Summary of Qualifications
Profound familiarity with Software Development Life Cycle (SDLC), adept in creating design documents, Test plans, Test scenarios, Test cases, Validation Master Plans, Validation plans, Validation test plans, Test protocols, QSR, Risk acceptance, Risk Assessments, GxP, 21 CFR Part 11, URS-FRS-Traceability matrix, Change Control, GxP compliance, Audit Trail, GxP Compliance, Data Integrity, Issue and Deviation Log.
Adept team player known for exceptional communication skills, facilitating seamless collaboration and project success.
Holds certifications as a Scrum Master and ISTQB, showcasing commitment to professional development and industry best practices.
Extensive expertise in automation using Visual Test, Exactor, Selenium, Webdriver, OpenStA, and QTP, streamlining processes and enhancing efficiency.
Developed and implemented eValidator and Selenium scripts, instrumental in validating and verifying the EtQ Reliance system.
Work Experience
Agilent Technology
QA QMS Enterprise Mar 2019 – present
Led TrackWise system implementations, overseeing requirements gathering, test case development, protocol generation, execution, and end-user support, including Data Migration initiatives.
Functioned as the Validation QA QMS Enterprise Lead for Agilent’s Agile PLM implementation, orchestrating CAPA, Complaints, Audits, DHF/DMR, and other modules. Authored Validation Plan, Validation Protocol, OQ and PQ Test Protocols, Trace Matrix, Data Migration Plan, and Final Validation Report summary. Executed test scripts collaboratively with Business users and reviewed vendor-supplied software configuration testing documentation.
Collaborated with Business and End Users to resolve TrackWise system-related issues through system configuration and updates. Investigated and collaborated with SAP developers to resolve system issues.
Led Validation QA QMS Enterprise initiatives for Agilent’s SAP MES, SAP Cloud Service, SAP Field Service Management, SAP GDPR, and SAP ECC, SAP CRM Trading Licenses projects. Authored Validation Plan, Validation Protocol, OQ and PQ Test Protocols, Trace Matrix, and Final Validation Report summary. Collaborated with Business users for test script execution.
Authored comprehensive Data Migration plans, Data Migration test scripts, OQ Protocols, and managed data migration files across all phases, specifically migrating TrackWise System CAPA and Complaint modules to Agile PLM.
Created detailed work instructions for Risk Assessment and the test case writing process using a Risk-based approach, ensuring efficient test case execution.
Ridge Code
EtQ Consultant Jan 2018 – Mar 2019
Spearhead comprehensive EtQ implementation initiatives encompassing system configurations, development of new modules, and providing adept user support.
Contributed to the testing and verification processes for newly introduced changes, ensuring their seamless integration and functionality within the system.
Collaborated with cross-functional teams to analyze requirements, customize configurations, and optimize EtQ modules for enhanced performance.
TekSystem / RRD
EtQ Analyst Jan 2017 – Jun 2017
Proficiently managed EtQ system administration duties encompassing system configurations, development of new modules, and offering comprehensive support to users.
Conducted training sessions and provided ongoing support to both the EtQ team and business users, ensuring a thorough understanding of system functionalities and optimization.
Proactively identified areas for system enhancement, leading the implementation of improvements such as customized views and scripts to streamline operations and enhance user experience.
Played a pivotal role in the testing and validation process, ensuring the seamless execution of system upgrades, along with the validation of Installation Qualifications (IQs), Operational Qualifications (OQs), and Performance Qualifications (PQs) to maintain system integrity and compliance.
Varian Medical Systems Int.
Sr Enterprise Wide Program Analyst Apr 2012 – Jan 2017
System Administration and Development: Spearheaded system configurations, developed new modules, and offered robust user support as an EtQ Administrator.
Validation and Regulatory Compliance: Led validation efforts, creating Validation Master Plans, Test Protocols, QSR, Risk Assessments, URS-FRS-Traceability matrices, and maintained an Issue and Deviation Log. Improved FDA regulatory compliance through the architectural design and development of an ETQ Reliance enterprise application solution.
ETQ Reliance Project Development: Developed, configured, and implemented ETQ Reliance projects like CAPA, Document Control/Archive, and Complaint Handling, aligning them with quality management regulations.
Quality Assurance: Modified, authored, and executed IQ’s, PQ’s, OQ to ensure new ETQ modules and enhancements conform to functional specifications.
Front Porch
Software Quality Assurance Aug 2010 – Apr 2012
Automated user acceptance test using Powershell and Selenium, and Webdriver
End to End testing for Front Porch enterprise system
Excellency Through Quality (ETQ)
Software Quality Assurance Lead 2005 - April 2010
Spearheaded the implementation of XP practices (Agile) within the QA department, enhancing overall efficiency and adaptability to evolving project needs.
Effectively managed and allocated testers to diverse projects, ensuring optimal utilization of resources and timely project deliveries.
21 CFR Part 11 tests on the Reliance System, ensuring compliance with regulatory standards and guidelines.
Software
QA Partner, Selenium, Jmeter, Visual Test, Silk, Quick Test Professional, OPENSTA, Exactor.
Windows 2K, Windows XP, Windows NT, Windows 95, 98, Windows 3.x, DOS, OS/2, MAC, Linux
Knowledge of Computer Viruses, Wireshark
Lotus Notes, MS Access, Microsoft Office 97, 2000, MY SQL, SQL Server 2000, SQL Server 2005, Oracle, DB2
Jakarta-tomcat, Websphere, Weblogic
Education
Los Angeles City College - Computer Science (some college courses) Aug 94 - Oct 96
