SUMMARY:

For the past 17 years, I’ve been a Sr. QA/Val Analyst leader with a unique blend of strategic planning and implementation skills that allows me to deliver efficiency with complex global standard. A personable, trilingual Quality Assurance Analyst with a background and expertise in analytical activities. Adept at processing large amounts of data into clear concept reports, detailed and quickly adapts to any challenge that project phase faces. Mediated migration and implementation of multiple, large and complex strategic project tasks from a lead tester to Sr. Validation/QA lead with tech adherences. Managing IT supply chain, CSV - validation for labeling and user requirements, verification for quality and automation process. CSV projects followed the full Systems Development Lifecycle (SDLC) methodology using a risk based approach according to ISPE GAMP5 nd Confidential expectations. Parafino is well-versed in best practices across functional on requirements analysis, design, and implementation to personnel Validation/QA training technique methods, to further business logic continuity goals. Enjoy the added challenge of picking up team transcending test activities, like test coordination, test management, and test architecture. Picks up test automation activities and challenges teams to participate in test execution through exploratory testing, and make actionable recommendations. Am proficient with productivity of 365 tools such as; Visio, Excel, PowerPoint, Word, MS Project and SharePoint, Steps for Accurate and Artful Self-Definition. Fluent in English, Spanish, and Portuguese.

CORE SKILLS:

Agile | Dataflow Testing Technique | Environment | Integration Testing | Scrum | System Testing Test Design | Performance Stress Test Case Development | UAT (User Acceptance Testing) Microsoft SQL Server 2008 | Process Cycle Testing Technique | Test Architecture (Framework) Use Test Cases | Defect Management | Final Project Summary Reports

PROFESSIONAL EXPERIENCE:

Confidential

Technical Specialist (Val)/QA Analyst

Responsibilities:

• Demonstrated the ability to interact with all disciplines across functional organizational, managed and reviewed/Resolutions Recap and closure aligned with cGxP regulations, oversaw project team in all aspects of the validation deliverables in (CSV). Liaison between businesses logic (business users and stakeholders).
• Functioned flexible as SQA Analyst, performed analysis of automation testing efforts and process flow reviews.
• Participated in technical review of project deliverables including requirement specifications, functional designs, technical designs, and other project documentation to ensure testability of requirements and 21 Part 11 Electronic Records/Electronic Signatures (ERES) assessments are met.

Confidential, Sunnyvale, CA

Sr. Val Lead Manual/Automated Test Consultant

Responsibilities:

• Identified areas of development, assessed performance against objects and discussed on best defined approach for testing.
• Collaborated with a development team at Confidential and the test team in Sunnyvale on in-depth and technical test set-up of Invenia ABUS (Automatic Breast Ultrasound System) against the product specification with View Station and Use Analysis.
• Performed top-level traceability of Invenia ABUS-Gen2 System feature implementation, a device intended for Breast Screening use and diagnostic breast imaging. It compares the implementation to the design inputs of product specification for validation testing done against the requirements for ABUS - Pro Gen-II system of MRD and MRS ABUS View Station.
• Reviewed the Invenia ABUS requirements; evaluate by Hardware, Software and system Verification Test groups. V&V results were described in the system and software test procedures and reports.
• Develop, Review and Approve Process Validation procedures and documentation for Computerized System Validations (CSV) for the development
• Conducted the biological Evaluation of Invenia ABUS Medical Devices for vitro cytotoxicity irritation and sensitivity overall the product scope in compliance with the EU RoHS directive as well as International Electrotechnical Commission (IEC) and CFR Part 11/820. The scanner design, including the articulating arm presents no hazard to operator, patient nor bystanders.
• Ensured the Proc Acoustic and thermal output measurements with ABUS-Pro system met the test plan. The testing of Invenia ABUS has achieved adequate breast compression and avoided motion artifacts, and fulfilled the viewing angle greater than allowed vertical and horizontal degrees.

Confidential, Elyria, Ohio

Software Quality Engineer

Responsibilities:

• Focused on validation Framework on the technical reviews of project deliverables, including requirements qualification specifications analysis for VMTrumpf automation testing efforts on Private Cloud client and process flow. Participated in the technical review of project deliverables documentations to ensure testability of requirements 21 Part 820 assessments were met.
• Iterated with the stakeholders in Software Quality Assurance processes practices, and business application functionality.
• Exercised within GAMP5 standards principles as per defined of Quality Management System (eQMS), Computer System Validation (CSV), Computer Application Validation Assessment (CAVA), Project Plan Report (PPR), Validation Plan (VP), System Requirements Specifications (SRS), URS/FRS, IQ/OQ/PQ test scripts, Test Log, Trace Matrix (TMx) and Validation Summary Report in V-Model.
• Developed Project Plan Schedule in MS Project, authored of manually executed validation deliverables of Medical Devices for the following deliverables documentations; CAVA, PPR, VP, SRS, Combined URS/FRS, IQ/OQ/PQ, TMx, Test Log, and Val Summary Report. Setting up testing Trumpf client and audited tests.
• Performed reviews/revisions and updates of Post-Reviewed test cases, Pre-Approvals, reviewer of Post-Executed test scripts, Defect Closure and Post-Approvals, Traceability Matrix and project forecast, ensured project Open-Issues are discussed and resolute. Liaison between the businesses objective (business users and stakeholders).
• Demonstrated the ability to interact with all disciplines across functional organizational, managed and reviewed/Resolutions Recap and closure aligned with cGxP regulations, assisted project team in all aspects of the validation deliverables in (CSV); Requirements compliant, reviewing of system test and test procedures in QA Methodologies.
• Updated Traceability matrix and wrote Val. Summary Report of Software Development Lifecycle, elaborated validation deliverables Corporate/IT SOP cross-referenced in FDA/GMP manufacturing guidelines Industrial standards to ensure System Security Risk Mitigation & Controls Vulnerability.
• Accomplished project tasks closure without supervision and addressed written and verbal communications across functional and recommendations and ability on handling multitasks.
• Feedback from the test manager: "independent, good in coaching, team player, honest and clear communication".

Confidential, Lake Forest, IL

Sr. QA Lead

Responsibilities:

• Functioned as SQA Analyst and performed analysis of automation testing efforts and process flow reviews.
• Participated in the technical review of project deliverables including requirement specifications, functional designs, technical designs and other project documentations to ensure the testability of requirements and 21 Part 11 Electronic Records/Electronic Signatures (ERES) assessments are met.
• Focused on SQA Analysis and the stakeholders in Software Quality Assurance processes on demand best practices, and business application functionalities.
• Exercised within GAMP5 on ISPE standards as per the defined in Quality Management System (cQMS), Computer System Validation (CSV), Test Scripts reviews; System requirements, Design Documents, Implementation Plan, Disaster Recovery Plan, Test Plan, System Functional Test, UATs, Test Log, Test Summary, eQDMS, Validation Summary Report, Validation Certification, Reviewed and revised Test Scripts/SOP.
• Participated with (HPQC/HPALM) test scripts mapping into HPQC/HPALM, test scripts reviews, Pre-Approved test protocols, reviews of test result and Post-Approved test protocols.
• Supported Validation testing team on SAP-ECC repository DBA • HPQC/HPALM and managed R&D in the SharePoint digital data repository. Reviewed and updated discussed Open-Issues, Liaison between the business rules (business users and stakeholders).
• Iterated with all disciplines of the IT organizational and stakeholders meetings Onshore/Offshore testing team process in spite time-zone challenges.
• Managed Defects and reviewed /Resolution Recap and closure, aligned with Confidential regulations a cGxP (cGDP), and oversaw the project team in all aspects of the validation deliverables in (CSV); Requirements, compliance Change Request, reviewing of system test and test procedures in QA Methodologies.
• Updated Traceability matrix and wrote Val. Summary Report of Software Development Lifecycle, and elaborated in validation deliverables Corporate/IT SOP cross-referenced Confidential guidelines Industrial standards in GAMP5 on ISPE to ensure Enterprise Security Risk Mitigation & Controls Vulnerability.
• Performed assigned tasks without supervision and addressed written and verbal communications across functional and recommendations and ability on handling multitasks.

Confidential, Vernon Hills, IL

Sr. Val. Lead Support

Responsibilities:

• Mediated migration of multiple, large, complex strategic project tasks. Participated on the Framework on technical reviews of projects deliverables including requirements specifications, functional designs, UIs and other project documentations compliance to ensure the system testability of requirements meet the project scope.
• Functioned flexibly, scheduled the project track progress onshore/offshore, and remotely.
• Per project phase demand, I traveled internationally onto client’s site, onto Morelos, Mexico and Cali, Colombia to ensure completion of components testing were executed and tested properly.
• Focused on Automation testing efforts, drafted implementation plan strategy and updated revisions of test plan, test sets mapping into HPQC-10/TestDirector; managed Pre-Approved of test scripts and test sets, exercised within global GAMP5 on ISPE standards and Post-Approved test sets onto digital Electronic Document Management System (cEDMS).
• Supported Latin America (LATAM) region Conversion on JD Edwards EnterpriseOne ERP various Modules-Finance, Sales, Ordering Management, Logistics, WMS & Homecare on TeamCenter digital data repository routed system. Used SharePoint DBA for ongoing development such as Change Control, Open-Issues, Project Team Discussions repository were innovation & Global Quality is a standard.
• Served as liaison to the businesses objects needs (business users and business logic).
• Planned framework scheduled and coordinated teleconferences meeting onshore/offshore with the regional project team on open-issues and resolutions. Managed Defects reporting process on HPQC Defect Module, and incident resolved for re-execution. Ensured approved defect for closure and Post-Approved Test Results, are in aligned with global cGDP such as; Comisión Federal Mexico, and Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) Colombia.
• Complied with validation plans system test procedures of user acceptance for IQ/OQ/PQ/UAT) on QA Methodologies, for Colombia and Mexico standards of (21 CFR Part 11, 210, 211, 820).
• Updated traceability matrix (TMx) and final test Summary Reports of Software Lifecycle, and elaborated validation deliverables for Regional Corporate/IT SOP cross-referenced guidelines and Industry standards (GAMP5 on ISPE) ensuring Enterprise Security Risk Mitigation & Controls Vulnerability.
• Excelled in written and verbal interpersonal communications effectively with the project team, and communicated with the project stakeholders and senior leadership across functional organizational to address issues that impacted the projects if any in both; English and Spanish languages.
• Interacted with all disciplines of IT organization and Business Function partners remotely in Colombia, and Mexico projects simultaneously, provided weekly project report forecast, ensured project deliverables closure and quality of data integrity are met.

Confidential, Philadelphia, PA

Sr. Val. Lead/QA Analyst

Responsibilities:

• Validated BioAnalysis (BA-ELN) eLaboratory Notebook, Labware on LIMS and Packet Tracker Application (PTA) a digital data repository for IT/QA, production testing. Performed testing on the instruments for data acquisition and R&D data management and Disaster Recovery Plan procedure,
• Engaged on the Risk Assessment classification and class be plotted against likelihood or probability of detection, governance for controls of Data Privacy, Integrity & security adherence, Cyber law and updated Internet Explorer settings to acceptable version.
• Recommended where necessary compliance manner - achieving qualification / maintenance/systems, for - Project Deliverables Lifecycle Management/ Corporate/IT SOPs, standards.
• Enterprise Asset Management software (Infor10-EAM). The Software as a Service (SaaS) and SharePoint for Lab testing including medical device data values via existing 510(k) records. Scheduled to track progress onsite and remotely.
• Identified and Defined CSV Requirements, Analyzed and Conceptual design/ Overall deliverables solutions, monitored various control systems, Incident & Change Managements Physical & Logical Access Control Systems on Pharma Domain Regulatory Compliance.
• Assessed compliance and reviews of the following: Overall Solutions designing for enhancements testing and configurations testing for projects & service delivery aligned with the applicable regulatory compliance, and managed electronic documentation management systems (EDMS).
• Initiated Framework deems appropriated and applicable regulatory requirements - ISMS, SOX for support, led the project team for deployment and maintaining the systems through maintenance procedure. cGxP 21 CFR Part 11, 210/211/810/820.
• Flexibly scheduled and tracked progress, I traveled onto client site per project phase demand to ensure completion of components testing were executed and tested properly.
• Smith and Nephew, Sao Paulo, Brazil. Manually tested and deployed TOTVS, on Private Cloud standalone domain for Medical Devices in a Pharma environment, used ISPE on GAMP5 global compliance standards. Flexibly, scheduled and tracked progress onshore/offshore, as well as onsite per project phase demand and remotely. I Traveled Internationally on client site, Sao Paulo, Brazil to ensure completion of components testing were executed are tested properly.
• Spearheaded on a technical risk assessment, drafted Test Plan Strategy, for Global Software Lifecycle Management in compliance cross-referenced based on ANVISA for Brazilian (FDA) counterpart for both Components/Cloud Computing guidelines on a Pharma Medical Devices compliance.
• Led the project team in all aspects of the validation deliverables on (CSV); Requirements, Functional/compliance/validation plans, test protocols, Design Specs, Change Control/Amendment, reviewing system test and user acceptance test scripts such as; IQ/OQ/PQ/UAT) Test procedures in QA Methodologies. Liaison between the business continuity, business users and sponsors.
• Traveled internationally on client site, onto Mississauga, Ontario, Canada to ensure the gathered documentations and components of Health Canada cross-reference are in compliance.
• Audited clients SOP for management interacting and managing the internal and external audits in a compliant manner providing support for regulatory audits and audit log.

QA Analyst compliance

Confidential, Lake Zurich, IL

Responsibilities:

• Gathered system requirements and analyzed the specifications provided, enrolled patients for eClinical trials summaries of UATs; Subject summary, Patient visits summary, Patient in visit calendars, patient follow ups summary.
• Set up and run in DATATRAK web based application for eClinical trials testing of patient graphic reporting, querying statistical data reports, graphic reports by race demographic for; area charts, Line charts, scatter charts, bar charts, column charts, gauge reports, timeline graph and pie charts and percentage test results.
• Created DataPoint reports for; review properties in ogress properties, completed properties, frozen properties, signed properties.
• Registered patient log combination in the integration Forms for Screening Patient Visit; Patient Hospital Visit, Patient Vital Signs, Patient Medical History and Patient Visit Info, modules.
• Tested and followed up patients visit vital signs; sinus check, functional check, physical exams, ventricular check, pacemaker check, conduction check, morphology check.
• Example of 36 health survey questionnaire; (i.e) Patient Study termination summary, Patient drug administration summary, Patient medications summary, Patient protocol deviations summary and Patient adverse event summary.
• Tested script container; Syno testnyms summary, branch test, tracing quality assessment, Heart rate (beats), Rate/intervals/Alerts/ rhythm, Myocardial infarction, Myocardial Injury, Infarct pathology and marked depression.
• Executed Lab summary; Serum assessment, hematology assessment, Urinalysis assessment, laboratory results summary. Used Bugzilla Bug-defect reporting tool, and tested test cases and performing testing of the application as per the SDLC methodology.
• Regularly meet with client for interaction regarding the project status and finally deliverables of project summary reports.

Confidential, Waukegan, IL

Sr. QA/Lead Val. Analyst

Responsibilities:

• Plan/UI/DI, including medical devices in R&D data values via existing 510(k) records.
• Charged with Authoring Protocols, Reviewing Protocols, Updating Protocols, analyzing test specs, UI-User Interface verifications
• Design Review interface, executing protocols and Peer-review and Managed Electronic Document Management System (eDMS).
• Understood the concept of Business Process for the core of ENOVIA Software testing, as Service (SaaS), and involved in a fully Internet Explorer upgraded and Enhanced. iQ-Core validation system test, responsible for Traceability Matrix, and complaints Module product evaluation testing, tested Abbott AAH-Animal Health Complaints Module, Abbott Nutrition (AN) testing, Devices Complaint testing, Inventory testing, Abbott Diagnostics (ADD) Integration testing, Customer Complaints Module testing, Validating - iQ Core of ADD Returns and Product Evaluation (CMS), ADD Medical Evaluation and eSubmissions testing, Electronic Medical Reports for MDR, MDI,
• QA w/ QTP testing tool on web application a client server applications testing, XML schema validation solution, Defect Tracking, Incident Reporting and Global compliant on 21 CFR Part 11 FDA/EMEA compliance.
• Attended and participated project team meetings in application software vendors along with clients across functional sponsors.
• Spearheaded weekly project forecast regularly for client interaction regarding the status.

Confidential, Lake Forest, IL

Sr. QA Lead/Val. Analyst

Responsibilities:

• 5 plus Years as a Sr. SQA Lead Engineer were I performed and led testing of multiple, large, and complex projects. Often encountered challenges on strategic of software development applications using SQA testing best practices and frameworks. Reviewed and updated discussed Open-Issues. This role provided appropriate and timely status, metrics and communication to stakeholders.
• Understanding of object oriented concepts and principals on SDLC (Software Development Life Cycle) including: requirements gathering, analysis, design, development, change request process, change control process, contemporary testing methodologies, deployment of change management, decommissioning Phase processes including implementation scheduling, were oversaw in installation and configuration of Validation Certification, Spearheaded migration of multiple projects.
• Responsible for drafting Val/QA Business master templates, QA assessment for infrastructure testing, developed IT/SOP for Val/QA/SOP guidelines, Coached and mentored Validation/QA testers, Analyzed (DQ/(IQ)/(OQ) complete with inspection PQ.
• Developed and maintained Trace Matrix (TMx) updates according to the IT/ Corporate SOP guidelines. Managed, coordinated and executed aspects, of Offshore and Onsite project team members.
• Ensured deliverables were within the established time commitments, and quality by coordinating project teams/resources Onsite and Offshore focus on the projects.
• Led and participated efforts on implementing the COTS Off-The-Shelf customized projects and enhancements, as well as test planning initiative for full-blown testing.
• Audited and inspected projects milestones pre-deployment unto production, ensured safety measures in projects operation is standard. Prepared documentations and records for project deployment and certification report summary.
• Adapted best practices framework assuring a level of systems readiness of test results in accordance with validation SOPs/cGDP standard and (cEDMS), on CFR 21 Part 11 - Electronic Records and Electronic Signatures (ERES) for the following software as well as Disaster Recovery Plan procedure:
• MS Dynamics, Planned implementation and scheduled development for project, ensuring QA requirements projects of SDLC are met. Reviewed batch records and necessary data, test cases/test sets user requirements interface are running the application effectively.
• Confidential, an a logistics warehouse management application, including enhancements modules, implemented schedule and deployed onto production.
• CSOS -Led implementation for integration of CSOS onto MS Dynamics/ Confidential, test sets execution efforts and strategized module/functions on the; Microsoft Dynamics and ASCTrac an (warehouse) logistics applications execution schedules of validation protocols for Controlled Substance Ordering System (CSOS), PharNet a Web Application test cases for Web apps and wireless barcode scanners application.
• Wireless Barcode Scanners,-validated and verified the radio frequency identification (RFID) where alive in companywide facilities including PDA label Zebra-Wireless-Printers, in compliance with Confidential 21
• Wrote and executed UAT validation test scripts, documented test results in compliance with SOP.
• Review and evaluate validation assessments for application systems/projects.
• Drafted Standard Operating Procedures SOP and validation policies. Review/revise Validation Policy and SOP’s compliance as directed. Electronic Document Management System (EDMS).
• File validation documentation within following Quality Assurance Library guidelines in Global FDA/EMEA compliance.
• Customer Service Focused, System Audit/Quality/Regulated environment. Knowledgeable and understanding of IT concepts word processing as well as spreadsheet skills.
• Oversaw tasks and implemented the installation on configuring QTP webbase application testing using XML schema validation on QA compliance.
• Setup for validation protocols execution, schedule and update forecast in compliance with SOP. And design and Analysis of the requirements specs, assisted in implementation of PCA project.
• Defect reporting, follow up, update and incident closure and regular client interaction regarding the status of the project.

Confidential, Chicago

QA Tester Analyst

Responsibilities:

• Hands on Decommissioning plan.
• Responsible for SDLC software in writing test scripts on, .COM files, coding in Digital Command Language (DCL) C++ used DECForms and RDB on the VAX/OpenVMS platform.
• Conducted coding in .COM to assign, defined and purged/log files for automatic triggering of all job batches to update client transactions. Performed analysis of business requirement for accuracy, completeness, redundancy and testability.
• Defined testing scope, approach, risk and assumptions. Created and maintain testing project scheduled, revised were applicable, updating and executed UAT protocols of old and new test scripts of .COM files in a VAX/OpenVMS Dev-environment,
• Performed data impact analysis, queries back-end datasets, table using VSQL, utilized Lockbox services for data extraction and FTP for network file transfer and Business Management System (BMS) to extract .TXT from IBM, Xnet web-based application client into VAX.DAT files.
• Wrote and execute UAT validation test scripts and document test results, and identified and analyzed .LOG files for any deviations of .COM files are deployed into the production server environment.
• Submitted batch jobs to process the following: trading flow, pricing list, cashmove process, settlements, fees, rejects reports, pre-approved and post-approved banking transactions.
• Communicated with client’s inquiries, provided on-call support, and setup of DIS: Intranet mail services over Lotus Notes Domino for FIRECALLING CIT module to support group when system problems occurred.
• Scheduled weekly updates of project forecast report and communicated the status and metrics to project team management, senior leadership and project stockholders.

Confidential

Sr. Val/Lead SQA Analyst/Compliance

Responsibilities:

• Conducted validation reviews, revisions for testing for Confidential Sales force Marketing divisions, supporting their worldwide customers and reporting analysis activities, which were dependent upon several systems including: Via, Nucleus ePharma, focused on project deliverables such as regression resting, UAT testing, unit testing and integration testing.
• Gathered system requirements, analyzed the applicable specifications and provided (both front-end and backend). Developed test plan and test cases. Drafted Trace Matrix updates.
• Assumed leadership role in executing QA assessment test plan and strategized CRM, project Implementation Liaison between the (business users & sponsor).
• Participated in the technical review of projects deliverables including requirements specifications, functional designs, in cGxP 21 CFR Part 11, 210/211/810/820 compliance.
• Provided input/directions to the Quality Assurance efforts to project team, coordinated QA Validation resources and participated in the project team meetings.
• Collaborated with the stakeholders for project scope and product scope. Led testers team to gain understanding of the business processes and functional requirements, supported by the peripheral applications, mitigated software quality assurance methodology and achieved product scope objective.
• Developed test plan and test cases to execute (i.e) iCAS, CAPA, FileSurf, RAITS, ATLAS and Kintana in the XML files using web content generation on WebLogic, in WebTop applets eBrowser for R&D systems/eData and Disaster Recovery Plan processes.
• Wrote project summary, defect Reporting and recommendation action be taken if there any deviation encountered.
• Adherence to ensue cGxP; cGMP, cGCP, cGLP, IQ, OQ, PQ. UAT, compliance scorecards as well as ISOs Safety Performance Specs testing Methods are met.
• Assisted on setup and configured HP PDAs for Abbott field sales force, created charts presentations for eIND, eNDA, and eANDA, and eBLA presentations.
• Documentum (ECM) - COTS or Off-The-Shelf Documentum suite project. Drafted test plan for new customized modules, and upgraded/enhancements of test planning initiative. Documented test Staging and Production results in accordance with validation policy SOP standards and Quality Assurance Library guidelines for Documentum 4ix, 5ix+.
• FileSurf- Drafted implementation checklist for deliverables deployment into staging tests and rollout onto production.
• Siebel- Executed new Multi-Value Group (MVG) applet links and pick lists to meet business requirements and functioned in the role of Lead Support for validation efforts and deliverables. Validation plans, functional requirements specifications (FRS) and update protect Trace Matrix.
• Enterprise Integration Manager (EIM)-Executed bulk load flat files data EIM interface tables using SQL Loader and TOAD querying tool. Used SQL to analyze data verification on back-end tables followed by querying scenarios using test scripts and front-end GUI verification. QA record verification on Siebel XML schema. Setup and managed validation protocol testing environment CAPA- A CAPA enhancement project which I led initiative at ADD diagnostic division.
• Modified the EIM Table Mapping SQL loader CTL files and input Tables for populating data into the Siebel database. QA w/ HPQC-Test Director/QTP on web application and client server applications testing. Electronic Document Management System (cEDMS), and CRLN-Label-Tracking- CRLN-Label and Serialization/UDI Tracking, Bar-Code with 21 CFR part 201 compliance. iCAS CAPA calibration- Conducted major PDA (HP handheld) calibration for the professional sales force as well as for remote users. Participated in infrastructure setting up test lab, and production environments for archiving historical eDocumentations.