JANET E. MOORMAN

*** ******** **, **********, ** 28409

CELL: 225-***-**** ac7dv3@r.postjobfree.com

Consultant serving the Pharma Life Sciences, Medical Device and Healthcare industries.

Corporate career with BCBS of NJ and Beneficial (Finance, Credit/Life, P&C Insurance)

BA, Six Sigma Green Belt. Strong Validation experience

SUMMARY:

Extensive experience with FDA Regulations, ISO Standards, IEEE Standards and OSHA Regulations. Highly motivated professional who communicates extremely well with all levels of management as well as outside vendors. Senior Quality Engineer/Manager with an extensive background in Pharmaceutical and Medical Device quality control, CSV, manufacturing and Complaint Investigation, Handling and Remediation.

Experience with ERP systems including SAP and JD Edwards.

6 years of experience working directly with CAPA and over 15 years of experience working with Auditing of GXP Compliance, SOP’s, Validation, Validation master plans, Vendor Compliance, Risk Management, LIMS, ITIL, IEEE and CMMI as well as Regulatory preparations/submission.

TECHNICAL SUMMARY:

Risk Based Testing: Extensive use of Test Method Validation (TMV) as a risk based process throughout testing process on site, on shore and off shore for multiple client sites

Compliance: Life Sciences & Medical Device: Data Integrity, GAMP, GxP, SOPs, SLA’s, SOW’s, Test Plans, QA Plans, IQ/OQ/PQ, FDA 21 CFR Part 11 and Annex 11, 50, 54, 56, 312, 314, 510, 812, 814 Compliance, 806, 820, Regulatory PMA 510, LIMS, FDA QSR (Quality System Regulations), Audits, SOPs, Clinical Trial Systems, HIPAA Compliance, Audit EDC records, IEEE, ISO 9001, ISO 13485, ISO 17025, TS 16949, 11607, 14971 Validation, IQ, OQ, PQ, CAPA, Complaints, NOE, EOE, CMMS Software (Blue Mountain), GAMP4 and 5, Labeling and UDI, Data Integrity

Environments: Client-Server, PC (XP, NT, 2000), UNIX, NETOS/2, and HP 9000, Mainframe IBM and HP, Sybase, Oracle, SQL Server, PLC within Manufacturing

Testing Tools: Quick Test Pro, Epic EMR, HP Quality Center 9.0, 10.0, 11.0 and ALM, JIRA, Load Runner, Rational Tools, Data Profiling Tools, Tableau, Looker SOAPUI, Tracker, Track Wise, FitNessee, Cucumber, Test Harness, Open Source Net Beans, Selenium, Minitab, GD&T

Software: SAP, JD Edwards, CATS, CATS Web, myCIMS, Open Source, LIMS, Documentum, Business Works, Rally, Q&E Query Tool, MS Access, Convera, Epicentric, HP (Mercury) Quality Center (Versions 9, 10 and 11.0 [ALM]), Rational Test Tools (Requisite Pro, Clear Case, Clear Quest), Tracker, Crystal Reports, MS Office Tools, Microsoft Project, Visio, Case Tools, Database Tools, JIRA, TrackWise. Facets, Visual Studio, JD Edwards, SAP QM/PP/MM, VMware Desktop, SharePoint, GeoDIS, eDoc, PeopleSoft, Hogan, McCormick Dodge, Risk Management Plans, MS Project Server, Selenium,

Methodologies: SSAE 16, SAS 88, 78, 70, Model Office, GAMP-4, GAMP -5, Sarbanes-Oxley, RUP, CMMI II - V, SUMMIT D, IEEE, customized SDLCs, PMBOK, V-Model, Waterfall, Agile (Scrum), Summit-D, ITIL, Storyboarding, Use Cases, Six Sigma Green Belt, SOA, COTS

TECHNICAL EXPERIENCE:

Senior Computer System Validation Specialist April 2018 to August 10, 2018

Dendreon Union City, GA

Key CSV for Datata Migration of UL Learning Management System (LMS) from source to target system in Union City. PA.

Authored Validation Plan, Data Migration Plan, Requirements Based Risk Assessment, eight Final Qualification Summary Reports and Final Project Summary Report.

Authored Test Plans and Test Scripts forUAT, IQ, OQ, DM and PQ.

Liasion with Vendors and their activities’

Monitored Data Integrity Standards for FDA Compliance

Strict adherence to FDA 21 CFR Part 11, GAMP 5, ISO 13485, PMBOK, SDLC V-Model

Independent Consultant, Project Manager

March 2017 – March 2018

Confidential Client

Implementation of new data warehouse.

Large scale Data Migration for 7 years of data.

Preparation of movement for data files for offsite storage.

Managed retirement process for previously used data warehouse.

Validation Expert/PM (consultant)

June 2016 – December 2016

Sanofi Pasteur

Swiftwater, PA

Data Integrity Assessment Critical for upcoming FDA Audit. Critical for SOP’s and Validation of Lab Systems.

Designated Compliance Expert for Canadian and US Dossiers Manufacturing and Clinical Trial Software.

Retrospective Validation of Procal v5, Beckman Cal, DAGS, Empower, PI Historian, PICK DIR, Track wise, Galaxy, ProficyCM, iAttend, SAP US - Modules = Product Life Cycle Management, Quality Management, Materials Management, Production Planning, Human Resource Mgmt, Project System, FICO, Process Integration. Payroll

Agile SDLC utilized with Scrum Meetings.

Review and preparation of Validation Dossiers for legacy Systems and Applications in preparation for Validation Transition Project.

Change Management Board Member - Processed and provided Approvals for major and minor Change Management Requests via Track Wise. Required GXP, 21 CFR Part 11, 210, 211 knowledge.

Managed Track Wise for Complaints, NOE, EOE

Extensive investigation and validation skills required.

Validation of numerous SOP(s) and Validation documents for accuracy.

Validation of documentation with manufacturing facilities.

Required knowledge of IQ, OQ, PQ processes. Extensive knowledge of SOP’s preparation and content analysis required.

Responsible for Dossier Artwork.

Extensive use of the knowledge of 21 CFR Part 11 and 820, ISO 13485, GxP, cGXP, GAMP4 and GAMP5.

Utilized several document repositories: GeodIS, GeodIS+, QeDocs, SharePoint, Track Wise 7 and

QA/Testing Manager/PM (consultant)

October 2015 – April 2016

TMG

Jessup, PA

Project Manager for 30 vendor resources (4 Vendors) for all QA and Testing (Manual, Automated, Performance, EDI) for Systems Integration testing relating to Medicare and Medicaid.

Designated owner of HP ALM. Implemented several new fields in Defect Module to significant metrics.

Data Migration of stored records for CMS MOMS.

Modifications to HP ALM to be robust for Account Management, Defect Management (Root Cause) and Dashboard Metrics for Test Cases, Scripts and Defects.

Implemented QMS into a testing organization with no Quality Standards in place.

JD Edwards for some Operations and Finance modules

Designed implementation process for Center of Excellence. Chaired implementation Steering Committee.

New initiative implementations. Primary was building data integrity into management of data files as Medicare is a government contract. Built complete, consistent and accurate data processes. This process implemented with test data and Production data monitored.

Conducted intensive Testing and QA training.

Agile SDLC and acted as daily Scrum Master.

Extensive preparation, presentation, leadership and Observation responses of HIPAA/Compliance/QA Audit activities by external auditors.

CMS MOMS Program for TX, MT, IL.

Applied Medicaid MECT Toolkit and Medicaid MIDA Toolkit.

Managed Testing and Implementation of IVR Application (5 Sites) – Vendor Nuance.

Management of 6 major Projects and day to day account testing.

Managed six different Team Leads.

Prepared estimates and managed significant software upgrades.

Authored Functional Requirements Specification and implemented. Initial use in TMG.

Documentation/Guidance/Training for Software Verification/Validation.

Converted ALM to work stream structure for Accounts.

Facets, EDI 200X and 800X (H, I, P), Selenium, UFT, ALM, Jira, Six Sigma and Minitab

Followed strict OSHA Standards in the workplace. Trained staff on OSHA Workplace Standards

Sr. CSV Engineer/PM (consultant)

April 2015 – June 2015

Fresenius

Waltham, MA

Lead for this Global Implementation of PTC Wind-chill 10.2 COTS Package.

Ensured compliance to 21 CFR Part 11 (Annex 11) and all EU Standards and Guidance Documents.

Authored all Validation deliverables; i.e. Validation Plan, Risk Analysis, 21 CFR Part 11 Assessment, Test Summary Report for OQ/PQ, Traceability Matrix

Collaboration with Business and IT Teams as a new server was installed.

Implemented Software Validation techniques for Wind-chill.

Managed UAT Team and trained on the use of Wind-chill 10.2.

Agile SDLC and daily Scrum Meetings.

Six Sigma techniques and Minitab for statistical reporting.

Sr. Quality Engineer/PM (consultant)

November 2014 – January 2015

Zimmer

Warsaw, IN

Audit for of CAPAs for FDA Audit, Processed Complaints, DMRs, and DHFs.

Retroactive examination of NOEs and EOEs to ensure CAPAs issued were valid.

Revised formatting of Packaging Label to conform with Regulations. Approved all Artwork.

Review and preparation of all 175 CAPA’s relative to received FDA 483’s.

Extensive interaction with CAPA authors to enhance steps taken on Risk Identification/Mitigation.

Track and Trace Packaging, 483’s were received on this. Authored SOP for Track and Trace.

Customer interaction as required in regard to CAPA issues. As a result of CAPA investigation supported manufacturing (GXP) for components, packaging, labeling and adherence.

Ensured adherence to all GXP Compliance practices and Complaints also reviewed on Track wise.

Data Integrity in data files was monitored.

Interaction with CAPA teams for the completion of Supporting Documentation, 5 Why’s.

Fishbone Diagrams/ documentation of Risk Analysis/Mitigation Strategies.

Extensive review of Compliance with ISO 13485, 21 CFR Part 11 and 21 CFR Part 820.

Managed staff of 6 for this assignment and Trained CAPA Team on Track Wise.

Authored IQ, OQ, PQ documentation to facilitate CAPA closure process.

Handled Complaints on Products - Initiation through Arbitration.

Member of Complaint Arbitration Board.

Utilized Track Wise.

Testing Manager (consultant)

June 2014 – September 2014

Biogen

Cambridge, MA

Provided day to day Leadership of the Achievement of Project Deliverables and Milestones for Testing Activities for the Validation (IQ, OQ and UAT) of the Watson LIMS Upgrade 7.4.2.

Agile SDLC and held daily Scrum Meetings.

Extensive application of GCP and GLP compliance.

Supported Users for creation of 156 Requirements.

Supported users in the identification and mitigation of RISKS in the Requirements Document

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.

Managed and Authored OQ and PQ test scripts for SAP QM and IM modules for SAP.

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.

Several incidents occurred for defective Track and Trace process. Corrected and implemented revisions.

Extensive collaboration with Vendor Thermo Scientific during preparation, installation of the COTS Upgrade and Validation Execution.

Authored and Managed Project Plan and Scheduling.

Responsible for Test Team resources planned and budgeted.

Enforced GxP Compliance (21 CFR Part 11 (Annex 11) and Part 820 for IQ, OQ and PQ Script Compliance. Responsible for labeling Compliance and UDL formula.

Tested PLC Compliance for microcontrollers within Manufacturing.

Maintained Repositories – Track wise, SharePoint and myCIMS

QA Test Manager (consultant)

March 2014 – May 2014

BCBS of MA

Boston, MA

Engaged to manage project execution and delivery, providing day-to-day Project leadership for the achievement of Project Deliverables and Milestones for the Enterprise Provider Testing Program.

Agile SDLC and held daily Scrum Meetings.

SOX Compliance, HIPAA Compliance.

Worked with Users in refining Requirements.

Worked with users in the identification and mitigation of RISKS in the Requirements Document.

Distilled and delivered relevant content for project Communication Plans.

Authored Master Test Plan.

Responsible for Project Team resources planned and budgeted.

Analyzed Authored reports for acceptability.

Configured Program for Quality Center 11.0.

Authored Dashboard Metrics.

Utilized MS Project Server.

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.

Managed 7 resources on this assignment.

QA & Compliance Expert/PM (consultant)

April 2013 – July 2013

DePuy Synthes/Johnson & Johnson

West Chester, PA

Responsible for site CAPA Program. Included PA sites, Eastern/Western Europe and Japan.

Performed GAP analysis on the CAPAs prior to audit.

Recommended and implemented Process Improvement Processes. CATS Software.

Identification and mitigation of RISKS within the Requirements Document.

Audited non-compliant complaints and Medical Device reports and Correction of related CAPA’s.

Primary focus on Root Cause Analysis and managing the investigations, within Manufacturing floor.

Authored 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.

Chaired Change Review Board. Enforced Change Management process for required CATS Software. Track wise, ALM.

Compliant with GAMP 4 and 5.

Audited Supply Chain process 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.

Focus on CMMS Software for Work Order Mgmt, Inventory Control and Complaints.

Responsible for processing new Complaints and reviewing Complaints submitted for Arbitration.

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;

Ensured Compliance of GCP Compliance in Medical Records.

Authored investigation reports, NOEs and EOEs. Strict adherence required to ISO 13485, 21 CFR 820/806 and utilization of checklists.

Project Manager (consultant)

May 2012 – February 2013

Same vendor 3 different locations

Assigned to Johnson And Johnson, Raritan, NJ Project Manager

Single Point of Contact (SPOC) for IQ/OQ Infrastructure Simplification Project.

Main focus was Oracle and SQL Server IQ/OQ, other Technology areas under review.

Simplified Templates, Test Cases and overall testing, submission and approval processes.

GxP Compliance. Compliant with GAMP-5 (COTS) Utilized SharePoint.

Infrastructure required. Completed, MS Project Server.

Assigned as Project Manager – Chicago, IL, Consultant

Prepared Assessment on the feasibility of establishing 3 2013 Medicare Part D Claims.

Processing Centers with Off Shore and On Site RX processing models.

Utilized SharePoint and MS Project Server.

Provided guidance in the development of the Center of Excellence.

Assigned to Cigna as Project Delivery Manager – Chattanooga, TN Assigned to Proclaim Project

Managed all Testing activities and staff assigned to the Project. Included 3 production releases.

Generated Change Management documents for enhancements.

Data Migration of legacy information for retired files.

Utilized Quality Center 10.0, Epic EMR, SharePoint and MS Project Server.

Managed various Vendors.

Managed assessment and Implementation Plan for ICD-10 implementation.

Focus of Project was on financial applications relating to consolidation for year-end reporting for claims and reserves.

JD Edwards Finance Modules

Clinical Trial Manager (Beta Test) (consultant)

January 2012 – April 2012

DAVITA

Brentwood, TN

Responsible for all Clinical Trial Software, Data Repositories and Reports.

CTMS – design, testing and implementation PM in 3 beta sites.

Audited output from Clinical electronic data collection and provided assessment.

New Dialysis Treatment System – Product Management responsibility for the Clinical 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.

Performed Clinical 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 dispensing and utilization.

Ensured Compliance with GXP primarily GCP for this CRO.

Requirements and functional business specifications authored for test script development.

Utilized SAP, Track wise, SharePoint, QC 10.0, ISO 13485, TS 16949 and Agile SDLC. Completed.

Sr. QA Specialist (consultant)

April 2011 – December 2011

State of Michigan

Lansing, MI

Quality Center 10.0 and 11.0 Subcontractor for Hewlett Packard.

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 Analysis Document.

Authored 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.

Attended Training on following IEEE Modules.

Utilized the IEEE Standards 730, 1012, 1059, 1028, 1044, 1061. Compliance and training on CMMI 3, Implemented Process Improvement Process for Defect processing and resolution.

Sr. Testing Manager (consultant)

July 2010 – April 2011

BCBS of Louisiana

Baton Rouge, LA

Authored HIPAA 5010 Strategy and Test Management Plan for EDI Eligibility Transactions 270/271 and 820, 834,835/837 I, P, D.

Subject to HL7 data standards. Authored and Managed Project Plan and Project Schedule.

Focus on test method validation “psv”

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 Authored 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.

ITS documentation for claims processing. Addressed Trading Partners and Clearing House issues.

Authored on boarding training program for off-shore resources.

Authored and managed to the risk based Testing Work Breakdown Structure.

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.

Sr. Test Manager/PM (consultant) Same vendor 2 different Locations

March 2007 – June 2008

Assigned to Glaxo smith Kline Project Manager Teradata Testing Assessment Raleigh NC

Managed 5 offshore resources and 3 onsite resources.

Required extensive interaction with Vendor regarding Compliance and Software utilization.

Completed analysis of the Teradata Warehouse which replaced Oracle warehouse.

Assessment identified the cost, strategy, resources count for designing test cases and entry of test cases and requirements into HP Quality Center.

Authored and managed to the Testing Work Breakdown Structure.

Tested assessment for GXP Compliance, specifically 21 CFR Part 11 and 820.

Recommendations were included for CSV. Utilized Track Wise. And SharePoint.

Provided hands on Validation of the data migrated to the warehouse.

Ensured Compliance with 21 CFR Part11.GMP, SAP, and CMMI 3.

Assigned to Care First Blue Cross/ Blue Shield, Sr. Test Manager –Consultant Owings Mills, MD

Offshore Team Conversion Project.

Data Migration of previous facets data to new version of facets.

Managed Citrix/Windows installation for Offshore and Onshore.

Testing discipline included MMIS Medicare enrollment, Claims and Billing.

Managed offshore resources, preparation of daily statistical reports, and weekly project reporting to Senior Management. Peer reviewed HIPAA test cases and test results for HIPAA electronic exchange information and code sets. These test cases were executed off-shore.

Managed a Healthcare Testing Team of 15 Off Shore Resources in Hyderabad, India.

Ensured all access and connectivity was available for test case execution.

Authored and managed to the Work Breakdown Structure.

Established preparation of Daily Work Plans (work distribution).

Reviewed of all test cases developed and executed offshore. Responsible for Program Risk Management Plan. Required extensive interaction with Facets and HP Vendors.

Served as an onsite liaison, to Care First, for questions and all required research.

Subject to HL7 data standards and conducted training for my team.

Focus on 4010 EDI Transactions 820, 834, 835 and 837 I, P and D. Reviewed Batch Records for Quality Control. Worked closely with client resource in the Configuration of Dental Codes and Dental Provider file. Audit of EDC records. Applied KPI (Key Performance Indicators) to tester’s performance.

Assessed, restructured, revised and implemented the UAT Testing process.

Actual Hands on Manual Testing of Facets performed to support the Test Team.

Defect Review Board Chairman for the complete Care First Facets Program.

Assessment of the Change Management and implemented new process

Maintained the Quality Management and Change Management Plans.

Extensive daily and monthly statistical reporting.

Utilized Facets, Mercury Quality Center, Oracle and QTP, FitNessee, Cucumber and Test Harness. SOA, .Net Web Testing utilizing Java, Open Source Net.

Validation Lead/CAPA Engineer (consultant)

January 2007 – May 2008

Same vendor 3 different locations

Assigned to Medtronic –CAPA Validation Lead Engineer Clinical Applications, Consultant Minneapolis MN

CTMS implementation of new System in 2 beta sites.

Acted as PM and trained users, prepared daily progress reports and authored Clinical SOPs.

Ensured GCP Compliance for Clinical Sites, performed on site audits on 2 sites.

Applied 21 CFR Part 11 and 820, GXP, ICH and GAMP Compliance principals.

Deviation investigation/document preparation for various stents.

And SAP MM (Materials Mgmt.) Module for Purchase Order and BOM access and review.

SAP QM/PP/MM and Documentum.

Interfaced with SAP PP. Specific Standards were ES 60601-1, ISO 14971, ISO 13485.

Documentation modification for GDP focusing on the product storage, handling and transportation as existing documents was very weak.

Authored and provided training for GAMP training materials.

Audited use of Documentum.

Developed requirements and screen design for schedule planning and adherence, data entry of trial intake and results based on the Protocols.

Participating member of Drug Safety and Surveillance Task Force.

Trained users on the new application and coordinated and participated in UAT.

Contact person for electronic Drug Log and Research Technology Center (Animal

Research) applications. New Development

Waterfall Methodology, GAMP, GLP, GMP. Compliance with CMMI 3.

Prepared Business Requirements for Clinical Research.

Authored IQ, OQ and PQ documentation based on Requirements I developed.

Executed IQ’s and OQ’s for Cardiac stents (i.e. packaging).

Authored Complaint Checklist for Complaint Staff to follow.

Trained Complaint Staff.

Assigned to Boston Scientific - Sr. Product Safety/CAPA Engineer Maple Grove MN

Performed audits on four (4) Clinical Study sites. Participated in the development of Clinical Protocols. Focus was adherence and Compliance to GCP.

Served as interim Clinical Trial Manager.

Validated /Audited new medication tracking software.

Very heavy utilization of CMMS (Blue Mountain) in the manufacturing end. Developed PQ’s for software Computer System Validation.

Risk identification and mitigation strategies for stents and pacemakers.

Follow-up required to determine if mitigation strategies were effective.

Dedicated resource for the creation of business requirements, compensation plans and core lab documentation for Cardiac Research Clinical and Pre-Clinical Studies.

Knowledge of FDA 21 CFR Part 11, 2XX, ICH Regulatory and Compliance rules required. For CSV.

Liaison activities among Vendors (Ven Medical Research), Clinical Sites and information.

Utilized ISO 14971 for Risk Analysis Assessment related to hazardous situations

Monitored the devices during testing, production and post-production.

Utilized the Model Office process for prototyping simulation.

Developed requirements and screen design for schedule planning, adherence, data entry

Audited use of Documentum

Participating member of Drug Safety and Surveillance Task Force.

Trained users on the new applications and coordinated and participated in UAT.

Utilized Waterfall Methodology, GAMP4, GLP, GMP. GCP

Prepared Business Requirements for Clinical Research.

Authored/Executed IQ. OQ and PQ documentation based on Requirements for Cardiac stents (i.e. packaging) for CSV Compliance. Conducted FMEA Analysis on stents.

Planned and managed a major Data Conversion for new Drug Log.

Managed multiple Vendors resources.

Management required for applications.

Participated in the preparation of Regulatory 510’s (PMA) for stents.

Developed Internal Audit Plan for Research Technology Center.

Track Wise and MS Access. Application of ISO 9001, 14971, 17025, 13485, Documentum.

Assigned to Vital Images - Sr. Validation Engineer, Consultant Minneapolis MN

Audited three (3) Hospital sites utilizing CAT Scan Software (Virtuoso).

Authored extensive Test Cases for X-Ray and CAT Scan Software.

Managed Test Plan and Test Case updates with new releases for Software Validation in United States and Japan

Required knowledge - GXP, HIPAA, FDA 21 CFR 820/806 and ICH Compliance and Regulatory

Configured and audited use of SOAPUI Test Tool and Track Wise, Clear Case, SharePoint, Quality Center 9.0.

Managed off shore team in Japan.

Developed templates for COE. ISO 13485, TS 16949 and EU Standards

Sr. SOX Auditor (consultant)

June 2004 – November 2006

Allianz Life

Minneapolis, MN

Evaluated the Health Underwriting and the electronic processes for the application workflow.

Assessed the controls and risks defined under Sarbanes-Oxley compliance in relationship to the systems and audit trails. Regulatory compliance with HIPAA Regulations required.

Utilized Requisite Pro, Clear Case and Clear Quest. Utilized MS Access.

Tested the Physical Security, Security Administration and Financial Systems Interface to determine compliance with Sarbanes-Oxley.

System Interface was very complex as it involved all of the financial reporting Systems. Tool MS Access.

Considerable contact with the stakeholders, financial and IT subject matter experts.

Review and modification of Risks and Controls, development of testing recording spreadsheets, executing tests and preparing Test Summary Reports with Track Wise.

Sr. Computer Validation Specialist (consultant)

June 2001 – May 2004

Schering-Plough Healthcare Products

Memphis, TN

Functioned as Computer Validation Specialist for Legacy Systems.

21 CFR Part 11 Remediation.

Developed Gap Analysis’, developed Remediation Plan’s, managed procedural and technical remediation, Authored Standard Operating Procedures (SOPs), Authored protocols and test scripts, developed IQ/OQ/PQ documents, developed Test Summary Reports, and developed Validation Summary Reports. Performed IQ, OQ and PQ on osmosis Water System.

Managed all compliance corrective documents through the Schering-Plough approval process. All tasks were prepared in accordance with Schering-Plough’s interpretation of 21 CFR Part 11, ICH, Schering – Plough’s World Quality Standards and GAMP-4.

Performed assessment of 5 sites Change Management processes.

Author of new Change Management Process for 5 sites.

Participating member of Drug Safety and Surveillance Task Force.

Performed Validation on the Waters Empower System: IQ, OQ and PQ. Utilized ISO 13485, 14971, TS 16949. Track wise.

Extensive work in the Manufacturing environment.

Implementation OF OSHA Standards as result of 483’s Observations.

Assigned to Johnson & Johnson – Raritan, NJ QA Testing Manager/ Project Manager – Portal Project. Storyboarding and Prototyping utilized for Agile SDLC.

Project had senior management focus on this international delivered project so it was required to manage the budget closely and meet target dates.

Interfaced with Documentum for Crawls and the overall Project.

Received training on Convera and Epicentric software and personally developed validation test scripts for this software. Extensive knowledge of Infrastructure required.

Authored a 700-page User Guide for the I-Portal System. Leveraging of resources critical on this long term complex project.

Resource management and allocation of 10 QA/Testing Analysts.

EDUCATION

BA Psychology Harding University,

Six Sigma Green Belt, Illinois Institute of Technology

Current Certified Associate Project Management (CAPM) program Boston University, 1

Contact this candidate