SUMMARY:

Dedicated and accomplished Quality Assurance/Validation Analyst offering over 15 years of experience across software design and development, Computer System Validation (CSV), 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.

AREAS OF NOTABILITY OR EXPERTISE:

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

CAREER HISTORY:

Confidential, Warren NJ

QA Manager

Responsibilities:

• Defining and implementing agile QA process in to 5 different teams developing a suit of application
• Training mentoring QA leads to follow SOPs and best practices
• Working knowledge of FDAand EMEA regulations especially 21 CFR Part 11 and Annex part 11, ICH E2B guidelines, GxP (GMP/GCP/GLP) guidelines, GAMP (GAMP5), Quality Assuranceregulations, and Good Documentation and Good Testing Practices.
• Experience working onvalidation& verification of Web based and Client-Server applications including Regulatory Registration and Submission system (Verity), Pharmacovigilance Drug Safety Systems (Argus and ARISg)
• Managed device testing for Mobile, Ipad.
• Managing day-day operations of QA
• Provide leadership to global teams defining scope, Requirements, Deliverablees, Timelines
• Working with development team on a weekly basis
• Defining Test Strategy and Test Plan for different projects and Risk Assessment
• Expirience with JIRA, Test Rail
• Expirience in creating/reviewing/approving SDLC deliverables like Validation Plan, Validation Summary Report, User Requirement Specification, Design Specification, Test Plan, Functional Specification, UAT and System Test Protocol, Data Migration Plan, Test Scripts, Test Results (Pre and Post execution), Qualification Plan IQ/OQ, Test Summary Reports, Validation Summary Reports

Confidential, NJ

Sr. IT Quality Validation Consultant

Responsibilities:

• Prepare Specification documents, Test Plans, Test Scripts, Summary Reports
• Conduct Tester training and coordinate testing efforts
• Manage study specific validation documents within data management area
• Ensured IT GxP compliance to company’s internal practices and 21 CFR Part 11 regulations.
• Ensure all the deliverables are completed within established project timeline
• Ensure all the tools and programs are developed using standard SDLC methodologies and established standards
• Perform risk assessments
• Ensure all validation activities and processes performed are conducted according to standard operating procedures and GCP
• Expirience Rally Support Magic
• Participated in all phases of Software Development Life Cycle (SDLC) from planning to Go-Live including Requirements, Design, Testing, Reporting, and deployment to Production following good Documentation Practices, Quality Assurance Guidelines, and Company’s procedures, policies, and standards.
• Was responsible for reviewingvalidation deliverables includingValidation Plan (VP), Regulatory Risk Assessment (RRA), Requirements (RS) and Configuration specifications (CS), Detailed Design Documents (DDD),Test Plans, Test Summary Reports, Release to Use Memo andValidation Summary Report from the validation, Good Documentation Practices (GDP), and compliance perspective.
• Was responsible for driving the review/approval of IQ/OQ/UAT/DM testscripts and defects in HP ALM to ensure their approval meeting the project timelines and budget.
• Created, updated and tracked the Trace Matrix (TM) to ensure all the requirements are completely tested and mapping between requirements, design elements and scripts (ST/UAT) is complete and accurate.
• Was responsible for guiding the testing teams to develop validation deliverables in compliance with company SOPs, QRG’s, and Documentation and Testing Best Practices.
• Prepared project status report on daily basis for management and appropriate stakeholders to keep track of the testing activities.
• Coordinated with the team manager for the timely completion of the requiredvalidationdeliverables and testing activities.

Senior Associate

Confidential, Hartford, CT

Responsibilities:

• Performed Manual and automated testing using HP ALM for Web based applications
• Worked in Agile development environment with frequently changing requirements and features’ set.
• Actively participating in scrum meetings, reviews and developing test scenarios
• Review product requirement documents, functional specifications, and Involved in developing test strategy, Test plan and test case documents.
• Interacting with Business Analyst and software developers for bug review and participated in QA review meetings.
• Expirience with JIRA, Test Rail
• Expirience with Data Management, Data Processing, ETL

Senior Associate

Confidential, Raritan, NJ

Responsibilities:

• Review and approval of SDLC deliverables like Compliance Plan, Compliance Analysis, User Requirement Specification, Functional Specification, UAT and System Test Protocol, Qualification Plan IQ/OQ.
• Involved in Review, Pre Approval and Post Approval of Validation Test Script.
• Ensured IT GxP compliance to company’s internal practices and 21 CFR Part 11 regulations.
• Infrastructure Deliverables like Infrastructure Requirement Specification, Qualification Summary Report, SOPs, and Test Summary Report.

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, patient 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.
• Continuously studied, verified, and improved operational and compliance procedures to streamline efficiency, as well as performed comprehensive analytics and testing.Functioned as Quality/Validation lead on R&D information technology projects.
• Authored the following Validation Life Cycle documentation in accordance with FDA 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.
• 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 functions 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 Inform 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.
• Performing all kinds of tests including Black box, White box, UAT, End to End, Integration, Functional, Stress, Regression, System testing, Data Driven, and Performance.

Confidential, New York, NY

Senior Manual Quality Assurance Tester

Responsibilities:

• Essential representative providing proactive input in the testing of electronic clinical data management products and electronic data capturing.
• 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.
• Experience with Medidata CTMS, RAVE