BLANCA QUINTANILLA

949-***-****

ad0tl6@r.postjobfree.com · https://www.linkedin.com/in/blanca-quintanilla-36ba2518/

Accomplished software quality assurance expert with over 20 years of experience able to analyze and model requirements and optimize solutions for web-based systems usage and integrations while providing continuous process refinement across multiple facets of Information Technology. Expert in all aspects of the Software Development Life Cycle (SDLC) in Agile and Waterfall Methodology. Promotes a culture of independence, accountability and trust while mentoring junior team members.

SKILLS

CLINICAL TRIALS • MS SERVER • VMWARE SERVER • ORACLE • SQL • .NET • IIS • XML • HTML • JSON • API •WEB SERVICES (SOAP/REST) • EXTRACT, TRANSFORM, LOAD (ETL) • TEAM FOUNDATION • VSTS • TFS • SPRINT PLANNING • ATLASSIAN SUITE• JIRA • JIRA ADMINISTRATION • ALM QUALITY CENTER • QC ADMINISTRATION • TEST TRACK • SHAREPOINT • MICROSOFT OFFICE SUITE • GOOGLE SUITE • POLARION • POLARION ADMINISTRATION • PLANVIEW • BOX • ALFRESCO • DOCUSIGN • PHARMACEUTICAL • 21CRF PART 11 • GCP - GOOD CLINICAL PRACTICES • HIPPA • RANDOMIZATION AND TRIAL SUPPLY MANAGEMENT- RTSM • CLINICAL TRIAL MANAGEMENT SYSTEMS – CTMS • INTERACTIVE WEB RESPONSE SYSTEMS – IWRS • INTERACTIVE VOICE RESPONSE SYSTEMS – IVRS • QUALITY SYSTEMS • CAPA • SOP – STANDARD OPERATING PROCEDURES • SWI – STANDARD WORK INTRUCTIONS • SALES FORCE • SDLC • TEST STRATEGY • TEST PLANNING • TEST CREATION • REGRESSION TESTING • MANUAL TESTING • INTEGRATION TESTING • BLACK BOX TESTING • WHITE BOX TESTING -DATABASE TESTING • GRAY BOX TESTING• IQ – INSTALLATION QUALIFICATION TESTING • OQ- OPERATIONAL QUALIFICATION TESTING• PQ - PERFORMANCE QUALIFICATION TESTING • SCRUM • PROJECT MANAGEMENT • UAT – USER ACCEPTANCE TESTING • AGILE • RISK ASSESSMENT • REQUIREMENT ANALISYS • ISO9000 • SMART SHEETS • ABILITY TO READ MAPPING DOCUMENTS

SPECIALTIES

•Developing software quality standards and procedures

•Understanding agile software development methodologies

•Mentoring soft skills and testing abilities

•Excellent Communication

•Managing geographically spread QA teams

•Recommending and adopting new technologies

•Keeping current with best practices

•Process Improvement

EDUCATION

B.A., BUSINESS ADMINISTRATION (MANAGEMENT) • CALIFORNIA STATE UNIVERSITY, FULLERTON

ADDITIONAL COURSES:

Improving Your Project Management Skills by the American Management Association – 2015

Crucial Conversations - Tools for Talking When Stakes Are High – 2014

Managing Across Cultures – 2014

Lean Six Sigma Yellow Belt

EXPERIENCE

PERSONALIS, INC October 2022 – March 2023

SR SOFTWARE QUALITY ASSURANCE ENGINEER

Work closely with internal stakeholders on ongoing development and continuous improvement of the lab information systems quality process for immunogenics platform.

Generate software deliverables and documentation as per company established processes and procedures.

Participate in software risk analysis activities.

Support CAPA investigations related to the software and product/process issues and ensure proper documentation of the investigation and corrective actions.

Participate in requirements and design review meetings and create comprehensive test strategies/plans.

Coordinate and perform IQ, OQ and PQ and keep proper documentation.

Participate in the Quality-Regulatory meetings and other related activities of the Operations Informatics group.

With guidance from the Quality Assurance & Regulatory Compliance team, participate in the review of software related policies, procedures, protocols, reports, and quality records, as needed.

CLARIO July 2017 – October 2022

TEAM LEAD, SOFTWARE QUALITY ENGINEERING May 2022 – October 2022

Achieved 99% defect free findings after deployment 4 years in a row.

Managed the domestic and international SQA team members in Germany, India, and US.

Led a dynamic team of Quality Assurance Engineer, providing strategic planning, coaching, recruitment, selection, performance development, and mentorship.

Maintained standard operating procedures, standard work instructions and templates.

Conducted reviews of system and documents to ensure high quality deliverables.

Provided strategic direction, trained and mentored the SQA team

Develop, complete, review and maintain all qualification documents required for release, including test plans, test cases, test matrix, and qualification summaries.

Conduct white box, black box, gray box, and integration testing of changes to pharmaceutical clinical trials applications.

Work closely with developers to discuss all possible areas for testing and to contribute to design discussions for those functions.

Assist the delivery team with defect review, risk tolerance, forecasting guidance and help determining critical path decisions.

SR SOFTWARE QUALITY ENGINEER July 2017 – May 2022

Achieved 99% defect free findings after deployment 3 years in a row.

Managed designated staff. Develop and maintain SOPs, SWIs and templates. Conduct reviews of system and documents to ensure high quality of deliverables.

Provide forecasting guidance.

Develop, complete and review and maintain all qualification documents required for release.

Work with Delivery team to define and implement processes.

Serve in a Lead role capacity on projects and releases using Agile and Waterfall methodologies.

Conducted integration testing for cardiac and respiratory device data as well as eCOA data.

Conducted manual application and regression testing in a web environment.

Detect and document defects.

Work closely with developers to discuss all possible areas for testing and to contribute to design discussions for those functions.

Thoroughly document test results (via detailed problem descriptions and complete test reports) to high level of standards of certification (FDA, ISO9000).

Assist the delivery team with defect review, risk tolerance and help determining critical path decisions.

PAREXEL September 2007 – July 2017

PROJECT MANAGER November 2015 – July 2017

Serve as the key operational interface between global clients and PAREXEL a leading CRO (Contract Research Organization).

Responsible for the execution of tasks directly related to the build and live phases of a study.

Provide tactical management and leadership to project teams to ensure client projects proceed on time, within budget and with quality, therefore maintaining and enhancing client satisfaction.

Provide work direction to project team members. Work closely with Production Services, Validation Services. Customer Care, Language Services, Project Associates, Business Development, Client Account Managers, Business Operations, SPSS, Quality.

Ensure delivery of PAREXEL Informatics products and services to clients within expected timelines and budget with quality, including resource planning and management.

Key client contact for the study and manages the client relationship.

Interpreted client needs, documented comprehensive business requirements, and devised solutions for non-standard tasks and queries, ensuring alignment with project objectives.

Identify, manage, and mitigate any project risks, including ensuring appropriate input from all stakeholders, maintaining accurate documentation, and communicating to internal and external parties as appropriate.

Actively participated in guiding and nurturing client relationships, helping to drive a client-focused approach to project management.

Utilize delegation and negotiation skills regarding project tasks, to obtain maximum productivity and team involvement.

Facilitate training for clients as required. Ensure compliance with SOPs and other relevant regulatory body directives.

Assist with departmental strategies and goals, improving processes and procedures.

Translate often complex technical and/or requirement descriptions into language that can be understood by clients to aid in their decision making and understanding of project functionality.

MANAGER, SOFTWARE QUALITY ENGINEERING May 2013 - November 2015

Manage releases with over five global sprint teams completing releases on schedule and ensuring efficiency and consistency across all teams within an agile environment for EDC, RTSM, IWRS and IVRS.

Determine scope and manage the initiative with all staff involved in converting the defect tracking system to Quality Center.

Managed the adoption and transition of HP Quality Center to be used for formal validation and informal Sprint testing.

Served as tool administrator maintaining user profiles and optimizing defect and test workflows.

Improved SQA processes and procedures by implementing workflows and documentation standards.

Assist a collective group with defect risk and prioritization with engineering team. Worked closely with the stakeholders to determine project scope.

Responsible for the delivery of team and personally committed objectives within agreed time scales.

Assisted in the creation and maintenance of Standard Operating Procedures.

Supervised the SQA team is areas of technology, product, processes including career development.

SR SOFTWARE QUALITY ENGINEER September 2007 - April 2013

Serve in a Lead role capacity on projects and releases using Agile software development and Waterfall methodologies.

Develop and maintain Test Plans and release validation documentation.

Conduct white box, black box, and integration testing of changes to pharmaceutical clinical trials applications including e-clinical solutions (EDC, RTSM, Designer, IWRS and IVRS), clinical study designs and database connectors for the.

Apply store procedures in SQL Server in QA environment.

Detect and document defects within the system and software utilizing Test Track.

Work closely with developers to discuss all possible areas for testing and to contribute to design discussions for those functions.

Thoroughly document test results to high level of standards of certification (FDA, ISO9000).

Work independently to run functional, installation, and use case test cases.

Contact this candidate