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QA Manager Testing Manager Validation

Blakely, Pennsylvania, United States
January 27, 2018

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*** ***** ******, *** **, PECKVILLE, PA 18452

CELL 225-***-****

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.


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, 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.


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

Compliance: Life Sciences & Medical Device: 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

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, TrackWise, FitNessee, Cucumber, Test Harness, Open Source Net Beans, Selenium, Minitab,

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


Validation Expert/PM

June 2016 – December 2016

Sanofi Pasteur

Swift water, PA

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, TrackWise, Galaxy, ProficyCM, iAttend, SAP US - Modules = Product Life Cycle Management, Quality Management, Materials Management, Production Planning, Human Resource Management, Project System, FICO, Process Integration. Payroll

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 TrackWise. Required GXP, 21 CFR Part 11, 210, 211 knowledge.

Managed TrackWise for Complaints, NOE, EOE, and SharePoint

Extensive investigation, auditing and validation skills required.

Validation of numerous SOP(s) and Validation documents for accuracy, including solid dose, vaccines and syringe filing

Packaging SOPs for Sterile Barrier Systems and Protective Packaging Secondary and Tertiary

Validation of documentation with manufacturing facilities.

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

Extensive use of the knowledge of 21 CFR Part 11 and 820, ISO 13485, GxP, cGXP, GAMP 4, GAMP 5, ISO 14971, ISO 13485. ISO 17025, ISO 9001

Utilized several document repositories: GeodIS, GeodIS+, QeDocs, DocuSign, SharePoint

Performed Data Integrity assessments for Lab Systems for documentation ALCOA Compliance.

QA/Testing Manager 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.

Implementation of upgraded IVR System for Call Center. Managed the creation of call center scripts (inbound/outbound) in Spanish and English. Beta tested for 2 months and placed into production. Hands on script writing and testing for Cisco Finess and Nuance IVR applications.

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

Utilized Data Analytic Tools Tableau and Looker

JD Edwards for 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.

Managed CMS MOMS Programs 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. TMV documentation

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

Provided training for Data Integrity documentation compliance

Sr. CSV Engineer/PM (consultant)

April 2015 – June 2015


Waltham, MA

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

Provided assessment and audit for 21 CFR Part 11.

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


Warsaw, IN

Class II and III Devices

Program Manager for CAPAs for FDA Audit, Processed Complaints, DMRs, DHFs.

Extensive Batch Record Review for Compliance

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.

Packaging SOPs for Sterile Barrier Systems and Protective Packaging Secondary and Tertiary

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 TrackWise.

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, ISO 14971, 21 CFR Part 11 and 21 CFR Part 820. TrackWise, SharePoint, DocuSign, Argus Safewty

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

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

Handled Complaints. Initiation through Arbitration. Member of Complaint Arbitration Board.

Utilized TrackWise. Argus Safety for Complaints, Case Studies, Looker,Reports and Dashboard

Testing Manager (consultant)

June 2014 – Sept ember 2014


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.

Supported Users for creation of 156 Requirements.

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

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. Enhanced existing SOPs for Track and Trace Process.

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

Responsible for Test Team resources planned and budget.

Strict enforcement of Data Integrity concepts on test results documentation.

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

Tested PLC Compliance for microcontrollers within Manufacturing.

Maintained and Utilized – TrackWise, SharePoint, myCIMS, DocuSign

QA Test Manager (consultant)

March 2014 – May 2014


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. ISO 14971, ISO 13485. TS 16949

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

Class II and III Devices

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

Performed GAP analysis on the CAPAs prior to audit. Items considered were the relationship to Cli

Recommended and implemented Process Improvement Processes. CATS Software.

Extensive Batch Record Review for Compliance per FDA

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. TrackWise, ALM. Argus Safety for Complaints, Case Studies, Reports and Dashboard

Compliant with GAMP 4 and 5.

Audited Supply Chain process for Manufacturing of 2 Spinal Products, Compliance with GAMP4&5

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 medical records, for complaint information & ensured GCP Compliance.

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

Program/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.

Audited all SOPs for streamlining

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 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. Managed various Vendors.

Generated Change Management documents for enhancements.

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

Enforcement of Data Integrity guidelines in Test Script execution results.

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.

TSV Document, ISO 13485, ISO 14971, TS 16949

Clinical Trial Manager (Beta Test) (consultant)

January 2012 – April 2012


Brentwood, TN

Responsible for all Clinical Trial Software, Data Repositories and Reports for new Dialysis Treatment Software System

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

Audited output from Clinical electronic data collection and provided assessment.

Direct hands-on 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, TrackWise, 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.

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.

Focus on Test Method Validation (TSV)

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

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.

Enforcement of Data Integrity guidelines in Test Script execution results.

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 TrackWise. And SharePoint.

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

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

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

Offshore Team Conversion Project.

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.

Managed a Healthcare Testing Team of 15 On Shore and 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.

Prepared an 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)

Same vendor 3 different locations

Assigned to Medtronic –CAPA Validation Lead Engineer Clinical Applications, Brooklyn Center, MN

Clinical (GCP) and Class II and III Devices

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.

Packaging SOPs for Sterile Barrier Systems and Protective Packaging Secondary and Tertiary

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. Batch record review.

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 4, GLP, GMP. Compliance with CMMI 3.

Authored Business Requirements for Clinical Research, IQ, OQ and PQ documentation

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

Authored Complaint Checklist for Complaint Staff to follow. TRAINING AS REQUIRED

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

Clinical – Class III Devices

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

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

Served as interim Clinical Trial Manager.

Validated /Audited new medication tracking software.

Risk identification and mitigation strategies for stents and pacemakers.

Dedicated resource for the creation of business requirements, compensation plans and

core lab documentation for Cardiac Research Clinical and Pre-Clinical Studies.

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.

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

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.

Managed multiple Vendors resources.

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

Developed Internal Audit Plan for Research Technology Center.

TrackWise and MS Access. CMMS (Blue Mountain). Application of ISO 9001, 14971, 17025, 13485, 21 CFR Part 11, 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 TrackWise, 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) Allianz Life

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. Model Office Tiers 1-3.

Assigned to: Paterson Dental - IT Compliance Specialist (SOX).

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 scripts and preparing Test Summary Reports with TrackWise.

Sr. Computer Validation Specialist Schering Plough (consultant) under Consent Decree

Specialist for 21 CFR Part 11 Remediation. SAP Module PP reconfigured

Streamlined internal processes for handling OTC Drugs and related Customer Service issues

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.

Author of new Change Management Process. Assessment of 5 sites Change Management

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. TrackWise. Primarily with SOPs relating to Track and Trace and syringe filling

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

Testing Manager/ PM Portal Project. (consultant) Johnson & Johnson

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.

Resource management and allocation of 15 QA/Testing Analysts.

Enforcement of Data Integrity guidelines in Test Script execution results.


BA Psychology/History Harding University,

Six Sigma Green Belt, Illinois Institute of Technology

Currently pursuing Certified Associate Project Management (CAPM) program Boston University, received 1/3 scholarship from Boston University


Member American Society for Quality (ASQ),

Certificate in Project Productivity Management; 2007

Certificate in ITIL Foundations; 2007

TRAINING and Practical Hands On Application

Healthcare processes, Reinsurance, Auto Insurance, Whole Life, Term Life and Property/Causality

Class I, II a & b, III Medical Devices

All Pharmaceutical Phases

Extensive FDA Compliance/Regulatory training relative to Pharmaceutical Life Sciences, Medical Device. CATS web, CATS, MyCIMS, SOX, HIPAA

Contact this candidate