scripting, Clearcase, languages (C/C++, BASIC, FORTRAN, COBOL, HTML, Perl, Java, SQL), ANOVA, SPSS, RS/1, SAS, and WinRunner.
? INSTRUMENT SOFTWARE include Shimadzu?s v7.2 (Shimadzu HPLC), Sievers? DataPro v1.03 and DataGuard v2.04 (Sievers TOC800), Molecular Devices? SOFTmax v4.3 and Enterprise v1.0 (Molecular Devices SpectraMAX 384), and Charles River Endosafe?s EndoScan-V v2.07 and Analex? ESign v2.3.3 (Bio-Tek ELX808).
? ENVIRONMENTS include IBM (mainframe, AS400, PCs); HP (1000, 3000, PCs); DEC (VAX, Alpha, PCs); Microsoft Windows (3.X, 95, 98, Me, NT, 2000, XP); Wintel PCs; Apple Macintosh; LynxOS (real-time Linux); UNIX (HPUX, Ultrix, AIX, etc); Sun (Solaris, Perl); and networks (routers, switches, hubs, modems, etc).
? Publications and presentations include a magazine article on implementing software systems, a talk on computer graphics, and discussions about manufacturing quality information systems.
? Elected to Board of Directors of Nassau Gardens COOP.
? Head Hockey Manager at RPI.
? Ward Chairperson to Cancer Charity and volunteer to Scout organizations for donation drives.
? Ran and worked at several concessions businesses.