SUMMARY

• Results oriented professional with over 15 years extensive experience in the Pharmaceutical industry in the areas of computer systems validation, business analysis and technical writing. Strong working experience in a FDA regulated environment along with knowledge of the SDLC process. A fast learner capable of handling multiple assignments with demonstrated communication, problem solving and analytical skills. Able to work effectively within all levels of an organization.

TECHNICAL SKILLS

• Agile, CDR (Clinical Data Research), Rater Station, Seapine Software (Test Track), JIRA, Confluence
• EDM - Electronic Data Management, SAP ECC 6.0 & Portal, EtQ Symphony, Cognos, HP Quality Center 10.0
• HP ALM, ERMS - Electronic Records Management System (OpenText), GxPharma, Documentum, TrackWise
• SharePoint, Taleo (Global Applicant Tracking System), MS Excel, MS Word, Vantive, Peregrine
• GroupWise, MS PowerPoint, MS Project, and MS Outlook.

PROFESSIONAL EXPERIENCE

Confidential, Wayne, PA

Senior Project Consultant

Responsibilities:

• Provided quality validation skills and knowledge as part of the QA Validation group supporting Lab Information Management Systems, primarily Empower and NuGenesis
• Performed root cause analysis and evaluation on IT system investigations and CAPAs
• Applied data integrity recommendations for Data Integrity remedition activities
• Provided user support for the TrackWise system
• Submitted requests on behalf of the users for access to TrackWise and modifcations to exsiting accounts
• Monitored the group inbox to ensure that the user’s needs were being addressed

Confidential, Chicago, IL

Test Engineer

Responsibilities:

• Authors test scripts for multiple Clincial Trial systems
• Maintains and executes automated test scripts for assigned projects
• Participates in daily scrum meetings to discuss project issues, daily accomplishments and future assignments
• Peer reviews test scripts to ensure coverage of user stories
• Works closely with Product Innovicatin (PI) staff to formulate the high level testing solution
• Responsible for ensuring that the testing strategy includes complete coverage of requirements and the business process
• Manages testing defects and reports testing status to project teams
• Suppports User Acceptance Testing (UAT)
• Reviews IQ,OQ and UAT testing results to ensure quality adherence to SDLC processes
• Tracks issues and resolutions throughout the testing process
• Documents traceability between testing and system requirements

Confidential, Wayne, PA

Senior Validation Engineer - EtQ and Cognos

Responsibilities:

• Authored the change control for a software interface project between SAP and the EtQ Investigations module
• Addressed QA’s comments on the test scripts for several IT validation projects
• Managed the testing effort performed by the testing team
• Managed the Test Event Reporting process for test script deviations and assisted in the resolving of deviations
• Authored validation documents including Functional Requirements, Traceability Matrix and Production Release Memos

Business Analyst - Records Management

Confidential

Responsibilities:

• Led and coordinated meetings with the Technical Application Owner to gather information required for the decommissioning of Consumer and Medical Technology applications
• Initiated communication with the Technical Application Owner regarding the application to be decommissioned
• Reviewed the forms submitted by the TAO for completeness and accuracy
• Tracked the progress of the decommissioning status
• Worked with the Legal team to assess the the legal status of the applications and participated in meetings with the Legal department
• Involved with requirements, compliance, testing and documentation activities in the Software Development Lifecycle (SDLC) for validated systems
• Created System, OQ and Production Verification test scripts
• Dry ran, edited and reviewed test scripts authored by other team members
• Managed the Test Event Reporting process for test script deviations and assisted in the resolving of deviations
• Peer reviewed executed test scripts
• Authored validation documents including a Traceability Matrix and Document Index
• Authored System test scripts for the Cognos reporting system of EtQ which included: Annual Product Review for Change Controls, Annual Product Review for Investigations, Business Continuity Plan for CAPA and Business Continuing Plan for Investigations.
• Addressed QA’s comments on the test scripts
• Assisted with the execution of the test scripts

Confidential, King of Prussia, PA

Senior Validation Analyst - Global Application Tracking System

Responsibilities:

• Interacted with the project SME to gather requirements for UAT test scripts.
• Authored various validation documents including a Validation Plan, Traceability Matrix, Validation Report, and UAT test scripts
• Collaborated with the project SME to identify system issues
• Trained testers at various global sites on the defect management process in Quality Center and test script execution procedure
• Assisted in the resolving of system defects encountered during testing
• Authored Integration, OQ, UAT and PQ test scripts for a labeling and packaging integration system between SAP and EDMS
• Authored Integration and OQ test scripts for a SAP Packaging Solution using HP Quality Center
• Coordinated and led the PQ testing effort
• Interacted with the Business users to determine their requirements and wrote test scripts to test this functionality
• Involved with troubleshooting and working with the developers to resolve system issues