Career Overview

• Experience obtained in areas of Engineering, Manufacturing, Quality/Regulatory and IS Security working as a Business IT professional for over 30 years. Experience includes requirement gathering, technical writing, testing, project management, training and support. Project experience includes budget, resource, vendor, quality and time management. Additional opportunities embraced include compliance, process improvement, gap and process flow analysis, software remediation, document control and release management.
• I pride myself on quality work, excellent technical writing and communication skills, attention to detail and my ability to embrace varied cultures and individuals. My ability to quickly assess any situation such as user requirements, gaps in processes and testing needs is a strong point of what I have to offer.

Qualifications/Skills

Work Experience

Confidential

Title: Project Planning Specialist

• Performed multiple, simultaneous project functions for IS and Engineering projects including: Two Factor authentication, global desktop upgrade and migration to eWorkplace environment, firewall upgrades, facility network infrastructure upgrades, SPLUNK security module installation and use, Live On-demand video streaming, purchase and roll out of >500 traveler laptops for sales and executives and inventory available laptops SCCM upgrade.
• Created, developed and maintained sixteen project plans and Work Breakdown Structures, using MSProject, for Capital and non-Capital projects ranging from 17,000 - 12,000,000.
• Created and maintained resource planning and timesheet system EPK for >200 resources.
• Created, developed and maintained project intra-company website using SharePoint software.
• Maintained project request, approval and financials using ProSight.
• Monitored and presented financial reports to project manager for > 1 million project.
• Generated SOX, status and labor reports for project managers using MSExcel, Cognos and other applications.
• Responsible for obtaining, generating and archiving project related documents including: process flows, requirement documents, training plans, communication plans, spreadsheets, etc.
• Requested creation and closure of company purchase orders for hardware/software/labor internal and contractor.
• Utilized SAP company order, purchasing, receiving and reporting interfaces.
• Coordinated and ran project team meetings.
• Participated in Project Office department activities meetings, presentations and workshops .
• Coordinated with Capital Admin, Purchasing, Training, QC, Engineering and IS Security depts.
• Developed test scripts.
• Coordinated and assisted with testing activities within HP Quality Center Software.

Confidential

Title: IS Business Analyst

• Performed multiple, simultaneous team functions for IS Security projects, including: FCC Narrowband Compliance Security Log Management Encrypted Storage Devices Intrusion Detection Device, Virus Protection and Firewall Installations.
• Gathered/documented business/functional requirements.
• Developed test scripts.
• Developed and published Deployment, Communication, Training and Testing plans.
• Performed and documented equipment inventory and license lists.
• Generated Statement of Work documents for submission to vendors.
• Coordinated and assisted with testing activities within HP Quality Center Software.
• Queried information from within the national FCC License database.
• Developed document templates Requirement, Validation Plan, Installation Qualification and Project Phase Checklists for the Global Project Office team.

Confidential

Title: IT Business Analyst

• Performed project management duties including creation of project plans and Work Breakdown Structures, managed resources and monitored timelines.
• Managed and performed software release functions confirming completion of documentation, validation accuracy, meeting of established requirements and appropriate signatures.
• Gathered user/functional requirements for in-house and COTS software.
• Developed design specifications for software applications, infrastructure and reports. Executed validation plans and test scripts including Installation Qualifications IQ , Operational Qualifications OQ , Performance Qualifications PQ and User Acceptance Tests UAT .
• Wrote and published all documents required during the SDLC process including: Project Proposals, User/Functional Requirements, Design Specifications, Validation Plans, Test Scripts, SLAs, Decommission Plans, Project Plans.
• Performed as resource for CAPA investigations and resolutions related to product quality and software requirements.
• Provided application and business process support for over 500 users in 3 quality applications Pilgrim's Q MIS 2 installations and Infinity's Proficient SPC .
• Supported Quality, Engineering, Purchasing and Manufacturing departments in software implementation, process improvement and data management.
• Supported the following business processes: product inspection, nonconformance, equipment maintenance, gauge calibration, SPC.
• Managed account creation/deactivation for multiple applications.
• Adhered to 21 CFR Part 11 requirements related to document and data storage, electronic signatures and audit trails.
• Helped design and implement IT Change Control process.
• Compared software packages and vendor proposals for implementation of new solutions.
• Participated, as a primary resource, in infrastructure project to implement virtual servers in a Citrix environment for supported applications.

Confidential

Titles: Business Analyst, Project Leader, Project Facilitator, Database Administrator,

Sr. Documentation Coordinator, Engineering Drafting and Documentation Specialist

• Managed 6 high profile projects from start to finish. Responsibilities included all aspects of project management: cost estimation, resource identification and management, ROI definition, risk management and hosting team meetings while keeping all projects within the defined timeline and budget.
• Managed and performed software release functions confirming completion of documentation, validation accuracy, meeting of established requirements and appropriate signatures.
• Gathered user/functional requirements for in-house and COTS software.
• Developed design specifications for software applications, infrastructure and reports.
• Executed projects for infrastructure efforts such as Citrix, Unix servers, disaster recovery and Windows.
• Managed team of programmers/developers
• Implemented first and second applications in company to utilize electronic signatures.
• Executed validation plans and test scripts including Installation Qualifications IQ , Operational Qualifications OQ , Performance Qualifications PQ and User Acceptance Tests UAT .
• Provided application and business process support for over 500 users.
• Supported the following business processes: product inspection, nonconformance, CAPA, equipment maintenance, gauge calibration, engineering and manufacturing data sharing, engineering product management.
• Wrote and published documents required during the SDLC process including: User/Functional Requirements, Design Specifications, Test Scripts and Project Plans.
• Implemented Q MIS interface in two languages: Spanish and Czech.
• Implemented and designed data transfers to Q MIS from ERP and engineering databases.
• Executed scanning project with OCR for Regulatory Affairs documents.
• Wrote code, designed database table structure using Informix SQL and Informix 4gl and supported an extensive, in-house developed engineering product management application. Program had over 300 users and was deployed domestically and internationally.
• Supported document control application Documentum 200 users for Quality System documents, Regulatory Affairs and MSDS documents.
• Played primary role in implementation of ISO/FDA compliance programs for Engr., QC and RA.
• Managed account creation/deactivation for multiple applications.
• Compared software packages and vendor proposals for purchase of new solutions.

Major Accomplishments

• Performed a major role in an Operational Excellence program to improve non-conformance and CAPA processes including metric gathering, documentation, root cause identification and investigation processes, resulting in a favorable FDA audit.
• Executed training for nonconformance and CAPA processes.
• Managed and provided the technical lead for 6 simultaneous, successful and within budget quality software projects deployed in 7 world-wide facilities ultimately providing common data and processes across multi-cultural and physically diverse environments.
• Simultaneously supported 3 quality software applications for 7 facilities in 3 countries allowing product releases to occur as expected and on-time for downstream manufacturing.
• Reviewed and remediated previously executed test scripts for multiple applications assuring documentation compliance and proper discrepancy handling, resulting in a favorable FDA audit.
• Designed and executed multiple data migration efforts allowing for system integrations and process automations ultimately improving the manufacturing and quality initiatives.
• Held multiple positions in software vendors' user councils resulting in improvement of usability and functionality of COTS software.
• Delivered multiple presentations at software user conferences which allowed for sharing information with peers and ultimately enhancing the user/vendor relationship.
• Created 400 page comprehensive training manual for quality software application which resulted in improved training methodology and higher degree of user understanding.
• Taught over 100 application and business process training classes resulting in a sophisticated and knowledgeable user base.