SUMMARY:

• Dedicated and accomplished Quality Assurance/Validation Analyst offering over 13 years of experience across software design and development, database design and management, and technical support, as well as providing thorough and skillful support to upper management.
• Committed to high work - ethics and superior customer service. Offering solid time management skills and ability to organize, prioritize, and perform multiple tasks in deadline-driven environments. Proven aptitude for rapidly learning new skills and implementing new processes effectively.
• Project Management Strategic Planning/Analysis Consultative Listening
• Professional Networking Problem Resolution Skills Rapid Learning Aptitude
• Exceptional Communicator Decisive / Ambitious Multitasking/Time Management
• Analytical Thinking Team Building/Management Interpersonal Skills
• Highly Adaptable Highly Organized/Dependable Quality Control Aptitude

TECHNICAL SKILLS:

Test Tools: SQA Robot, Win Runner 7.5 & Load Runner (Mercury Interactive) HP Quality Center (ALM)

Languages: C, C++, Visual Basic v 5.0

Databases: Oracle 7.3, MS Access, Sybase, and SQL

Browsers: Netscape, Internet Explorer

Operating Systems: Windows NT/98, Windows 95-XP, UNIX, MS DOS

PROFESSIONAL EXPERIENCE:

Confidential, Jersey City, NJ

Senior Business Analyst

Responsibilities:

• Administered solid systems analysis utilizing comprehensive Business Requirement gathering, Business Process flow, Business Process Analysis and Modeling, and Project Coordination.
• Performed Object Oriented Analysis and Design (OOAD) and preparation of SIPOC diagrams including Use Cases, Class and Activity diagrams.
• Developed and distributed Business Requirement Documents (BRD), Functional Specifications (FRS), Systems Design Specification, and System Requirements Specifications (SRS).
• Assisted in the development and validation strategy for importing and recording testing and operational data.
• Developed and implemented quality control measures for regulatory, clinical, and data management.
• Created, validated, and executed manual test scripts including Functional Testing, Boundary Testing, Exception Testing, Regression Testing, and Production Readiness Testing.
• Verified functionality for user requirements and functional specifications for multiple modules, including clinical trial data, Confidential t manager, and query responses.
• Collaborated with other computer specialist to ensure the creation of optimum software throughout the software development lifecycle while developing testing plans and coordinating with IT departments for business needs.
• Experience with Documentum and RASS, Sharepoint, TRS eCTDXPress & TSR Publisher - CSC

Confidential

QA Validation Analyst

Responsibilities:

• Functioned as Quality/Validation lead on R&D information technology projects. Authored the following Validation Life Cycle documentation in accordance with Confidential standards and performed Validation testing using IQ/OQ/PQ test scripts.
• Validation Plan, Functional Requirements, Test Plan, IQ/OQ/PQ scripts, Requirements Traceability Matrix, Deviations, Test Summary Report, and Validation Summary Report.
• Led meetings, gathered user requirements and documented in accordance with GxP and company standards.
• Created change requests for the post Go - Live changes for applications using Trackwise and REMEDY.
• Reviewed and approved validation deliverables, change requests, system deviations and incidents.
• Performed vendor and internal auditing for compliance implicated business areas.
• Coordinated the implementations in QA & Production with the service provider for changes after Go-Live.
• Developed a QA program for Information technology projects, including the development of policies and procedures.
• Ensured IT GxP compliance to company s internal practices and 21 CFR Part 11 regulations.
• Led Periodic Review program for all the GxP computerized system, authored SOPs and work instructions.
• Experience with Confidential, Confidential, Confidential
• Created Test Plan, Test scripts, Test Summary document.
• Review all the testing documents (Test Script, Result with Screenshots signatures,Test Summary Report)
• Experience with Documentum and RASS Upgrade project.
• Created Test Plan, Test scripts, Test Summary document.
• Tested with New and existing submissions.
• Review all the testing documents (Test Script, Result with Screenshots signatures,Test Summary Report)

Confidential

Lead Quality Assurance Analyst

Responsibilities:

• Continuously improved operational and compliance procedures within the Clinical Research group to streamline efficiency.
• Performed comprehensive analytics and testing.
• Led cross-functional team to organize QA funcitons and testing with off-shore teams.
• Guided off-shore teams in clinical system UAT processes within specified timelines while successfully completing various study UAT’s using Oracle Confidential Architect and Central Designer.
• Drove teams to ensure timely and accurate clinical testing while verifying test cases, editing check test data, and recording test results.
• Collected and organized testing documents and signatures necessary for meeting compliance standards.

Confidential, New York, NY

Senior Manual Quality Assurance Tester

Responsibilities:

• Created testing plans, developed test summary reports, and recorded and tracked software faults.
• Verified testing results and collaborated with development teams to resolve software defects.
• Reviewed, updated, and approved project deliverable documents such as: Validation Plans, Validation Reports, and SOPs to ensure the compliance of security requirements, disaster recovery, as well as GCP and WW Regulatory requirements.
• Worked on projects for clients including Confidential, Confidential, Confidential, Confidential, Confidential, Confidential, Confidential, and Confidential .
• Experience with Confidential, Confidential

Confidential, Bridgewater, NJ

Senior Quality Assurance Tester

Responsibilities:

• Created, validated, and executed automated test scripts using WinRunner 7.5 as well as manual test scripts.
• Coordinated, reviewed, and compiled audit response documents for Internal - Regulatory quality assurance audits.
• Created and updated the Traceability Matrix to ensure that all requirements were met and remained accessible.
• Verified the functionality with to User Requirements and Design Specification for different modules such as: Clinical Trial Data, Confidential t Manager, SAE Reports, and Query Responses.