EXPERIENCE:

Confidential

Consultant/Quality Systems Validation Engineer/Testing

Due to a major effort to standardize global applications, a key element within this transitional period was the testing of existing applications within new IT environments. To accomplish this objective, integration teams were responsible for creating and maintaining test plans. The Agile methodology was used in the creation of User Stories and Test cases that led to the eventual creation of both User requirements and Functional requirements documentation. Sprints were run at periodic time intervals with all defects being captured, tracked, and resolved. These scripts were created and executed primarily in manual modes and many were outsourced to vendors.

Key responsibilities:

• Creation of Test Plans, User requirements, Functional requirements, Test Summary
• Liaison with business stakeholders, IT technical staff, outsourced vendors
• Creation of User stores, Test cases, Scripts
• Coordination of testing execution Personnel and scheduling
• Defect identification, tracking, and reporting
• Applicable change control processes to be implemented
• Creation of SDLC documentation

Confidential

Consultant/Quality Systems Validation Engineer/Test Manager

A major upgrade to the company's Laboratory Instrumentation Management System LIMS was in the process of being both validated and tested. Due to regulatory requirements a complete validation of the system had to be performed. This was an initial validation of the LIMS system and a complete SDLC process had to be created and implemented. The following responsibilities were required and executed.

Key Responsibilities:

• Initial creation of a SDLC process involving the preparation of eight templates.
• The SDLC would use a GAMP5 risk based approach.
• HPQC would be the tool used for actual testing of both UAT and Functional testing
• Creation of Use Cases and scripts were created and executed
• Deviations/Variances were both tracked and resolved prior to the release into production

Confidential

Consultant/Lead Test Manager

• In conjunction with First Data Corporation, hired as a lead test manager to verify and validate all aspects of testing for the Access Health Marketing Exchange Application for the state of Connecticut as part of the newly formulated Patient Protection and Affordable Care Act commencing on October 1, 2013.
• The elements of testing include:
• System Integration SIT
• Performance/Stress Testing
• Federal Data Services Hub Transmissions
• User Acceptance UAT
• Regression Testing
• Blueprint Scenarios/CMS
• End-to-End Testing/CMS
• In each case, actual scenarios or test cases were written, verified, and executed. Cases were deployed from JIRA and all defects with resolutions were tracked in JAMA. However, UAT testing was performed using Quality Center with manual test scripts being prepared and all variances defects tracked and resolved. Upon successful completion of all tests, letters of attestation were written and submitted to the federal Centers for Medicare Medicaid located in Bethesda, Maryland. CMS .
• All testing results were published in a monthly status report and submitted to Access Health Management, State of Connecticut, and the federal Centers for Medicare Medicaid Services CMS .

Confidential

Consultant/Lead CSV Validation Engineer

Worked within the Millennium Informatics Strategy Organization on the validation of the Pharmacovigilance Safety System- Oracle Argus. As the lead CSV validation engineer, all documentation for the system was created that followed Millennium's internal SDLC process, as well as the preparation and execution of test scripts for configurable reports requested by the business stakeholders. All necessary SOP's, change control requests, and protocols were also prepared. These reports were created in Cognos and Insight for Argus. Additionally, SOP's, protocols, and change controls were also created and/or revised to adhere to the project schedule. Since this system was also of a global nature, E2B transmissions were conducted and tested utilizing Synchrony Cyclone for receipt by the FDA and EMEA and other internal partners. Also, the use of BI technologies Crystal Reports, SQL Queries, and TOAD along with applications to analyze internal structured data were used as part of the overall validation effort.

Confidential

Consultant/Lead CSV Validation Engineer/QA Tester

• Worked as an independent CSV consultant developing User Requirements, Functional Requirements, and User Acceptance Testing Requirements for the release of 3 three newly developed Nucleic Acid Tests NATs software applications. Test cases and scripts were developed in two phases. The first phase was tested in Agile's RALLY testing software with the development of User Stories and test scripts and the second phase is currently being tested in HP's Quality Center 10.2. The Agile methodology was being used in the testing phases for each of the projects. Results were finalized and a Final Test Summary Report was created and approved as part of the validation process for the applications.
• Along with the testing of the applications, a complete SDLC process was also being used to conform to FDA regulations and guidelines. This process involved the creation of the following documentation: Validation Project Plan, User Requirements Specification, Design Specification, Functional Specification, Traceability Matrix, IQ, OP, PQ Testing, Test Summary Reports and a Validation Summary Report. New policies and associated SOP's were also being created as the SDLC for Computer System Validation will be using Microsoft Team Foundation Server processes along with Microsoft Visual Studio Test Manager in the future.

Confidential

Consultant/Lead Validation and Documentation Specialist/IT Operations

• Performed computer system validation in its entirety on three Commercial- off- the- shelf products by Liquent, Inc.for submissions to the FDA and they were:
• Insight Publisher- InSight Publisher Version 3.6.2.1 provides the ability to create submissions in compliance with the Electronic Common Technical Document eCTD , eHybrid/ NeeS and paper documentation standards.
• eCTD Reviewer Version 1.2.2- provides additional publishing functionality to verify the submissions content and integrity of the eCTD submission.
• Insight Viewer- Insight Viewer Version 2.0 provides viewing and reviewing capabilities for in-process submissions.
• Each system followed SDLC and GAMP5 risk based guidelines and procedures established by Schering-Plough in conjunction with compliance to all FDA regulations.
• Performed both Functional Verification FV testing and User Acceptance Testing UAT using HP Quality Center v9.0 software. Performance testing was executed using WinRunner.
• Documentation that had been authored included a Development Testing Plan, FV scripts, execution of scripts, Development Summary Report, Traceability Matrix, UAT scripts, leading to the Validation Summary Report.

Confidential

Consultant/Lead CSV Validation Engineer

• Performed computer system validation and compliance on four 4 major pharmaceutical systems
• Oracle- Adverse Events Reporting System AERS Version 4.6.1 . The system addressed both Safety related and Adverse Reporting issues related to Pharmacovigilance- the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. The process does follow SDLC methodology in keeping with 21CFR Part 11 requirements and related GCP Compliance standards.
• Octagon's ViewPoint version 3.10.2. An Electronic Drug Submissions interface utilizing eCTD templates. The use of ISI Toolbox was also part of the validation.
• Stay in Front CRM 11 software. Sales Territory Analysis and Reporting System. Used by marketing and sales force personnel in the electronic placement of orders with the ability of determining projected trends
• Trackwise- A Quality Management Software Application that was used for both complaint handling and nonconformance tracking. The main emphasis was the creation and validation of 7 newly created reports as well as the modification of 4 existing reports. Through the use of query, the reports provided the user community with instant retrieval of selected criteria to identify potential problem related areas as well as tracking of all CAPA incidents and resolutions.
• Each followed SDLC and GAMP 5 risk based guidelines along with compliance to FDA regulations. Since two of the systems are global, both EU and Japanese guidelines will also be part of their validation process. All documentation was prepared for the overall process which included complete IQ, OQ, PQ, and UAT scripts for testing. The AERS upgrade was performed within three distinct environments Development, Test, and Production . Other documentation included Validation Project Plan, User Requirements, Functionality Specifications, Traceability Matrix and Validation Summary Report. Project Management capabilities for scheduling, resource allocations, and budgetary alignments were also prepared for coordination with IT, Business Sponsors, and application vendors.
• Internal SOP's were developed and an automated Database Change Management System was developed for the control of all ongoing activities once the systems were validated. The system initiates, routes the changes for necessary departmental inputs, and eventually to management for approval. The system will also track and trend occurrences using query techniques.
• Worked with and configured EMC Documentum eRoom which optimized collaborative business processes.
• Performed other business analyst's functions i.e. business process flows, preparation of technical documentation, User Manuals, along with the use of BI technologies for report generation...
• Utilized Telelogic System Architect for Enterprise Architecture and Business Process Analysis.
• Utilized SQL Query and TOAD for data analysis.

Confidential

Consultant/Database Programmer/Visual FoxPro 9.0

• Designed and programmed a Visual FoxPro v 9.0 database for the tracking and reporting of stability samples within eighteen 18 stability chambers.
• With the use of SQL Query and FoxPro reporting, management had the ability to determine the exact status of samples and the anticipated pull dates needed for each.

Confidential

Consultant/ Business Analyst

• Developed metric information associated with the Consumer Experience Initiative developed by United Health Group. The various analyses involved the interaction with eight independent business segments in acquiring both statistical information and access to various IT platforms for the creation of SQL queries to develop the needed results.
• Information gathered would depict defect parameters within certain data elements so that pilot projects and assessments could be conducted to determine the feasibility of implementing different and improved methodologies within the business processes.
• During this process, the use of Project Portfolio Management PPM software was used to describe methods for analyzing and collectively managing a group of current or proposed projects based on numerous key characteristics. The software used was TeamWorks PPM.

Confidential

Consultant/Validation Engineer

• Worked in a consulting position as a Validation Engineer in producing all relevant documentation for the Migration of the Clinical Trial application package PhOSCo ver.1.5.0 to ver. 1.5.1. The process does follow SDLC methodology in keeping with 21CFR Part 11 requirements and related GCP Compliance standards.
• In conjunction with this validation process, all necessary SOP's, WIP's etc. is being revised to incorporate any additional changes as deemed necessary.
• This validation process involved the development of flow diagrams, use of UML 2.0 modeling, protocol development, business requirements, functional, design, and technical specifications, SOP's, IQ/OQ/PQ documentation along with the creation of test scripts.
• Many of the documentation formats or templates used in this overall process incorporated the Crystal Methodology.

Confidential

Independent Consultant/ FoxPro Programming

• Worked as a consultant developing various Visual FoxPro applications written in Visual FoxPro 9.0 using query along with the use of Seagate Crystal Reports as an additional means of report creation.
• The applications were being developed for the Newington Elementary Children's Center, Inc. NECCI located in Newington, Ct.
• These applications involved a number of billing, scheduling, and tracking of pertinent information i.e. EEO data, medical data, etc. associated with the center's requirements for internal control and that dictated by the State of Connecticut. Data from their accounting system is also uploaded into various tables within the applications to further enhance their ability to produce comparative analysis for trending and budgetary forecasting.

Confidential

Business Analyst Consultant

• Created documentation related to the validation of a Global Learning Management System LMS . The application/vendor chosen was SumTotal Enterprise Suite Version 7. Power to Learn .
• Responsibilities included the development of a project plan, business requirements through information gathering with business owners, design specification, test plan, test scripts for UAT, traceability matrix, and a validation summary report. The process followed SDLC practices, use of UML modeling, compliance with GMP requirements and 21CFR Part11. This project also involved the migration of all data from an earlier version of ASPEN software which went through a formal retirement The system will eventually be rolled-out to other Pfizer divisions within the US, England, Canada, and Japan.
• Involved with the installation, qualification and validation of Perkin Elmer TotalChrom 6.3.0 within the BioPharma laboratory located in St. Louis, Mo. This validation process involved the development of flow diagrams, all protocols, SOP's, IQ/OQ/PQ documentation and UAT scripts associated with terminal servers, MCI's, interfaces and instrument configuration. The validation effort was governed by GLP procedures and practices which were strictly enforced. Windows Server 2003 was the OS for servers and Windows XP was installed for the clients Both small and full clients . Citrix server was used for publishing the application to the client and migration of previous statistical data was also accomplished. The use of Mercury WinRunner was used during the various testing phases.
• Responsible for the migration of the Phase-Forward Clintrial application. The application was comprised of both Electronic Data Capture EDC with the use of InForm and clinical data management CDM . Once again this validation process involved the development of flow diagrams, protocols, development of business requirements, functional and technical specifications, SOP's, IQ/OQ/PQ documentation and UAT scripts.
• Scheduled and implemented the development of the eArchive initiative at Pfizer and in particular the creation of policy and procedures for Metadata, Change Control, Ingestion portal , Accountability Audit trails , Training, and Data Retention Schedules. Along with policy creation, discussions took place with Content Management Vendors namely EMC Documentum and Open Text LiveLinkECM, along with business owners and sponsors to develop the business requirements needed to accomplish this initiative.
• Having both technical and administrative knowledge of both Documentum and LiveLink, certain LivelinkECM modules were tested to determine their overall capabilities. These modules were Document Management, Records Management, Content Archiving, and Content Lifecycle Management. The criteria for the project involved the ability to associate metadata and attributes with documents, index this metadata for rapid retrieval, and generate reports or queries on documents based on custom criteria. There was also the need to schedule items for archival and destruction based upon certain rules, link business objects to unstructured content, retain detailed audit trails, the use of permissions, and reduce storage space considerations.

Confidential

Consultant/Validation Engineer-Remediation Project

• Worked as an independent consultant for Schering-Plough Pharmaceuticals, Inc. on the major task of remediation of Legacy Computer Systems. This involved both computer validation techniques and remediation efforts in order to bring these systems into compliance with both 21CFR Part 11 regulations and GMP standards.
• The process involved investigative liaison efforts with both internal and external clients to determine requirements which led to the creation of relevant documentation. GAP Analyses and Feasibility Reports were written to illustrate the current As-Is configuration of an application versus the feasibility of proposed remediation efforts which could include modifications to existing systems or the replacement to newer technologies. These efforts would include both business strategies and IT technologies that would be needed along with proposed costs and associated resource allocations. Retirement of current systems was also a consideration.
• Based upon management's approval, Remediation or Project Plans would then be created followed by the development of both technical and functional specifications. Schedules for both Functionality and User Acceptance Testing would be determined and the necessary test scripts would be written. Once tested and the IQ, OQ, PQ requirements met, a final summary report would be created and approved. Necessary SOP's etc. would than be established and the entire process did follow the SDLC process.

Confidential

Manager-IT Systems/Applications

• Planned, developed, tested and documented computer programs applying knowledge of database programming techniques and computer systems.
• Applied knowledge of Microsoft Access, Visual Basic and Visual FoxPro 3.0 and 5.0, in conjunction with Seagate's Crystal Reports and R R Report Writer for data management applications Report writing and query language techniques were implemented within the applications.
• Developed an automated tracking and trending system for analysis of statistical information within Quality Assurance, manufacturing, laboratories, and administrative departments.
• The LIMS system gathered statistical data by both manual and electronic inputs i.e. HPLC's, and compared those results against known specifications. Limits were determined and were continually reviewed and updated to refine laboratory specifications. These databases were used as a front end for SQL databases.
• Developed an automated SOP system whereby nearly 1400 SOP's were created, modified, tracked, and implemented within all operational and administrative departments.
• Applications were run in a Windows NT environment utilizing over 40 servers for a population of 400 employees.
• Prepared flowcharts and flow diagrams to illustrate sequence of steps that a program must follow and to describe logical operations involved. This also involved formal IQ, OQ, and PQ testing along with UAT protocols and test scripts.
• Was instrumental in the validation of computer systems for FDA cGXP requirements based upon Federal Regulation 21CFR Part 11.
• Trained in NT administration, SQL server administration, and Novell 5.
• As a Project Manager, coordinated efforts with subordinates and management in identifying and resolving problem areas.
• Taught staff and key employee's computer software and basic techniques.

Confidential

Independent Consultant

• Worked at various companies developing software applications, teaching of personnel, and installation of networks.
• Companies included The Torrington Company, United Technologies, Inc. and Goodwill Industries.
• Wrote accounting and inventory applications for numerous small businesses.