databb
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databb

Expert in: Computers & Programming    
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Languages: English
12+ years exp in Technical documentation within bio-tech industry. Create User Acceptance Test Plans, SOPs, familiar with all SDLC deliverables, IT audits
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Degrees

BS, Information Systems Mgmt Certificate Project Management Univ of Maryland Univ College

My Expert Service

Qualified Business/Systems Analyst with 12+ years of combined IT consulting experience in computer system operations and information architectures within the bio-tech, health-care and financial industries. Experience includes 4-years in Business Analyst roles and 8-years in Systems Analyst role auditing and preparation of computer system validation documentation for enterprise applications. I have a broad understanding of core IT management processes (change management, system development life-cycle, information systems security, and IT operations, etc.). My background exhibits strong diagnostic and analytical skills and the ability to apply my industry knowledge and best practices to strategically analyze and document system effectiveness and deficiencies in a clear, concise manner.

Experience & Qualifications

Business Analyst (Freelance Consultant) American Education Research Association, Washington, DC Nov 2009 to Feb 2011 • Assisted in the preparation of media kits and quarterly presentation materials used for non-profit educational research organization. • Edited scholarly content for reports, articles, book chapters, and electronic media for academia research studies. Business Analyst (Consultant) Johnson & Johnson Healthcare, Piscataway, NJ July 2009 to Nov 2009 • Developed understanding of business requirements while working with business partners, subject matter experts (SME), enterprise architects, and application developers for integration of COTS and custom applications • Created data flow diagrams based on understanding of business needs and application architecture standards using MS Visio. • Created and maintained workflow diagrams using MS Visio to illustrate various system interactions with upgraded SAP applications ( Ethicon, McNeil, and Cordis) . • Translated workflows into business user requirements and functional specs. Systems Validation Analyst (Consultant) Otsuka Pharmaceutical, Rockville, MD Jul 2008 to May 2009 • Authored master validation plans, protocols (IQ, OQ and PQ) and status reports using MS Word and computer systems qualification/validation documentation standards and maintained deliverables using Documentum electronic document management system (EDMS). • Documented systems requirements, performed systems integration and regression testing in agile test environment and validated ongoing changes to various ERP, Oracle, COTS and Siebel systems. • Created and executed validation use cases and provided peer reviews for qualification/validation documents Business Systems Analyst (Remote-Consultant) Bristol Myers-Squibb Pharmaceuticals, Evansville, IN Apr 2006 to Jun 2008 • Served as lead test developer and created user acceptance test plans and/or executed test scripts for data management software (LIMs Sample Manager) upgrade using manual test methods for pilot site located in New Jersey. • Used MS Visio to translate TrackWise workflows into business user and functional requirements. • Performed random vendor audits of manufacturing batch records and monitored quality events and CAPAs (Corrective Action Preventive Action) as part of Quality Management System. System Administrator (Remote-Consultant) Pfizer Pharmaceuticals, Terre Haute, IN Jul 2007 to Dec 2007 • Provided regional user support for electronic document management system EDMS (Documentum) within Quality Operations Group. • Prioritized and resolved incoming help desk ticket to support local and regional users (password reset, user rights, document routing, etc.). • Maintained and audited database users and security roles and created standard & ad-hoc reports. IT Systems Analyst-Lead (Full-time) Control Solutions, Inc., Atlanta, GA Aug 2004 to Jan 2006 • Executed and tested operating effectiveness for financial IT systems and internal controls for Sarbanes (SOX-404) compliance. • Conducted internal corporate audits of various client business (Banking, Retail, Utility, Telecommunication) processes and assessed associated risks, while analyzing impact and made recommendations based on the adequacy and reliability of controls; prepared and documented findings as necessary. • Conducted gap analysis and mitigated project risks with creation of requirements of existing IT and financial controls. . Senior Validation Specialist (Consultant) Research Triangle Institute, RTP, NC Feb 2004 to Jun 2004 • Assisted with preparation of requested documentation resulting from audits and inspection activities of existing documentation. •Prepared high quality reports of audit findings and made recommendations as required.

Available Modes Of Communication

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