SUMMARY

• Six Sigma Green Belt. Extensive experience as Director, Product Manager, Project Manager, QA Manager, Vendor Compliance, Risk Management, Infrastructure, CAPA, Complaint Handling, SAP Modules QM, MM, PP, HR, PLM,PI , Validation/ CSV, Extensive Quality/Compliance/Regulatory and Testing Management manual and automated experience for the Health Care, Pharmaceutical, Medical Device, P C Insurance and Telecommunications disciplines. Process Improvement skills utilizing ITIL, IEEE, and CMMI. Financial PeopleSoft, Hogan and McCormick Dodge.
• Highlight of 3 years as a Computer System Validation Specialist for Remediation for Schering Plough
• under a FDA Consent Decree.
• Health Care Exchange HIX
• CMMS Software Blue Mountain
• Managed several Product Conversions
• 21 CFR Part 11 Specialist
• Risk Mgmt. Assessment and Mitigation Specialist
• Process Improvement Processes implemented for Healthcare/ Medical Device/Pharmaceutical within current Infrastructure.
• Product Lifecycle Management, Supply Chain Strategic, Tactical and Operational Medical Device and Pharmaceutical
• CATS and TrackWise Med Device Software
• IEEE Standards 730, 830, 1012, 1059, 1028,1044 1061 Training on each and utilization of Standards
• Hospital audit and workflow remediation.
• Mentoring of Hospital Administration Staff.
• Business Analysis for Risk and Requirements
• 8 years' experience with CDMS, CTMS and CPM
• HIPAA Compliance/Code Set Electronic
• EDI X12 Transaction Sets 270/271, ICD 9, 276/277/835/837HIPAA 5010, 4010, also EPIC EMR
• Extensive IT Test Management
• Testing Process Assessments UAT, Database, Functional, Integration Test, Test/Use Case Design, Web Testing, SOA, Open Source Software
• CMMI Levels 1, 2, 3
• Change Management Implementation Release Management
• FACETS, MMIS Medicaid
• HP Quality Center 9.0, 10.0, 11.0 ALM
• Vendor Management Qualifications
• Quality Mgmt/Test Plans, SOPs, Requirements
• GAP Analysis of Processes/Procedures
• Creation of Validation Master Plans
• Sarbanes Oxley
• LIMS, Systems and Lab Equipment, SAP Scripts
• Internal Audit of CAPA Records, SOP's,
• OQ/PQ/IQ procedures and Validation Revalidation,
• GAMP-4 5, ICH, GXP, GMP, GCP, GLP
• ISO 13485:2003, ISO 14971, TS 16949
• Design of Training Programs/Sr. Trainer
• Staff Development and Mentoring
• Compliance/Regulatory Training
• KPIs, HR Training Records Dev/Mgmt
• Validation/Revalidation Systems/Lab IQ/OQ/PQ
• SOP/SOW Preparation and Training
• Developed Internal Audit Plans
• Data Profiling Quality Stage
• JAD Leader, Storyboards, RAD, ITIL, Agile
• Insurance/Whole Life, Term Life, P C, Auto, Reinsurance
• Strategic planning, Tactical Execution
• Data Mgmt/Cleansing/Data Access Strategy
• Risk Management and Mitigation
• ERP Implementations and Testing SAP
• Outsourcing Management
• Vendor Procurement/Management/Auditing
• System Design/Integration/Implementation
• Database Migration Conversion and File Migration
• Change Management various tools
• Methodology SDLC Implementation
• Customized and COTS SDLC Methodologies
• Risk Management and Mitigation
• ERP Implementations and Testing SAP
• Outsourcing Management
• Vendor Procurement/Management/Auditing
• PeopleSoft Billing and Accounts Receivable
• Hogan Software and McCormick Dodge Software
• SAP Modules QM, MM, PP
• CAPA Design, Internal Audit of CAPA Records, SOP's
• Strategic planning, Tactical Execution
• Data Mgmt/Cleansing/Data Access Strategy
• Methodology SDLC Implementation
• Customized and COTS SDLC Methodologies
• Served on Drug Safety and Surveillance Task Force
• Developed KPI's KSI's to measure and define employee success.
• Complaints
• Designed and implemented Change Management Processes
• Regulatory 510 Preparation/Submissions for Pre Market Approval. CAPA Complaints
• Defect Review Mgmt and Chairman Defect Review Board

Technical Summary

• Life Sciences Medical Device: GAMP, GxP, SOPs, SLA's, SOW's, Test Plans, QA Plans, OQ/IQ/PQ, FDA 21 CFR Part 11, 50, 54, 56, 312, 314, 510, 812, 814 Compliance, 806, 820, Regulatory PMA 510 LIMS, FDA QSR Quality System Regulations , Compliance, GxP, cGMP and cGLP, Audits, SOPs, Clinical Trial Systems, HIPAA Compliance, Audit EDC records, IEEE, ISO 9001, ISO 13485, ISO 17025, TS 16949 Validation, IQ, OQ, PQ, CAPA, CMMS Software Blue Mountain
• Environments: Client-Server, PC XP, NT, 2000 , UNIX, .NETOS/2, and HP 9000, Mainframe IBM and HP, Sybase, Oracle, SQL Server
• Testing Tools: Quick Test Pro, E pic EMR, HP Quality Center 9.0,10.0 and 11.0, JIRA, Load Runner, Rational, Data Profiling Tools, SOAPUI, Tracker, FitNessee, Cucumber, TestHarness, Open Source Net Beans.
• Software: CATS, Track wise, Open Source, LIMS, Documentum, Business Works, Rally, Q E Query Tool, MS Access, ConVera, Epicentric, Rational Test Tools Requisite Pro, ClearCase, ClearQuest , Tracker, Crystal Reports, MS Office Tools, Microsoft Project, Visio, Case Tools, Database Tools, HP Mercury Quality Center Versions 9, 10 and 11.0 ALM , JIRA, Facets, Visual Studio, SAP QM/PP/MM, VMware Desktop, SharePoint, PeopleSoft, Hogan, McCormick Dodge, Risk Management Plans
• Methodologies: SSAE 16, SAS 88, 78, 70, Model Office, GAMP-4, GAMP -5, Sarbanes-Oxley, RUP, CMM, SUMMIT D, ISO, IEEE, customized SDLCs, PMBOK, V-Model, SAP, Agile Scrum and SOAPUI , Summit-D, ITIL, Storyboarding, Use Cases, Six Sigma Green Belt, SOA

PROFESSIONAL EXPERIENCE

Confidential

• Worked with Users and Authored 156 Requirements
• Authored System Project Plan, 2 Separate Master Test Plans, Traceability Matrix, Test Incident Reports Creation and Resolution and Re-execution ,Test Validation Summary Report, Project Summary Report
• Performed Risk Management Assessment and developed Risk Mitigation Plan
• Managed the creation of 200 Test Cases with over 4000 test Steps in the revised Biogen Idec format
• Extensive collaboration with Vendor Thermo Scientific during preparation, installation of the COTS Upgrade and Validation Execution.
• Analyzed created Validation Reports during execution for accuracy
• Responsible for Test Team resources Planned and Budgeted
• Maintained Documentation Repositories - SharePoint and myCIMS

Confidential

Quality Assurance/Test Manager

• Worked with Healthcare entities to set up Healthcare Exchange HIX
• Worked with Users and Authored Requirements
• Distilled and delivered relevant content for project Communication Plans
• Created Master Test Plan
• Responsible for Project Team resources planned and budgeted
• Analyzed created reports for acceptability
• Configured Program for Quality Center 11.0
• Created Dashboard Metrics
• Primary liaison between PMO and the IT Line of Business as it relates to the quality and testing.
• Liaise with Onshore/Offshore Personnel for Project status and metrics.

Confidential

Manager Quality Assurance Compliance Project Management Consultant

• Performed GAP analysis on the CAPAs prior to audit. Items considered were the relationship to the Warning Letters and the Observations, content of the DHR, DMR and the documentation for GDP. Recommended and implemented Process Improvement Processes. CATS Software.
• Audited non-compliant complaints and Medical Device reports and correction of related CAPA's. Primary focus on Root Cause Analysis and managing the investigations. Created excel Auditing spreadsheets. documented salient information for correction and providing corrections. All corrections were compliant with regulatory standards. Performed Trend Analysis on 20 manufacturing complaints and utilized the 5 Why's, Decision Tables and Fish Bone Diagrams for presentation of facts.
• Prepared documentation for defining Corrective and Preventative actions
• Member of CRB, Compliant with GAMP-5.
• Enforced Change Management process for required CATS Software total of 30 Change Management Requests
• Audited Supply Chain for Manufacturing of 2 Spinal Products
• Focused on the Production, Packaging and Distribution use of the Products as related to Field failures documented in Complaints and CAPAs.
• Focused on the CMMS Software utilized for Work Order Mgmt, Inventory Control and System Integration with CATS Software.
• As time permitted worked with the Complaints.
• Responsible for processing new Complaints and reviewing Complaints for remediation.
• Reviewed complaint files and closed as appropriate
• Received product complaint information and made decisions regarding entry into the complaint database and whether to consider for MDR reporting
• Reviewed and assessed patient medical records for pertinent complaint information
• Authored investigation reports Completed
• Strict adherence required to ISO 13485,21 CFR 820/806 and utilization of checklists

Confidential

Project Manager Testing

Project Manager

Single Point of Contact SPOC for IQ/OQ Infrastructure Simplification Project. Main focus was Oracle and SQL Server IQ/OQ, with 4 other Technology areas under review. Simplfied Templates, Test Cases and overall testing, submission and approval processes for GxP Compliance. Compliant with GAMP-5 Utilized SharePoint. Extensive knowledge of current Infrastructure required. Completed

Confidential

Prepared Assessment on the feasibility of establishing 3 2013 Medicare Part D Claims Processing Centers with Off Shore and On Site RX processing models. Completed Utilized SharePoint. Provided guidance in the development of the COE. Completed

Confidential

Assigned to Proclaim Project. Managed all Testing activities and staff assigned to the Project. Included 3 production releases. Generated Change Management documents for enhancements. Utilized Quality Center 10.0, Epic EMR and SharePoint. Interaction with varius Vendors. Prepared ground work for ICD-10. Focus of Project was on Financial applications relating to consolidation for yearend reporting for claims and reserves. Completed

Confidential

• Performed Supply Chain Audit of POU Point of Use pill dispensing system in 1 hemodialysis clinic. This was an operational audit tracking the loading of the machine, dispensing, utilization and audit of the reports on utilization.
• New Dialysis Treatment System Falcon 2.0. Product Management responsibility for the Orders module 13 Order Types . Preparation of the Testing Approach document, creating Traceability Matrix in Quality Center 11.0, creating Test Cases, execution and defect management and resolution. Agile environment utilizing Rally Agile Software. Full Product Lifecycle Management process.
• Gathered requirements and developed functional business specifications for test script development. Utilized SQL, SharePoint, QC 10.0, ISO 13485, TS 16949 and Agile SDLC. Completed

Confidential

Sr. QA Specialist, Quality Center 10.0 and 11.0

• Subcontractor for Hewlett Packard HP Product Lifecycle Management
• Expert Specialist responsible for the installation, customization and configuration of HP Quality Center 10.0 and 11.0 ALM Sprinter and Business Processes and implementation.
• Trained and mentored State of MI employees in functional testing and Test Management
• Authored a Best Testing Practices document, Root Cause Document, Mapping from Excel to QC 10.0 for Requirements, Test Cases and Defects. Also, configured JIRA to accept duplicate defects.
• Project Team member of a very large team consisting of State of MI employees and 30 HP consultants. Utilized SharePoint, Remedy, Quality Center. Member of the COE Team, developed templates. Required extensive knowledge of Infrastructure.
• Attended Training on following IEEE Modules. Utilized the Standards 730, 1012, 1059, 1028,
• 1044, 1061. Compliance and training on CMMI 3
• Implemented Process Improvement Process for Defect processing and resolution.

Confidential

Sr. Testing Manager/ HIPAA 5010 Project

• Created HIPAA 5010 Test Management Plan for EDI Eligibility Transactions 270/271 and 820, 834,835/837 I, P, D.
• Subject to HL7 data standards
• Heavy use of the Model Office process, all 3 Tiers. Worked with Process Gaps and participated in simulation.
• Extensive testing management of Change Management Requests for enhancement
• Included processing for MMIS Medicaid via HIPAA 5010. 800 Series EDI Transactions
• Test Management Plan Was created as a roadmap for all future EDI Transactions.
• Worked with Sales and Marketing team in defining Requirements for Sales Quotas and Territories.
• This was required because of the specialized interfaces and data that had to tested.
• ITS documentation for claims processing. Addressed Trading Partners and Clearing House issues.
• Created on boarding training program for off-shore resources.
• Created and managed to the risk based Testing Work Breakdown Structure
• Authored Quality Procedures and Checklists.
• Defined and managed configuration for Quality Center 10.0. and Sprinter.
• Guided set up of QTP 10.0 for Regression Testing
• Visual Basic and Visual Studio tools were utilized by development. Managed test case development in agile environment. Utilized FitNessee and Cucumber. SOA, .Net Web Testing utilizing Java, Open Source Net Beans and MySQL. Utilized SharePoint.
• Interface testing included with EPIC EMR and Revenue System