SUMMARY:

• To pursue new opportunities related to my experience and knowledge related to Computer Systems Validation, Business Analysis, and Quality Assurance endeavors
• Including management and execution of testing techniques both manual and automated utilizing tools such as HP Quality Center, HP - ALM, Agile Rally and JIRA/JAMA.

PROFESSIONAL EXPERIENCE:

Confidential, Bellerica, MA

Business Analyst

Responsibilities:

• Developed the high-level User Requirements for the upgrade to Oracle Argus 8.0 from Argus 7.0.
• Developed the Business Requirements (BRD) needed to acquire the necessary funding for the project.
• As Paraxel does perform the actual input as well as reporting functions based upon FDA compliance for a great number of external clients, investigations were underway as to the best methodology to be used for the multi-tenant capabilities within the Argus 8.0 application.
• Based upon those results, a single database capable of maintaining multiple enterprises and hosted internally was determined to be the most efficient.
• Had to give notice due to family medical crisis.

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:
• UAT and Functional test script creation
• IQ Scripts - (Pre-prod and Prod environments)
• IQ Scripts - post-execution
• 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)
• 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.

Confidential, Marlborough, Ma

Consultant/Computer Systems Validation Engineer/Quality Engineer

Responsibilities:

• Provided support on the validation of one major applications: The rfXcel Product Serialization rTS system. The Drug Quality and Security Act (DQSA) of November 2013 which passed as law on January 1, 2015 requires Pharmaceutical manufacturers, distributors, and dispensers to:
• Pass lot level transaction (DSCSA) 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
• 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.
• All of the aforementioned activities were tested with the creation of test scripts for IQ, OQ, PQ, UAT, and Functional specifications.
• EPCIS Repository where serial numbers can be viewed, managed, and tracked. The major emphasis was placed on the serialization of all products manufactured, distributed, and warehoused by suppliers or wholesalers. (CMO, CPO).
• Validated a LIMS system from LabVantage, Inc.
• 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 CFR21 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.
• Empower2Software, a,chromatography datasoftware(CDS), was also reviewed regarding compliance along with the addition of newsoftwareto support instruments or advanced chromatographic techniques.

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 SCADA (supervisory control and data acquisition system) used within various departments (i.e. granulation, compounding) in the manufacture of drug products.

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 CFR21 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 using Agile Rally
• Coordination of testing execution (Personnel and scheduling)
• 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.
• HP Quality Center ALM was the tool used for actual testing of all requirements.
• Creation of Requirements, Test Plan creation of folders for test subjects in the test plan tree, and creation of test sets within Test Lab for the execution of the test instances.
• Defects were both tracked and resolved prior to the release into production
• Analysis and Dashboard Views utilized periodically.

Confidential, Hartford, CT

Consultant/Lead Test Manager

Responsibilities:

• 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 ALM with 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 test 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, Cambridge, MA

Consultant/Lead CSV Validation Engineer

Responsibilities:

• 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, Stamford, CT

Consultant/Lead CSV Validation Engineer/QA Tester

Responsibilities:

• 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.