SUMMARY:

To pursue new opportunities related to my experience and knowledge related to Computer Systems Validation, Business Analysis, and Quality Assurance endeavors.

PROFESSIONAL EXPERIENCE:

Confidential, Glastonbury, Ct

Consultant/Computer Systems Validation Engineer/Senior QA Engineer

Responsibilities:

• Developed a complete SDLC process for the validation of the iEmvision Platform which incorporates 4 major applications that utilizes medical information for the pharmaceutical industry. The platform supports the development of high - quality, scientifically accurate publications that inform appropriate target audiences about clinical and nonclinical developments within the healthcare environment.
• The SDLC process incorporates a complete set of validation documents that are FDA 21CFRPart11 compliant using GAMP5 latest guidelines.
• The initial application, Medical Information Version 1.0, was completely validated and the lessons learned from this validation will provide the ability for the company being able to continue with the remaining validation of their remaining applications. The following documentation was created:
• Validation Project Plan
• Risk Assessment
• User Requirements-Worked as a BA in elicitaiton of requirements
• Functional Specifications-Worked as a BA in elicitaiton of requirements
• Configuration Specification
• Installation Qualification Protocol
• IQ Scripts - (Pre-prod and Prod environments)
• IQ Scripts - post-execution
• (Pre-prod and Prod environments)
• Installation Qualification Report
• Operational and Performance Qualification Protocol
• OQ/PQ Scripts-worked with QA in producing these scripts based upon requirements
• OQ/PQ Scripts - post-execution
• Operational and Performance Qualification Report
• Data Migration and Cutover Plan (including system decommissioning)
• System Release Memorandum
• Traceability Matrix
• Validation Summary Report
• Training Materials and/or plan
• Procedural Documents- (SOP’s related to CAPA, Change Control and Validation Policy)
• Suggested CAPA software for the investigation, root cause analysis, planning, monitoring and reporting of deficiencies.
• During the validation process performed many BA functions (i.e. requirements gathering, liaison with business and IT colleagues)

Confidential, Marlborough, Ma

Consultant/Computer Systems Validation Engineer/Quality Engineer

Responsibilities:

• Pass lot level transaction ( Confidential ) reports to downstream supply chain partners (customers).
• Provide a mechanism to verify products legitimacy.
• Handle suspect product investigation.
• Respond to requests for information by reviewing lot level transaction reports.
• Serial Number Creation, Allocation and Management
• EPCIS Repository where serial numbers can be viewed, managed, and tracked.
• The LIMS is a configured laboratory information database which includes the functionality to: enter and store drug product test data, create stability studies, and generate validated reports. LIMS is utilized by contract laboratory sites to support development and commercial product release and stability.
• The documentation prepared for these systems followed the Software Development Life Cycle (SDLC) process that was instituted by Confidential, Inc. In conjunction with Sunovion’s internal IT-Validation Department and chosen vendors, all documentation was prepared and did adhere to the FDA Code of Federal regulations, EMEA guidelines, and GAMP5.

Confidential, Melville, NY

Consultant/Computer Systems Validation Engineer

Responsibilities:

• A total of 17 Periodic Reviews as well as Risk Assessments were prepared for laboratory equipment to determine their compliance with Confidential Part 11 and other regulatory requirements. Based upon the findings, a great number of the instrumentation assessed was deemed to be deficient in their compliance along with a lack of documentation to support a System Development Lifecycle (SDLC) Validation process and that remedial action was suggested to the client.
• Proposals are being created for the remediation of these legacy systems.
• Empower2 network connectivity
• Ion Mobility Spectrometer (IMS)
• Sievers 900 Series TOC Analyzer
• Celsis Advance Luminometer
• UV - Spectrophotometer
• FT-IR Spectrophotometer
• Raman IR
• Near IR
• Omnicon Zone Reader
• Balance(s)
• Polarimeter
• KF Titrator
• Viscometers
• Fedegari Autoclaves
• GC’s (Perkin Elmer & Agilent)
• HPLC’s - (Utilizing Empower2) uPLC’s - (Utilizing Empower2)
• Perkin Elmer TotalChrom

Confidential, Suffern, NY

Consultant/Quality Systems Decommissioning Engineer

Responsibilities:

• Assessment of the current SAP Quality Management (QM) module which is an integral part of the logistics function and within the SAP system it is fully integrated with complementary components including Materials Management (MM), Plant Maintenance (PM), and Production Planning (PP).
• Assessment of the Confidential (supervisory control and data acquisition system) used within various departments (i.e. granulation, compounding) in the manufacture of drug products.
• Preparation of the Decommissioning Project Plan
• Review of the existing Periodic Review and creation of a revised Periodic Review noting changes that had occurred.
• Use of IT Change Management Procedures
• Identifying all hardware components
• Identifying all software components (Oracle databases)
• Identifying latest version of the operating systems
• Termination of SLA's and software maintenance agreements
• Locations involved with the decommissioning
• Personnel/User notification of system decommissioning
• Testing of data from production environment migrated to storage repository
• Overall impact on other interfaces
• Final Summary Reports

Confidential, Cheshire, CT

Consultant/Quality Systems Validation Engineer/Testing

Responsibilities:

• Liaison with business stakeholders, IT technical staff, outsourced vendors
• Creation and review of IQ, OQ, and PQ test scripts within three environments (Test, Val, and Prod)
• Defect identification, tracking, and reporting during testing using Track Wise.
• Applicable change control processes that were utilized.
• Followed Confidential Part 11 for eSig and electronic records.
• Project management scheduling and resource allocation
• Creation of SDLC documentation (Entire lifecycle)

Confidential, Andover, MA

Consultant/Quality Systems Validation Engineer/Testing

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, and Scripts
• Coordination of testing execution (Personnel and scheduling)
• Understanding of Active Directory was used as a log in procedure with Windows OS
• Defect identification, tracking, and reporting
• Applicable change control processes to be implemented
• Creation of SDLC documentation using the Agile Document Management System.

Confidential, North Kingston, RI

Consultant/Quality Systems Validation Engineer/Test Manager

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, Hartford, CT

Consultant/Lead Test Manager

Responsibilities:

• System Integration (SIT)
• Performance/Stress Testing
• Federal Data Services Hub Transmissions
• User Acceptance (UAT)
• Regression Testing
• Blueprint Scenarios/CMS
• End-to-End Testing/CMS

Confidential, Marlboro, MA

Consultant/Lead CSV Validation Engineer

Responsibilities:

• 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 Confidential 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.

Confidential, Summit, NJ

Consultant/Database Programmer

Responsibilities:

• 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, Hartford, CT

Consultant/ Business Analyst

Responsibilities:

• Developed metric information associated with the Consumer Experience Initiative developed by Confidential . 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, East Hanover, NJ

Consultant/Validation Engineer

Responsibilities:

• Worked in a consulting position as a Validation Engineer in producing all relevant documentation for the Confidential 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 Confidential Compliance standards.
• In conjunction with this validation process, all necessary SOP’s, WIP’s etc. is being revised to in corporate 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

Responsibilities:

• 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 Confidential ’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, Groton, CT

Business Analyst Consultant

Responsibilities:

• 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.Ensured that applications were configured with Citrix server so that when accessing a dashboard you could invoke applications.
• 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.