SUMMARY:

• I am a Business Analyst and Software Quality Assurance tester in the Pharmaceutical and Healthcare industry. Obtained and analyzed business and technical requirements to determine and construct the appropriate solution for the Clinical, Medical, Customer Service, and Quality functions of the Pharmaceuticals industry with internal stakeholders and vendors.
• Demonstrated ability to assemble and lead global and local cross functional project onsite and offshore teams, develop test plans, project management plans and schedules inclusive of milestones and vendors to monitor progress, ensure timely completion of deliverables, testing artifacts and knowledge transfer. Success in leading and creating systems validation processes, ensuring solutions are delivered within the System Development Lifecycle (SDLC) to drive reliability, quality information and timely business decisions.
• Currently, attained the of Competency in Business Analysis™ (CCBA®) from the International Institute of Business Analysis (IIBA™), achieved the CTFL - Certified Tester Foundation Level from the ISTQB - International Software Testing Qualifications Board and received the Masters in Business Analysis from Villanova University to gain and retain skills that initiate, manage and successfully close IT projects.
• Requirements Management and Communication
• Liaison, Team Leadership and Influencing
• Requirements Elicitation
• Process and Data Modeling
• Pharmaceutical Industry Knowledge
• Project Planning and Monitoring
• Analytical Thinking and Problem Solving
• Vendor Relations
• Software Validation and Verification
• Applications and SQL

PROFESSIONAL EXPERIENCE:

Confidential, Fort Washington, PA

IS Project Manager & Validation Engineer

Responsibilities:

• Implemented a global SAS system by assisting the business owner to create and finalize the project management plan, functional and non-functional requirements and the validation test plan. Created and finalized the system design and configuration documentation with the technology lead. Created the traceability matrix. Led and participated in the validation team in the creation and execution of the installation qualification test plan, test case, traceability matrix, operational and performance qualification test plan, test case and related user acceptance test (UAT) scripts. Created and finalized the validation summary report with the stakeholders.
• Implemented an eLearning (SaaS solution) system by assisting the team to finalize stakeholder requirements, create the system design and configuration documentation. Led and participated in the validation team responsible for creating and executing validation traceability matrix, test plans (I/Q, O/Q and P/Q), user acceptance test (UAT) scripts and wrote the validation summary report.
• Created SOPs for the process improvement of Global Information Services department, specifically the change management, project initiation, project planning and computer system validation (CSV) processes which include departmental, regulatory requirements and industry (information technology and project) best practices.
• Reviewed SOPs for the Global Information Technology department for the installation and maintenance of a virtualized computer environment using the VMware product.
• Provided application development and support including the creation and execution of change controls and regression testing for all the regulated computer systems of Clintrial, Oracle Argus and eLearning.
• Supported the change management process by reviewing individual change controls, creating and reviewing user acceptance test (UAT) scripts, and maintaining the log of approved change controls and participating in the execution and management.
• Supported the project manager of a payment tracking system developed in Microsoft SharePoint by creating and finalizing the project management plan, eliciting business and stakeholder requirements and creating the validation test plan, test case. Created and finalized the system design and configuration documentation with the technology lead.
• Supported the evaluation of a submission management system in arranging an on-site environment, attending and documenting the from the vendor, and documenting and resolving issues from the evaluation.

Confidential, Princeton, NJ

Project Manager, Global IT

Responsibilities:

• Released an upgrade to the safety tracking and reporting system (GCSAE/ARISg) into production with the desired quality and compliance with the FDA 21 CFR Part 11 regulation by assembling and leading a cross functional global onsite and offshore team representing Global IT, R&D, QA and the vendor. This project developed the team's project management, HP Quality Center and validation skills enabling an internal audit of the validation package to pass.
• Spearheaded a cross functional global team representing Global IT, R&D, and QA in the release of procedure and application to electronically submit backlogged safety data to the European Medicines Agency (EMEA) within the GCSAE/ARISg into production. Received an from project sponsor.
• Led and mentored a first rotation Information Management Leadership Program (IMLP) candidate to plan and negotiate the requirements developing a Learning Portal and a Library Subscription Service for Medical Diagnostics Global R&D with GE Corporate IT and the Research Center.
• Installed hardware and software infrastructure required for the E2B Gateway module of the GCSAE/ARISg by negotiating purchase and receipt with internal and external suppliers under direction and in consultation with various global IT managers and using established Global IT process and procedures.
• Generated operational excellence scorecard, which summarized monthly performance, cases, highlights and future activities for Medical Diagnostics R&D applications to the CIO, Medical Diagnostics by consolidating, creating and presenting monthly results from application development and support and project teams. This enabled senior management to analyze results and make critical business decisions.
• As a part time student achieved a 3.67 GPA overall and thesis addressing electronic health records (EHR) entitled "Medical Practice Management.
• Provided application development and support which included the creation and execution of change controls and regression testing for the global R&D computer system of ARISg, Oracle Clinical, SAS and Documentum along with Microsoft Access applications for clinical trial management.
• Implemented bug fixes and enhancements that led to the simplification and retirement of local applications during the integration with the GE network.

Confidential, Princeton, NJ

Sr. Application Developer

Responsibilities:

• Delivered the SAP 3.1i upgrade validation package and production support SOP for process improvement in compliance with appropriate standards, according to plan, on-time and under budget by creating validation traceability matrix, test plans (I/Q, O/Q and P/Q) and test script templates along with supervising the creation of user acceptance test (UAT) scripts. received from project sponsor.
• Released legacy R&D applications into production on a new computer infrastructure as the Project leader and team member responsible for development, testing and migration.
• Ensured consistent cross functional communication and planning by recording and distributing SAP 3.1i upgrade project meeting minutes and maintaining and publishing the action item’s list.
• Enrolled in the Masters in Sciences, INFORMATION TECHNOLOGY LEADERSHIP program at LASALLE UNIVERSITY, Philadelphia, PA and attended classes when able.
• Mentored new R&D application development and support staff in technology, change management and business processes.
• Provided application development and support which included the creation and execution of change controls and regression testing for the global R&D computer system of ARISg, Oracle Clinical, SAS and Documentum.

Confidential, Princeton, NJ

Information Scientist, Information Technology

Responsibilities:

• Created multiple on-site application evaluation environments in development and support of the Wisdom project. Scheduled, created, conducted and documented the evaluation environments involving several vendors and a global cross functional team from the Pharmacovigilance, Clinical, Information Technology and Quality Assurance departments.
• Evaluated, implemented and validated a global computerized system supporting the R&D Pharmacovigilance and Clinical departments within a global cross-functional team.
• Provided infrastructure and application development and support to the local and global R&D applications, and mentored development and support personnel on specific technologies and procedures.
• Supported the project manager in the creation SAP upgrade validation package with responsibility for the Validation Strategy, user acceptance test (UAT) script template, the Operational Qualification plan and summary, and the Validation summary.
• Delivered 11 SAP user acceptance test (UAT) scripts by leading an IT team and a group of subject matter experts.
• Released the ARISg application into production by organizing and leading a cross functional team to create, execute and summarize end user testing supporting a datacenter relocation.

Confidential, Wayne, PA

Associate Information Scientist

Responsibilities:

• Developed, tested, released and supported two applications according to the system development life-cycle (SDLC).
• Identified, separated, restored, and tested Clinical applications within a team environment during the divestiture of Sterling Winthrop to Sanofi Winthrop and Nycomed according to established standards and guideline.
• Provided application support which included the creation and execution of change controls and regression testing for the R&D computer system of ARIS and Clintrail.

Confidential, Collegeville, PA

Programmer/Analyst 1, Information Technology

Responsibilities:

• Developed multiple clinical and laboratory data management processes, applications and end-user technical development and support in Clintrial.
• Developed and led application sessions.

Confidential, Philadelphia, PA

Installation and Modification Engineer

Responsibilities:

• Held a SECRET level clearance.
• Installed land based and ship base systems and provided end-user technical support.
• Developed and led application sessions.