SUMMARY:

Over 24 years of experience in software development lifecycle (SDLC) supporting IT projects in product selection, process creation,, review process, development and quality assurance. Strong contributions to corporate goals through leadership; improvements in operations, processes, and workflows; communications; and facilitation of team development and individual mentoring.

SKILL:

Executed: Various Organizational Software Development Life Cycle (SDLC) Models (Waterfall, V Model, Iterative, and Spiral), Information System Project Delivery Methodology (ISPDM), Various ISO Standards (900X, 13485, 14971, 14969), Application Lifecycle Management (ALM), Agile Methods, FDA (CFR 21 part 11, 210, 211 & 820), Annex 11, GAMP 4 & 5, GxP (GDP, GLP, GMP), Corrective Action/ Preventive Action (CAPA) Remediation, DEA/FDA guidelines dealing with Form 05 and 1311), European ENs, International Association of Privacy Professionals (IAPP), CISPR, QS9000 (automotive), IEC 61000, EMC, CE Mark, Six Sigma Production & Process, UL Standards, ARI Standards and various organizations’ SOPs/WIs. Software Tools Utilized MS (Word, Excel, Power Point, Project, Visio, SharePoint, OneNote, Outlook), Jira, Confluence, SpriraTeam.

Systems Validated: Document Management Systems (DMS), Custom Developed Applications, Commercial Off the Shelf (COTS) or Out of the Box (OOTB) Applications, Quality Management Systems (QMS), Change Management (CM)/Change Control Systems, Web Based Internal/External Hosted Systems, SAP Systems, SaaS Systems, Financial/D Confidential Management, Enterprise Resource Planning (ERP), Customer Relationship Management (CRM), Laboratory/Clinical Systems, Learning Management System (LMS), HR Benef Confidential s, Excel Spreadsheets/Forms/Reports, Firmware, Hardware, Tools and Test Racks.

Document Types Supported: Created, Edited, Enhanced, Reviewed and/or Used - Visio Business Process Flow Diagrams, Change Management Forms/Systems, Standard Operation Procedures (SOP), Work Instructions (WI), Statement of Work (SOW), Project Plans, Configuration Management Plan, Software/Technical/Detail Design Specification (SDS/TDS/DDS/DS), Application/Software Risk Analysis, Validation Plan, User Requirements Specification (URS), Functional Requirements Specification (FRS) and System Requirements Specification (SRS), Requirements Risk Assessment, Test/Qualification Plan/Protocol/Procedure/Specification, Trace Matrix Specification (TMS/TM), Various Gate/Check Points Check Lists, Test Case (Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) User Acceptance Testing (UAT), Evaluation/Ad-Hoc and Use Cases), Test/Qualification Reports, Validation Summary Report (VSR), Test Closure Memo, Software Release Communication Memos, Various Documents/Materials (for Projects & Program Managers, Testers, Analysts, Tech/Customer Support, Laboratory and Production Workers) and Gap/Risk Analysis (Forms, Documents and Reports with Suggested Enhancements to Product and/or Supporting Documents & Requirements).

PROFESSIONAL EXPERIENCE:

Confidential

Senior Software Quality Assurance Team Member

Skills Applied: Software Development Lifecycle (SDLC) Management (Quality), Business System Analyst / Architect, Management, Product Cost Negotiation, Requirements Gathering, Process Analysis / Creation, Quality Assurance Management (Creation and Delivery)

Responsibilities:

• Worked on several Quality Management System (QMS) SOP documents and templates.
• Supported the creation of Confidential ’s Security Management System.
• Participated in Confidential ’s agile process discussion.
• Lead Learning Management System (LMS) team in the identification and creation of user requirements.
• Lead Confidential in the LMS application / vendor evaluation selection process.
• Worked with vendors on price negotiation and SOW creation.

Software Quality Assurance Resource

Confidential

Skills Applied: Software Development Lifecycle (SDLC) Software Quality Assurance Resource, Test Engineer, Test Executer, Quality Assurance Reviewer (Test Cases and Requirements)

Responsibilities:

• Supported the creation and modification of CRI’s pre-test documentation.
• Created, reviewed, and approved test scripts within HP ALM.
• Added and updated requirements within HP ALM.
• Executed CRI’s test closure documentation.
• Reviewed and supported modified CRI’s QMS (SOP).
• Created a Report QSI (SOP) to address a CAPA finding.

Confidential

QA Manager / QA Engineer

Skills Applied: Software Development Lifecycle (SDLC) Management (Quality), Quality Assurance Engineer and Trainer (Creation and Delivery)

Responsibilities:

• Created process controls materials and provided guidance and direction to support the process controls being implemented for sprint release software validation.
• Worked with and instructed the team in Agile processes as well as supported the team during Scrum meetings.
• Learned new applications (SpiraTeam and DART System), created materials in support of a new application and conducted within MISO on the new validation type of application.
• Discussed processes with DART Management and Team Members in support of MISO’s quality directions/directives as they evolved as well as on quality as it related to the DART Management/Team.

Confidential

Senior Quality Assurance - Testing Consultant

Skills Applied: SDLC Management (Business and Quality), Technical Writer, Quality Assurance Engineer, Business Analyst, Testing (Adhoc/Evaluation and Formal) and Trainer (Creation and Delivery)

Responsibilities:

• Created and supported process control materials per governmental guidelines within the Teamcenter/Teamcenter NX application that would translate into procedures, standards, manuals, work instructions and materials for the creation of nuclear submarine components.
• Created and facilitated the creation of various quality/validation templates for planning, requirements, design, testing, go-give, ongoing support and periodic reviews.
• Reviewed, prior to approvals, the use of all finalized drafts of quality/ validation documentation.
• Supported change control process and various work orders blocks/CRs.

Confidential

Software Quality Assurance Manager

Skills Applied: SDLC Management (Business and Quality), Technical Writer, Business Analyst, Quality Assurance Engineer, Testing (Adhoc/Evaluation and Formal) and Trainer (Creation)

Responsibilities:

• Provided quality assurance guidance, and leadership to the Technology Integration and Implementation and Enterprise Technology Solutions group of our SDLC process and validation.
• Managed and supported SDLC validations efforts of the main custom application within our group.
• Improved the Validation Tool Kit (VTK) deliverables for SuccessFactors LMS product.
• Served as validation lead and supported/assisted in the management of SDLC processes, deliverables and quality budgets for Confidential from the beginning of the SOW to Go-Live.
• Worked within the budgets that was assigned to me while managing and coordinating with Client’s and GP’s cross-functional teams to assure project delivery.
• Assisted in the validation, management, facilitation and testing/verification of all items listed above as required to meet due dates and successful Go-Live(s) within Confidential and within the organization’s quality process and resources.
• Supported all CAPA items discovered during client vendor audits to support continuity with the pharmaceutical organizations that may have findings with our core SaaS product.

Confidential

Business Architect

Skills Applied: Business and System Analyst, Quality Lead, Business Analyst, Technical Writer, Testing (Documented Adhoc / Evaluation) and Trainer (Creation and Delivery)

Responsibilities:

• Provided and support to other business architects, IT members, and internal business departments within ASHP.
• Worked as an IT Program Director. Organized and implemented software development life cycle (SDLC) process and Six Sigma business level methods with the operations and technology departments as well as with ten internal ASHP business departments.
• Interviewed business departments for processes and requirements while building business process flow diagrams (high and low level).
• Guided the various departments in the creation of standard operating procedures (SOPs) and helped ASHP to understand the need for SOPs.
• Trained business architects in the concepts and guidelines of writing requirements as well in the collection of requirements.
• Provided suggestions, guidance, direction, and support when taking ASHP through a “solution-ing” process and when we discussed possible software and hardware options during process improvement activities.
• Provided instruction and rules for testing/verifying processes, tools, and applications to the IT department and various business departments.

Confidential

IT Project Manager / Tech Writer Support

Skills Applied: SDLC Project Management Support, Technical Writer, Business Analyst and Quality Assurance Engineer / Resource

Responsibilities:

• Responsible for the creation and completion of all SDLC project-related deliverables for various groups and departments.
• Provided support as a business systems analyst (BSA/BA)/systems analyst (SA), subject matter expert (SME), technical writer, test engineer, and test executer for validation within the SDLC process for GxP software, firmware, hardware equipment and business processes.
• Responsible for the creation, modification, and review support of business related documents such as SOP, work instruction, URS, FRS, TDS and various security documentation from a corporate and compliance perspective.
• Responsible for the creation, modification, review, and execution of validation deliverables such as IQ, OQ, PQ and UAT from a validated GxP perspective.
• Supported the remediation efforts of CAPA related events across multiple departments worldwide such as compliance, business, manufacturing, and laboratory.
• Responsible for providing as well as materials for various groups and departments.
• Provided guidance and assisted in the creation of our team’s SharePoint projects and deliverables sites with metrics on team’s projects, tasks, activities, and statuses.

Confidential

IT/IS Quality Assurance Manager / Quality Assurance Engineer

Skills Applied: SDLC Quality Manager, Project Manager, Business Analyst, Technical Writer, Quality Assurance Engineer / Resource, and Trainer (Creation and Delivery)

Responsibilities:

• Supported multiple projects in varying roles depending on size and resource availability within the SDLC process.
• Overall responsibility was to provide compliance guidance and for any project teams that were assigned to us while working hand and hand with the project team’s project manager to assure that there were no compliance issues when delivering systems for the various groups in the organization.
• As needed, supported department resource management and budgeting discussions surrounding project needs, deliverables.
• Provided to any new program/project managers on SDLC and ISPDM processes and general corporate SOPs from a compliance perspective within GAMP, FDA 21 CFR Parts 11 and 820 guidelines to assure that the appropriate project deliverables are designed and implemented for a project.
• Served as a part of the Change Approval Board and the Operational Readiness Review board for software and hardware changes.
• Performed project manager, business analyst as well as validation/test lead roles for GxP and Non-GxP applications when none existed in a project team for requirements gathering, validation, verification, qualification, and general testing activities.
• When resources were lacking, assisted in the creation, modification, review, dry runs, and execution of all validation deliverables such as IQ, OQ, PQ, and UAT on non-validated and validated GxP application systems and/or programs.
• Created and managed our IS/IT Quality Manager Teams SharePoint sites and provided ongoing reports with metrics on team’s projects, tasks, activities and statuses.
• Responsible for the creation and review support of corporate SOPs and work instructions from a compliance perspective.