Matthew Fenning Email & Phone Number

North Port, Fl, Us

West Point, Pa

West Point, Pa

United States

Cranford, Nj

• Wrote and develop Archive Preparation Plans and Closure Reports for GMP record preservation• Wrote and developed validation test scripts for record archiving and ingestion into Records Management System• Using DROID application prepared and managed large data sets of files for arching preservation and created manifest document for metadata preservation

Trevose, Pa

• Work closely with the Harte Hanks project teams and its clients to accomplish a full client discovery and data / database solution review;• Document discovery and findings and work with the client, the project team and the development teams on next steps and creating accurate business and functional specifications in order to design a thorough technical requirements document;• Review current solution and advise on best-practice / optimized solutions to ensure that the client’s… Show more • Work closely with the Harte Hanks project teams and its clients to accomplish a full client discovery and data / database solution review;• Document discovery and findings and work with the client, the project team and the development teams on next steps and creating accurate business and functional specifications in order to design a thorough technical requirements document;• Review current solution and advise on best-practice / optimized solutions to ensure that the client’s business requirements are met;• Complete discovery and documentation in an agreed timeline in order to allow the internal and external teams to make the best decisions on current database solutions and next actions Show less

West Chester, Pa

•Act as Guide/Coach to system stakeholders through the J&J SDLC process, as per governing DePuy procedures;•Support the generation of a Compliance Plan (CP) & Compliance Report (CR);•Support the generation of applicable User Requirements; •Support the management of, and documentation resulting from an FMEA review of all requirements - this will assist in defining the scope of validation testing; including any SAP interfaces deemed within scope;•Support the generation and/or… Show more •Act as Guide/Coach to system stakeholders through the J&J SDLC process, as per governing DePuy procedures;•Support the generation of a Compliance Plan (CP) & Compliance Report (CR);•Support the generation of applicable User Requirements; •Support the management of, and documentation resulting from an FMEA review of all requirements - this will assist in defining the scope of validation testing; including any SAP interfaces deemed within scope;•Support the generation and/or updates of System Test Protocol and associated test scripts, in cooperation with IT Application and Business owners.•Support System Test Protocol review, and collation of all executed system test scripts;•Support the generation of a formal Requirements Traceability Matrix (RTM);•Support the generation and/or updates of User Acceptance Testing (UAT) Protocol and associated UAT test scripts, in conjunction with Business owners.•Support UAT Protocol review, and collation of all executed UAT test scripts;•Support the generation and/or update of Data Migration (DM) Qualification Protocol, inclusive of both phases;•Support Data Migration Qualification Protocol review, and collation of all executed DM Test Scripts for the DM Tool, and the actual Data Migrations;•Provide oversight for and review of all test defects, including documentation, analysis and reporting for the test activities above (IQ, System Test, UAT, DM Tools, DM.)•Support the generation, formatting, and/or updating of all required Work Instructions, in conjunction with IT Application and Business Owners. •Write and/or execute test scripts, as applicable. Show less

North Wales, Pa

Working closely with the business team and TrackWise Developers, responsible for designing TrackWise capable business processes that can be effectively implemented through development of reliable TrackWise applications. Extensive knowledge of TrackWise Version 7 and Version 8 Team Access and WebAdmin functions. Assisted in implementing enhancements to existing workflows and help design and implement new applications. Primary responsibility to ensure validation deliverables are created, approved… Show more Working closely with the business team and TrackWise Developers, responsible for designing TrackWise capable business processes that can be effectively implemented through development of reliable TrackWise applications. Extensive knowledge of TrackWise Version 7 and Version 8 Team Access and WebAdmin functions. Assisted in implementing enhancements to existing workflows and help design and implement new applications. Primary responsibility to ensure validation deliverables are created, approved by all required parties, and maintained to ensure the application’s continued validated state. Duties included integration and acceptance testing of new application projects along with regression testing of changes to existing applications. Other duties included: • Author and maintain validation documents for SDLC • Conduct user requirement gathering sessions and test script creation to comply with 21 CFR Part 11. • Assist in the development of training materials and user guide documents. • Language translations of both TrackWise system screens and training materials • Assist TrackWise report developers to build, review, test, and implement Crystal Reports • Automated requirements management and testing tools• Generate validation documentation deliverables to maintain project compliance. • Develop, coordinate, and implement plans to test business and functional processes during system development and quality assurance testing. • Maintain project based traceability matrices and master document lists. • Provide technical assistance and knowledge transfer for end user. • Consults and coordinates with the business to design and develop process improvement. Show less

Depuy Synthes

• Development of technical documents for validation of software applications• Development of OQ/PQ/URS/Test Scripts• Development and execution of validation script• Development of Traceability document

King Of Prussia, Pa

Manager, Quality and Compliance Practice - Software ImplementationTrackWise Decommissioning, Cubist Pharmaceuticals 03/12• Wrote and executed validation script for a TrackWise decommissioning project which consisted of closing out over 450 TrackWise records and shutting down all TrackWise Coordinator servicesTrackWise Training Manager, Maquet… Show more Manager, Quality and Compliance Practice - Software ImplementationTrackWise Decommissioning, Cubist Pharmaceuticals 03/12• Wrote and executed validation script for a TrackWise decommissioning project which consisted of closing out over 450 TrackWise records and shutting down all TrackWise Coordinator servicesTrackWise Training Manager, Maquet 03/12• Helped successfully resolve a development question for customer, Crystal Reports developmentQuality Assurance Validation, Sparta Systems Inc. 02/12• Assisted Sparta Systems Inc. with the validation and regression script development for TrackWise 8.4TrackWise Audit Manager Implementation, Perrigo Pharmaceuticals 01/12• Worked on the implementation of a new TrackWise Audit Manager deployment• Developed the Design Specification documents and performed other activities development activities while working closely with the Project ManagerValidation script development, J&J OCD 12/11• Developed multiple validation scripts for a TrackWise upgradeProject Manager/ Validation Lead, Shionogi Inc. 08/11-11/11• Managed the overall project and budget for TrackWise 8 implementation keeping all stake holders informed of all activities, this resulted in a high customer satisfaction• Led the validation activities for TrackWise workflow development and implementation Show less

Commenced and managed international team of 11 colleagues in support of software applications to reduce and/or combine 400+ applications over 76 global sites.• Successfully supervised helpdesk support transition of 2 globally deployed applications consisting of 25,000 users to offshore contractors within 4 months, 2 months ahead of schedule.• Managed Pfizer/Wyeth transition activities. Reduced overhead $250,000 through attrition and transfer of responsibilities.• Successfully… Show more Commenced and managed international team of 11 colleagues in support of software applications to reduce and/or combine 400+ applications over 76 global sites.• Successfully supervised helpdesk support transition of 2 globally deployed applications consisting of 25,000 users to offshore contractors within 4 months, 2 months ahead of schedule.• Managed Pfizer/Wyeth transition activities. Reduced overhead $250,000 through attrition and transfer of responsibilities.• Successfully supervised as the IT Manager for Sensitech’s ColdStream software upgrade implementation• Write and reviewed SOW for contractor procurement.• Supported on-site efforts in India and Ireland, traveling to locations. Show less

Supervised team of 4 colleagues including up to 15 contractors in continued deployment and support of global applications.• Performed project oversight for independent review and analysis for company wide IT systems integration project. Applied project management knowledge and expertise to gauge system performance using EVM principals and assess risk. Provided stakeholders with project status and outlook for success, and recommend project improvements• Manage software system development… Show more Supervised team of 4 colleagues including up to 15 contractors in continued deployment and support of global applications.• Performed project oversight for independent review and analysis for company wide IT systems integration project. Applied project management knowledge and expertise to gauge system performance using EVM principals and assess risk. Provided stakeholders with project status and outlook for success, and recommend project improvements• Manage software system development and integration projects using Microsoft Project through all phases of project life cycle - analysis, design, development, testing, implementation, and post-production support.• Supervised re-design and deployment of European Labeling Text and Artwork Repository (ELTAR) workflows in TrackWise application. This was accomplished through a highly collaborative effort with IT Professionals, Business and End User community.• Managed Manufacturing and Laboratory Investigation workflows in TrackWise which included LIR/MIR, Change Control and Action Request workflows along with Crystal Report development and deployment.• Team leader for QA testing. Developed testing plans and procedures for unit test, system test, and acceptance test.• Managed Master Validation Plan for TrackWise ensuring plan was appropriately followed. This included working on validation documents following GMP practices and holding milestone meetings with end users.• Managed highly successful periodic reviews, user recertification, and audit activities for validated systems.• Directed successful completion of multiple disaster recovery exercises.• Led and managed a highly successful database server migration, improving performance by approximately 60%. Show less

Collaborated with vendors, contractors and company teams to architect, design, and develop enterprise solutions involving ISOtrain and TrackWise computer systems.• Created and developed 400+ qualification and validation documents, protocols, SOP and Work Instructions following internal SOPs, policy and procedures in accordance with GMP and 21CFR Part 11 principals.• Acquired additional duties, leading a successful application decommissioning in a collaborative effort.• Wrote… Show more Collaborated with vendors, contractors and company teams to architect, design, and develop enterprise solutions involving ISOtrain and TrackWise computer systems.• Created and developed 400+ qualification and validation documents, protocols, SOP and Work Instructions following internal SOPs, policy and procedures in accordance with GMP and 21CFR Part 11 principals.• Acquired additional duties, leading a successful application decommissioning in a collaborative effort.• Wrote, reviewed and executed validation test scripts in support of global applications. Show less

Maintained large Access database for $20 million class action lawsuit. Designed and developed database applications and reports for law associates.• Performed statistical analysis work for affirmative action plans using Microsoft Excel. Also performed compensation analysis.

Insurance underwriting company, with approximately 15 employeesManaged daily operations and troubleshooting of Windows Server and maintenance of multiple client PCs and network printers. Developed software program in Visual Basic and Access keeping track of insurance claims, check and remittances for insurance products. Purchased all hardware/software inventories, with budget of approximately $30,000.• Upgraded network server with Microsoft Small Business Server• Designed custom… Show more Insurance underwriting company, with approximately 15 employeesManaged daily operations and troubleshooting of Windows Server and maintenance of multiple client PCs and network printers. Developed software program in Visual Basic and Access keeping track of insurance claims, check and remittances for insurance products. Purchased all hardware/software inventories, with budget of approximately $30,000.• Upgraded network server with Microsoft Small Business Server• Designed custom reports using Crystal Report Show less

Supplier of custom software solutions for military and business applications, with 30 employeesDeveloped insurance underwriting program featuring complete functionality for premium finance, claims and check tracking along with report design using Visual Basic and Crystal Reports. Wrote IEEE standard software documentation required for all the software applications developed.

Responsible for the processing of genomic information used for the construction of genetic maps of the human chromosome. Wrote program code in Perl to format and extract genetic data for processing using SQL to query a Sybase database to retrieve genomic data.

Responsible for the maintenance and operation of the facilities 20-watt argon and 5-watt DYE lasersDeveloped computer code for light track analysis and two-dimensional photodosimetryPerformed verification measurements of light intensity in solid tumors. Assisted with both in vitro and in vivo studies to characterize novel photosensitizing drugs and tumor mechanismsAssisted in the pharmacokinetics of novel photosensitizing drugs and hypoxic marker drugs.Consultant… Show more Responsible for the maintenance and operation of the facilities 20-watt argon and 5-watt DYE lasersDeveloped computer code for light track analysis and two-dimensional photodosimetryPerformed verification measurements of light intensity in solid tumors. Assisted with both in vitro and in vivo studies to characterize novel photosensitizing drugs and tumor mechanismsAssisted in the pharmacokinetics of novel photosensitizing drugs and hypoxic marker drugs.Consultant WorkCrystal Reports Report writing, extracting data from Centura SQLBase databaseMaintained and developed Visual Basic and Access applications for; Developed Visual Basic and Access application used to track service and referral data for a social services company. Show less

Masters, Computer Information Science

Bachelor Of Science (Bs), Physics

Certificate, Oracle Accelerated Curriculum

Academic