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Regulatory/Quality Assurance Consultant Profiles

Dashe & Thomson's regulatory/quality assurance team is supplemented by our database of more than 10,000 independent contractors in cities throughout the U.S.

Here are profiles of a few of the consultants we work with most often:

Quality Assurance Manager/Quality Assurance Analyst
As Quality Assurance Manager for a health care organization, managed QA personnel, developed reporting matrix, defect reports, and project testing results. Authored QA procedures to help ensure overall quality during project life cycle, including Issue Reporting, Escalation, and Tracking; QA Project Life Cycle; QA Standards for acceptable testing results; and Proper Requirements Documentation.

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    • As Lead Quality Assurance Analyst for a financial organization, created Test Plans and Test Cases to verify data constraints. Prepared and executed testing (unit, integration, regression, stress, load, and black box). Developed reporting matrix, defect reports, and project testing results. Responsible for maintaining system metrics and workload assignments for a staff of 6 in the Minneapolis office and 7 in the Bangalore, India office. Maintained all QA database environments (3 environments, 60 databases).

    • As Lead Quality Assurance Analyst for a high tech company, managed team of 5 people and created Test Plans, Test Cases, and Test Scripts to verify data constraints. Responsible for the preparation and execution of testing (unit, integration, regression, stress, load, and black box) using Rational Robot automated testing software.

    • As Data Quality/System Analyst for a medical device company, developed and maintained standardized data models, data dictionaries, modules, code lists, and programmatic data checks. Created Test Plans, Test Cases, and Test Scripts to verify data constraints. Supported and trained Clinical and IS personnel in clinical software applications programs and associated utilities used by Clinical Data Management.

    • As a Lead Database Administrator/ Quality System Analyst for a clinical data management company, supported and trained Clinical and IS personnel in the use of clinical software application programs and associated utilities used by Clinical Data Management. Developed, maintained, and validated clinical databases and associated utilities. Performed data analysis of clinical and laboratory data. Responsible for application and data security.

    • As a Validation Quality Tester for a clinical data management company, prepared test plans and test cases and executed test scripts in accordance with FDA guidelines to ensure clinical applications were handling data correctly. Performed all software and validation testing (including functional, stress, integration, black box, and load testing). Committee member on CDISC (consortium for the standardization of clinical data) and 21 CFR-Part11 (relating to Regulatory and FDA regulations).

    • As a Senior Database Administrator/ Quality System Analyst for a pharmaceutical company, developed, maintained, and documented databases used for and associated with clinical trials. Generated and maintained documentation and security for randomization schedules used in clinical trials. Reviewed, modified, and approved CRFs after comparison against study protocol.

    • UNIX, UNISYS, Novell, VAX, Java, .NET, PowerBuilder; Mercury Test Director, Jira, Virtual Source Safe, Rational Test Manager, Rational Robot, Microsoft Studio’s Team Foundation Server; Microsoft Project, Excel, and Word; SQL Plus, SQL, SQL Assist, Brio, Lotus Notes; e-Research Technologies eDM, eDE, & eSC, DLB Recorder, General Computer Systems (GCS) AFMS, GRANITE

    • B.A., Governor's State University, Park Forest, IL. Dean's List, National Honors Society

Senior Technical Writer/Training Developer
For a brokerage firm, managed contingency plan for delivery of corporate and branch wide ERP training. Developed, implemented, and managed work-around processes related to LMS system. Activities included identifying and helping to implement reporting, resolve issues related to contingency plan, and managing communication with end-users via project email site. Helped developed Support-Desk data base using PB Wiki tool.

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    • For a utility company, developed and implemented Sarbanes-Oxley for Plant Operations. Developed processes, identified control points, conducted testing of controls in the field, and performed auditing. Selected and implemented Certus, a software tool for managing the company’s Sarbanes-Oxley program.

    • For a healthcare company, managed team of instructional designers to design eLearning and instructor-led training for a product lifecycle management software (Dassault MatrixOne). Performed gap analysis to determine communication/training strategy for roll-out, implemented train-the-trainer training, and managed classroom delivery across all sites.

    • For a diversified technology company, performed gap analysis and determined requirements for process improvements for the company’s controlled document management system.

    • For a retail grocery chain, worked with a team of Instructional Designers and Training Developers to design and develop classroom training materials for employee-wide software implementation.

    • For a state government court system, developed documentation and training for new database system. Documentation included online help, policy and procedure guidelines, training materials, and a Getting Started Guide.

    • B.S. , University of Minnesota, Minneapolis, MN. Major: Technical Writing/Communications, with an emphasis in Medical Education.

Senior Business Analyst/ Project Manager
Certified Project Management Professional and Senior Business Analyst with more than 20 years of industry and consulting experience in the information systems field, encompassing the entire development life-cycle. Direct experience managing multiple large-scale projects with large staff, large budget and broad impacts, including enterprise-wide project management offices, e-commerce and internet projects, expense reduction programs, document management systems, strategic information systems planning, infrastructure, methodology enablement and business process re-engineering. Successfully helped numerous organizations enhance their operational effectiveness and customer satisfaction by realigning organization structures, redefining departmental workflows, and technically enabling business processes.

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    • As a Senior Business Analyst for the Office of Academic and Student Affairs at a university assisted in preparing for campus-wide software implementation of scheduling and space management system. Facilitated the Strategy and Planning phase, conducting current state “as is” process mapping workshops. Conducted Project Strategy Workshops and Critical Gap Analysis to determine process improvements. Providing change management leadership. Currently facilitating the Organizational Readiness phase and developing policies, standards, and procedures for the “to be” processes.

    • As Project Manager/Senior Business Analyst for a trust company, leading an effort to effectively and efficiently transition 5 out-of-scope business areas, including personnel and more than 100 processes to new receiving lines of business, as a result of selling the record-keeping segment of the Retirement Services (RS) business. Performed the transition without disrupting service to clients, creating business problems for the client or creating any sort of issue for the transition of the record -keeping business to its new company. Planned, managed, executed, tracked, and reported risks, and issues.

    • As Project Manager/Senior Business Analyst for a consulting company, supported activities for the sixth largest spinoff in U.S. corporate history. Provided support to multiple rebranding work-streams and technology infrastructure separation initiatives across the Asset Management and Retirement Services businesses that included web and non-web applications. This work included establishment of detailed project plans, resource planning, monitoring of tasks, risk management, program management support, identification/resolution/ escalation of issues, development of process, communication, creation of requirements, oversight of business and technology effort, test strategy and test plan development, test coordination, implementation and status reporting. Participated in implementation of a Quality Management System Framework, performed quality control and assurance for all project test deliverables, led UAT.

    • As a Senior Business Analyst for a health and safety division of a public sector organization, defined requirements and design for business process management in the Hazardous Waste and Radiation Protection programs. Synthesized workflow, content management, and enterprise application integration for Response Management system.

    • As Project Manager for a national insurance/employee benefits firm, provided consulting for a growth strategy program to grow group and voluntary insurance businesses with a goal to reach the top five in their industry.

    • As a Project Manager for a major retail organization, helped to manage the corporate intranet. Created and piloted a site-let solution framework to deliver content sites to the intranet. Providing a controlled on-ramp for business groups to get their communication needs met in the intranet. Managed operational enhancements to corporate intranet, and developed bi-weekly enhancement release cycle.

    • As a Senior Business Analyst for a major health care provider, leveraged best practice artifacts, processes, and tools within a RUP and corporate CMM initiative. Provided leadership, mentoring, coaching and analysis to develop business requirement artifacts for an enhanced health care Employer eServices web portal, designed with new features to help improve the customer experience for online benefits administration. Held Design reviews and delivered artifacts including Use Cases, UML Models, Use Case Diagrams and Activity Diagrams, Business Rules, Page Mockup/Wireframes, Navigation Flow/Storyboard, UI Requirements, Glossary and Message Specifications.

    • As a Project Manager for a diversified technology company, provided leadership, project mentorship and project management for a portfolio of projects in support of a Global Electronic Document Management system, to be used in the submission of 3 drugs for a clinical study to the FDA. The electronic document management system will support the entire Global R&D knowledge chain including pre-clinical, clinical, CMC and regulatory as well as post-submission query tracking. Developed a project plan, communication plans and progress reports for a portfolio of projects including more than 60 sub-projects managed resources. Facilitated project assessment activities and prioritization of initiatives.

    • As the chairperson and project coordinator of an internal Project Management Task Force, led a team to develop a Project Management Charter, Project Management Guidelines, Project Management Templates and Project Manager Profile tools.

    • As a Business Dimensional Modeler on a Global Web Reporting Project, provided technical modeling expertise in the area of Business Dimensional Modeling for a data warehousing initiative.

    • Organization Change Management, Six Sigma/SEI/CMM, Project Management Office (PMO) Services, Enterprise Systems Planning, Business Process Improvement, Facilitation, Strategic Planning, Process and Data Modeling, PMBOK, BABOK, Catalyst, RUP, Clarity, Method/1, SEI/CMMI, DMAIC/DFSS/DMADV, Price Waterhouse System Management Methodology of System Design (SMM&SD), JAD Facilitation.

    • B.S. Computer Science/Electronics Engineering Technology, Mankato State University, Mankato, MN; AQMS (Quality Management System) Framework Certification; Project Management Professional (PMP) Certification; Supervision Certificate, Employer Education Services (EES) Carlson School of Management.

Senior Technical Writer/Training Developer
20 years of experience developing a variety of computer hardware, software, medical and training documentation. Experience with writing HTML-based and WWW information, technical brochures, procedures, online help/tutorials; developing training materials and user interfaces.

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    • For an international diversified technology company, developed an Electronic Performance Support System (EPSS) for Enovia/Matrix One Engineering Central and Designer Central.

    • For a manufacturing company, developed training for Enovia/Matrix One Apparel Accelerator. Developed instructor and participant guides, demos, quick reference cards, and work instructions for the EPSS. Responsible for project management and team training.

    • For a medical device company, wrote and updated instructions for physicians on how to program an implanted device and estimate battery longevity. Project involved writing for U.S. and international audiences, working with illustrations, coordinating translations, and following FDA regulations and guidelines.

    • For a product life cycle management company, developed and wrote the installation and configuration and administration guides (over 400 pages) for Windchill Product Data Management (PDM) software interfacing with an SAP R/3 system.

    • For a medical device company, developed and wrote the user manual for a device designed to perform urodynamic studies; evaluated and provided feedback on user interface.

    • For a telemectric device company, reorganized, and updated online help and user manual for data collection and analysis software for implantable telemetry devices in laboratory animals.

    • For a performance management company, developed and wrote software manuals for aerosols, particle, and fluid flow measurement instruments such as spectrometer and refractrometer and applications such as PIV/PLIF. Developed and wrote over 50 hardware and software manuals for a variety of scientific test instruments, including reference, installation, and user manuals, and tutorials. Designed and wrote online documentation and context-sensitive help. Designed user interfaces and tested beta software.

    • For a high tech company, developed documentation for e-commerce applications including API and system administrator’s guides, application notes, HTML help, and white papers.

    • M. A., Journalism and Mass Communication, University of Minnesota; M. A., Journalism and Mass Communication, Osmania University, India; B. A. Literature, Economics, Political Science, St. Francis College, India.

    • Senior Member, Society for Technical Communication (STC); Associate Fellow (2009); Distinguished Chapter Service Award (2006), Merit and Excellence Technical Communication Awards.

    • Software Tools: MS Office programs; RoboHelp, Doc-to Help; Acrobat, Photoshop, Visio, QuarkXpress, FrameMaker, Captivate, HTML applications; variety of software applications including Enovia Matrix One and Windchill PLM applications.