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Technical Documentation Specialist Resume

Evansville, IN

CAREER PROFILE:

A highly accomplished skilled and talented Business/Systems Analyst with proven track record of providing overall direction to project team and managing client relationships. Experience includes 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.).

CORE STRENGTHS:

  • Possesses more than 12 years of professional IT consulting experience in computer system operations and information architectures within the bio-tech, health-care and financial industries
  • Possesses strong diagnostic and analytical skills and the ability to facilitate, manage and motivate large scale projects and teams.
  • Proficient in generating logical solutions to meet business challenges
  • Team-orientated and excellent communicator

TECHNICAL PROFICIENCIES

Familiar with: Oracle and SAP application development

Operating Systems: Microsoft Office Suite 2007 (Word, Project, Visio, SharePoint, PowerPoint & Excel)

Programming Languages: C++, JAVA, SQL

FDA Regulations (cGMP and Regulated GxP Environments): 21CFR Parts 11,210,211 and 820

Methodologies: System Development Lifecycle (SDLC), GAMP 4, CoBIT and COSO Auditing, Sarbanes-Oxley (SOX section 404), Agile and Waterfall testing

Electronic Document Management Systems (EDMS): Documentum v4.6, HIPAA and FISMA Guidelines, Computer System Validation (CSV)

Automated and Manual Testing: TestDirector / WinRunner, QTP, Quality Center, ValPro/ WinWriter

HTML: IBM WebSphere, IVR / WVR speech recognition applications

Incident Management: TrackWise, Intersolv PVCS Tracker v5.0

Laboratory Information Systems (LIMs): Sample Manager, HORIZON

PROFESSIONAL EXPERIENCE:

Technical Documentation Specialist

Confidential, Evansville, IN

Responsibilities:

  • Meet with customers to determine their needs, gather and document business requirements, communicate with customers throughout the development project to manage customer expectations, resolve issues, and provide project status.
  • Create/Execute test scripts for new application features and add-ons to support business requirements for proprietary customer CRIS (Complaint Reaction & Inquiry System).
  • Author and/or revise Standard Operating Procedures (SOPs).
  • Coordinate project development, implementation and system integrity audits.
  • Run Query Reports using Access and SQL; development of queries to extract data from various systems
  • Maintenance of user accounts, data entry, training, SDLC (Software Development Life Cycle) activities, as well as other administrative and technical tasks to help drive adherence to regulatory requirements and business needs.
  • Generate reports and support reporting processes and testing for SAR (Statistical Analytical Reporting) system. Assemble presentations and document training material for existing applications.

Business Analyst

Confidential, Washington, DC

Responsibilities:

  • Assisted in the preparation of media kits and quarterly presentation materials for non-profit educational research organization.
  • Edited scholarly content for reports, articles, book chapters, and electronic media for academia research studies.
  • Plan and implement of the organization’s strategic goals to improve efficiency and effectiveness amongst staff and research scholars.
  • Compiled documentation and statistical information data for presentational reports.
  • Maintained and updated existing organization’s company-wide intranet and web portal (discussion groups, forms, etc) for use by internal staff and external research applicants and participants.
  • Worked with developers to arrive at a GUI appearance and functionality to support client/user portal while performing automated GUI regression tests against the Alpha and Beta to validate GUI design.

Business Analyst (Consultant)

Confidential, Piscataway, NJ

Responsibilities:

  • 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 (current /future state).based on understanding of business needs and application architecture standards using MS Visio.
  • Served as liaison for various business units to gather requirements and resolve issues for the upgrade of existing ERP system.
  • Created and maintained workflow diagrams using MS Visio to illustrate various system interactions
  • Translated workflows into business user requirements and functional specs.
  • Worked closely with project managers and associated business shareholders and conducted JAD sessions to define objectives for project and ensure SDLC deliverables consistently satisfied regulatory and business needs.
  • Met with the development team to assess the scope of the project, and new features for an upgraded ERP system and outlined the scope, level and complexity of testing required.

Systems Validation Analyst (Consultant)

Confidential, Rockville, MD

Responsibilities:

  • Authored master validation plans, testing protocols (IQ, OQ and PQ) and reports using computer systems qualification/validation documentation standards and maintained deliverables in electronic document management system (EDMS).
  • Performed "Black Box " testing to emulate the intended audience of various applications to assure understanding of the application and its features and functions.
  • Managed change requests, traceability matrix (tracing requirements during implementation), to include acceptance, installation, and deployment of solutions.
  • Documented systems requirements, performed systems integration and regression testing in agile test environment and validated changes made to various ERP, Oracle and Siebel systems.
  • Documented and tested dashboard interface for electronic medical /healthcare web based CRM application used to support clinical and medical sales force automation staff in accordance to FDA and HIPPA regulations.
  • Provided peer reviews for qualification/validation documents developed and executed by core team members.

Business Systems Analyst (Remote-Consultant)

Confidential, Evansville, IN

Responsibilities:

  • Lead Analyst amongst virtual team and authored test cases and/or executed test scripts for data management software (LIMs Sample Manager) using automated and manual testing for sites in Indiana and New Jersey.
  • Created process flow diagrams, and flowcharts for translation of business user and functional requirements.
  • Served as lead quality liaison for 3rd party/contract manufacturers to ensure order fulfillment and resolve quality investigations or system failures.
  • Performed random vendor audits and monitored quality events and CAPAs (Corrective Action Preventive Action) as part of Quality Management System.
  • Tracked defects in feature/function capability and entered into the defect tracking system and communicated to the team.

System Administrator

Confidential, Terre Haute, IN

Responsibilities:

  • Provided Regional 1st level support for Electronic Documentation Management System (Documentum) and Oracle based applications within Quality Operations Group.
  • Prioritized and resolved help desk ticket to support local and regional users.
  • Troubleshoot and performed problem isolation for trouble tickets, and maintained SQL database backups and replications
  • Development of online form for requesting new user account setup which improved departmental dissemination and sharing of user information from previously paper-based procedure.
  • Configured user profile security and access roles; generated standard & ad-hoc SQL reports

IT Systems Analyst

Confidential, Atlanta, GA

Responsibilities:

  • Executed and tested operating effectiveness for financial IT systems and internal controls for Sarbanes (SOX-404) compliance.
  • Audited existing IT security and access controls, business processes, policies, procedures and management reports for effectiveness and sustainability.
  • Conducted internal corporate audits of business 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.
  • Communicated IT control strengths and weaknesses to internal audit team and key business owners; collaborated with internal audit to develop mitigation plans.
  • Applied COBIT, COSCO methodologies to all documentation and remediation efforts.
  • Conducted gap analysis and mitigated project risk with creation of requirements of existing IT controls.
  • Designed enhancement for internal controls such as segregation of duties, production change management, software management, security, and incident handling to ensure system integrity.

Senior Validation Specialist (Consultant)

Confidential, RTP, NC

Responsibilities:

  • Interacted directly with internal departments in preparation of regulatory inspections (FDA/EPA) site visits.
  • Assisted with preparation of routine and complex audits and inspection activities; prepared high quality reports of audit findings and made recommendations as required.
  • Provided induction and/or remedial training for departments supported by QA.
  • Served as a quality consultant providing advice to departments on broader regulatory issues (e.g., equipment qualification, computer validation, etc.)

Project Manager (Consultant)

Confidential, Indianapolis, IN

Responsibilities:

  • Managed small team for large scale remediation project and used influence to drive ongoing improvement of quality and compliance by proactively identifying opportunities for process improvement with the software development life cycle (SDLC).
  • Addressed 21 CFR Part II compliance issues, provided guidance on computer validation requirements of systems
  • Assisted in the development of User Requirement Specifications for new and legacy equipment.
  • Conducted validation risk assessments for software applications and equipment and made recommendations for remediation as needed.
  • Assisted in developing and reviewing artifacts as required for validation, including validation strategies and plans, validation protocols (IQ, OQ and PQ) and SOPs, Project Status Reports and Action plans.
  • Assisted in the creation and execution of validation test scripts and documented test results in accordance with standards using both automated and manual tools.

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