Summary

Extensive experience in the following Disciplines Commercial and DOD :

• System Integration
• System Engineering
• Business Analysis
• CMMI-1-3/QER
• SQA Audits Government, FDA, Commercial
• Continuous Process Improvement CPI
• Program/Project Management hands on
• QA Test Management-Manual-Automated hands on
• Configuration Management
• SDLC/PDLC agile, iterative, maintenance Small, Medium and Large Projects - full lines of documentation
• Risk Management/Defect Management-CAPA
• Metric Collection/Analysis
• Root Cause Analysis
• Change Management/Change Control-CCB/ERB
• Issue/Escalation Process
• GxP 21-CFR-21

Managed, Developed and Implemented the following utilizing the defined disciplines above:

• CMMI/CPI Process/Methodology from Conception to Deployment-QSR Audits/SCAMPI
• Establish/Managed New/Adhoc QA and PM Departments
• Automated System/Software Test Environments Utilizing Automated Test Management Tools, GUI Automated Script Capture Tools and Load/Performance
• Process Improvement Guidelines with emphasis on SOPS-Root Cause Analysis, and Lessons Learned
• Created Use Cases/Test Cases/Test Scripts-Automation-Manual
• Product/Software Development Lifecycles-Software Development Life Cycle
• System/Software Requirement Management Process DOORS, RequisitePro, Caliber, TFS elicitation-decomposition-final requirement validation point
• Pharmaceutical IV V guidelines and Document Control
• Manage JAD sessions, define System Engineering requirements
• Perform Integration Analysis to determine impact to baseline functional, schedule and budget
• Pharmaceutical Corrective Action Preventive Action CAPA -21CFRPart11 IV V , 211,210
• Photogrammetric Imagery Analysis on Terrestrial, Underwater, Air Craft and other remote systems
• Project Management Guidelines, Reviews, Reporting and Issues/Risk Resolution
• Financial Systems
• Department of Defense Projects 5001 2, TEMP, DAG, IV V, PM, QA, Business Analysis

Technical Summary:

• Platforms: IBM PC, Mac, UNIX, SUN Solaris, Web Servers-Cold Fusion.
• Document/Requirement Management Tools: QSS-Doors, icConcept-RTM Workshop, Rational Req Pro, Borland CaliberRM, JIRA and TFS.
• Process Control/Project Management: Six Sigma Lean, Continuous Process Improvement CPI Capability Maturity Model SEI , Rational's-RUP, IEEE-1298 etc ISO 9000, PMI, IBM Summit Ascendant,, AIM Oracle Methodology, DOD 5000.1-5000.2, Defense Acquisition Guide UML, TFS-Microsoft Visual Studio
• Audit Processes: IV V Audit Process DOD , DAG, FDA GxP and 21 CFR Part 11-820, CMMI SDLC , ISO 9000A, IEEE, RUP, SOX, DOD Auditing using 8500.2 security controls ISS-Information Assurance
• Operating Systems: Windows XP, UNIX, Redhat.
• Languages: C , SQL , TSL Automated Test Script Language and HTML.
• Databases: Oracle 11.0 12.0.6, Informix and Sybase
• Case Tools: ORACLE CASE, IDEF0 Modeling.
• Configuration Mgt. Tools: Clear Case, Change Man, Harvest, Borland Star Team and PVCS.
• Network Manager Tools: DEC Polycenter Manager on NET VIEW, SUN Solaris NET VIEW, HP OPENVIEW, Network Node Manager.
• Automated Performance/Test Tools: Load Runner, Win Runner, HPQC-ALM, Quick Test Professional, Rational Robot, Rational Test Manager, Rational Functional Tester, Rational Manual Tester, ClearQuest, Compuware-QADirector, QARun, QA Load, and RALLY Agile Tool and TFS.
• FDA Compliance: 21 CFR Part11 211,210 , GxP, CAPA and GAMP.
• Certifications: Certified Software Test Professional, CMMI Certification
• Pending: PM/SCRUM Master-Agile Master

EXPERIENCE:

Confidential

Sr. CMMI/CPI/QA/PM Consultant to Department of Defense

• CMMI Process Manager responsible for moving the division from CMMI level 1 to CMMI level 3.
• Applied standard QER CMMI techniques to assess the as is state of the division and report results to division director. Performed SCAMPI C/War Room assessments
• Developed and presented the road map for moving the division towards CMMI 3.
• Authored and Implemented the Product Development Life Cycle PDLC based on Concept to Delivery. PDLC in order to support a Maintenance/Agile/Regression life cycle.
• Authored ALL the supporting PDLC/SDLC documents to include the ML2/ML3 CMMI Processes and SOP's. Implemented and
• Restructured HPQC ALM in order to support the business model.
• Re-wrote the Help desk work flow and introduced training to eliminate the division level issues.
• QA Manger for the department was responsible for the following:
• o QTP Process and implementation, HPQC-ALM Process and Implementation, TFS Implementation, Manage the everyday Test Activities, and developed/implemented the QA Project Plan.
• Developed the Master Schedule for the program and implemented project guidelines and Estimates. Project Manager on Transformation Project from FMIS ETL to SSIS/SSRS.
• Authored the following proposal documents:
• o Risk Management Plan, System Engineering Plan, QA Test Plan, Configuration Management Plan, Process Improvement Plan, Project Management Plan and Defect/Issue Management Plan
• Sr. Business Analysis -Requirement Definition, decomposition, management RTM and Use Case, Test Case development TFS

Confidential

Project Management

• Provide consulting services to personal in key positions within multiple companies that have requested mentoring/training on the following:
• o Project Management Project Plans, Project Estimation, Risk Management, and Metric Collection/Reporting , System Engineering, Escalation Process, Change Management, SDLC, Automated Tools, Process Improvement, SQA, and QA Testing.
• Present mentoring approach to Sr. Management and gain their approval.
• Evaluated and provided feedback to these key personal on best practice approaches based on assigned tasks.

Confidential

Sr. Manager/Project Management

• Oversee Process Improvement through Audits and Root Cause analysis in support of Architecture, Engineering and QA Testing,
• Managed/Implemented Training guides for Metric Analysis, Requirement Management, Automated Tools, and SDLC Processes agile .
• Created SQA Audit Guide for Validation of adherence to the SDLC in order to support Process/Quality Improvement SixSigma .
• Generate Project Metric Reports.
• Created Full SDLC Requirement Management Process via SOP's in support of Agile Test Process.
• Develop Risk/Issue Management Process in support of the Change Control Board.
• Managed the Implementation of JIVE social networking tool .
• Managed the re-structuring of SharePoint directory to match the SDLC. Defined the HPQC Process for the Management of QA Testing.
• Developed Configuration Management Process from Configuration Items to Build/Release.
• Managed the COMCAST Tool selection effort. test tools, requirement management, defect management, change management in support of an Agile SDLC.
• Tool sets: DOORs, QTP, JIRA, HPQC-ALM, JIVE, Subvergence, SharePoint, and MS Project.
• Provided CMMI Guidance.

Confidential

Sr. PM Consultant

• Supported Integration, Product and Parallel Test effort by Designing/Authoring the Overall Data Coordination Approach Document.
• Managed system requirement
• Managed Configuration Management Team by defining the Build Release Process and mentored on CM Practice CI List throughout the application lifecycle.
• QA Manager-hands on
• Tools: ClearCase, QTP and LoadRunner

Confidential

Sr. PM Manager QA Manager

• Using the Oracle AIM/CMM methodology moved an Adhoc ground up QA organization to achieve a sustainable repeatable process.
• Managed an On-Shore/Off-Shore QA organization during the migration from Oracle R11 to Oracle release 12.0.6.
• Sized the Total QA Migration effort and all milestones, per the PM/QA Project plan.
• Created the following Documents/Processes
• o RTM with full Traceability, Defect Reporting and Metrics collections points based on SixSigma , Independent Audit Process, Script Writing Convention's, Project Plan, Triage Process, Test Strategy/Plan, Load/Performance Plan
• Defined Process around Quality Center attributing Test Scripts, Requirements and Defects , Communication Plan, Action Item Plan, QA Audit Plan and Automated Test Process.
• Used QC and QTP to manage and create Test Scripts.
• Implemented System Engineering Guidelines.

Confidential

Director of QA/PMO

• Manage the Quality Assurance group and the Project Managers with emphasis on Process Engineering and Process improvement .
• Managed merger activities PM and Financials
• Moved the QA practice from manual efforts to automated approach,
• Author ALL QA deliverables and Processes defect Process, Build/Release, QA Project Plan etc. ,
• Move the company towards Process Control/SOP's Software Configuration Management, Corporate SOP's, Work Request/Ticket Resolution Process, Communication Plan etc. .
• Managed the Product Management group during the Concept Phase to include Requirement Management and defining roles of the PMO office in support of this effort.
• Responsible for defining commonality between silos within Macrovision for the purpose of reducing redundancy, to create/improve QA repeatability, create common PMO/PM practices, and automate PMO/PM practice with common tool sets.
• Used QC and QTP to manage and create Test Scripts.

Confidential

Sr. QA Test Manager/SQA

• Managed QA Audit Process IV V , build a QA Test Environment, and maintain adherence with CMMI and DOD5000.1/2 process controls.
• Developed all SLC controls QA Processes in support of software delivery cycle.
• Managed a Test Team /Designing the overall QA test methodology.
• Authored/designed the following QA support documents:
• o Test Strategy, Test Plan, Defect Management, Root Cause Analysis, Escalation Process, Issue Tracking, Configuration Management Doc., Metrics Analysis, Requirement Management Plan, Risk Plan, Build/Release and Process Script/Procedures templates Automated/Manual .
• Manage the Developed the process/methodology in support of the implementation of Automated Test Tools CaliberRM, StarTeam, TestDirector, LoadRunner and Rational Tool Suite .
• Performed validation using 8500.2 security controls Information Assurance/ISS .
• Metric collection points and analysis was based on DMAIC approach to defining and collecting metrics.
• Responsible for defining customer Requirements and transferring to technical concept documents.

Confidential

Sr. PM/QA Manager

• Manager of Credit Card Services with the responsibility of Restructuring and Managing a team of QA Engineers On-Shore Off-Shore model .
• Managed Testing Activities:
• o Accomplished with the use of TestDirector/WinRunner and CMM Level 2 Process.
• Tasked with moving the QA/PM Process to a CMM Level 3.
• Established a QA Release process and Configuration Control Board. Established Root Cause Analysis process.
• Collected and Maintained Defect Metrics for the purpose of process improvement.
• Performed audits of the SDLC in support of adherence SEC compliance regulations.
• Created QA Project Plan defining Small, Medium and Large development effort.
• Manager of QA/PM merger activities between JPMorgan and BankOne. Received training on Green Belt SixSigma .
• Testing Tools: QTP, LoadRunner, WinRunner, and Quality Center.

Confidential

Sr. PM/QA Consultant

• Manager of the QA Automation Pilot and the Corporate Software Life Cycle Process/Methodology.
• Managed and directed a group of Sr. SME's.
• Designed a ground up approach for QA Test, QA/PM Process, SDLC, Enterprise Audit Approach, and Methodology automated/manual process in support of the CMM level 2 for an ING enterprise implementation.
• Developed and performed the GAP Analysis
• Authored the Automated Requirement Effort, Developed the Project Plan using IBM Summit
• Established the Training for the QA group and Authored the Test Plan automated/manual effort , SOP's, Test Strategy, and QA release document. Test environment was supported by the following Automated Tools:
• Quick Test Professional, LoadRunner, WinRunner, and TestDirector. ING was moving to a SixSigma and therefor processes, documentation and metrics were based on the DAMIC approach.

Confidential

SR. QA Manager/Project Manager

Consultant

• QA Manager/Project Manager on the Enterprise CAPA Corrective Action and Preventive Action Audit Project.
• Managed/developed the following:
• SLC Audits and Reviews, Part 11 Assessment, Defined SDLC, Established the SDLC Controls via the Configuration Management Plan,
• Authored the following deliverables:
• CMP, FRS, Validation Plan, Test Plan, Test Process, Staffing Plan, Change Control Process, Code Review Plan, Project Plan, OQ, PQ, IQ, DOORS Implementation and SOP's. Maintained adherence to GMP, 21 CFR Part11 and the Software Quality Assurance Plan SQAP via FDA audits.

Confidential

Sr. Consultant/System Engineer

• Managed JAD Sessions in order to Define User Requirements for the Bovine Spongiform Encephalopathy BSE and Transmissible Spongiform Encephalopathy TSE Project.
• Established the Software life Cycle for the project, to include full document support in support of QA Validation. .
• Mentored/Implemented System Engineering and System Integration principles.
• QA/ Audit Validation Manager supporting Global Compliance Auditing in developing the ART System Audit Reporting Tracking system . integrate all GxP Audits into one logistical Automated Process.
• Authored the OQ, PQ, IQ, FRS, URS, SLC Test Plan, System SOP's and the Validation Plan.
• 21CFR Part11 Validated System.

Euro Healthview Corporate -Pharmaceuticals

• Managed the development a ground up TQM Total Quality Management environment for Euro Healthview.
• Defined/Developed the Process and Methodology from Conception to Deployment
• Implemented the following Methodologies:
• Defect Management, Change Control, Version Control, and Risk Management. Created All the Requirement Templates, Testing Templates, QA Template, Risk Template, Proposal Template, Project Plan small, medium and large effort , Statement of Work Template, QA Audit Check Points and QA Review Check Points.
• Developed the SOP's to define Processes and Methodologies.
• All processes and methodologies follow ISO9000 and IEEE Standards.
• The aforementioned processes and methodologies adhere to and are designed to pass an FDA audit using 21CFRPart11 as the audit guidelines.

Confidential

Independent QA/PM Consultant

• Member and Advisor to the Quality Management Council. The QMC represents the 5 five major divisions of Merck and was
• Managed , design and implement a unified QA Process Methodology.
• Performed an Audit of Merck's current Standard Operating Procedures SOP , Quality Standards QS and Software Life Cycle SLC . Based on the QA Assessment, updated the SOP's, QS's and the SLC.
• The SDLC was designed using Rational's RUP process model.
• All Templates, Documents and Standards followed the FDA guidelines of 21 CFR 11, FDA-QSIT in support of GxP environments.
• Advisor to the IS department in support of the migration from True to ClearCase CM Tool .

Confidential

Independent QA Consultant

• Managed the depth study of Cigna-Intercorp's Testing Methodology and QA Process's.
• Performed a Proof of Concept to Verify/Validate TestDirector and WinRunner's ability to automate and manage Intercorp's Regression scripts.
• Developed all QA Support Documents

Confidential

Sr. Consultant QA/PM Manager

Managed/developed Quality Assurance Program and Structured Testing Methodology at First USA. Defined QA Verification and Validation Environment audit guidelines and process , Check Points, Audit Points, and associated documentation. Designed and wrote the Test Strategy, Test Plan, Business Document, Technical Document and the Functional Documents. Implemented iterative approach to ALL phases of testing based on business evaluation and GAP analysis. Involved in mentoring business groups on the benefits of adopting QA Processes, Verification and Validation Methods, Structured Testing Methodology and Implemented Automated Testing using WinRunner and TestDirector.

Confidential

QA PM/Validation Manager

• Managed restructuring an existing Test Integration Environment that was focused more on an Adhoc approach to testing.
• Implemented an Automated Test Approach WinRunner, TestDirector and LoadRunner in order to eliminate manual regression testing and to move EMAX towards repeatable processes.
• Authored the Project Plan, Created a Build Release Process to control and understand Software releases to QA.
• Structured and implemented an Isolated Test Environment in support of Verifying and Validating applications.
• Defined the PM/QA Work Breakdown Structure.
• Designed and wrote the Requirement Documents and templates.
• Supported are the following: NT- Two Tier /Three Tier, UNIX, Isolated Test Environment, JAVA Web Server and Robotics. Applications designed in PowerBuilder, HTML, and JAVA.
• All processes and methodologies adhere to and withstand FDA scrutiny, based on 21CFRPart11 per Audit guidelines.