SUMMARY:

• 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.

TECHNICAL SKILLS:

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 GAMP, GxP, SOPs, SLA s, SOW s, Test Plans, QA Plans, IQ/OQ/PQ, Confidential 21 CFR Part 11 and Annex 11, 50, 54, 56, 312, 314, 510, 812, 814 Compliance, 806, 820, Regulatory PMA 510, LIMS, Confidential 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

Environment: 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

PROFESSIONAL EXPERIENCE:

Validation Expert/PM

Confidential, Swift water, PA

Responsibilities:

• 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. Managed SharePoint dedicate site.
• 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

Confidential, PA

Responsibilities:

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

Confidential, Waltham, MA

Responsibilities:

• 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.
• Performed Data Integrity assessments on documentation ALCOA Compliance.
• 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)

Confidential, Warsaw, IN

Responsibilities:

• Class II and III Devices
• Extensive Batch Record Review for Compliance
• Revised formatting of Packaging Label to conform with Regulations. Approved all Artwork.
• Review and preparation of all 175 CAPA’s relative to received 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 SOPs and data files was monitored and corrections performed as required .
• Interaction with CAPA teams for the completion of Supporting Documentation, 5 Why’s. Use of Minitab for statistical calculation,
• 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, use of GD&T for Manufacturing equipment, Argus Safety
• 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)

Confidential, Cambridge, MA

Responsibilities:

• 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 Confidential 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)

Confidential, Boston, MA

Responsibilities:

• 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)

Confidential, West Chester, PA

Responsibilities:

• 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.
• Handled Complaints for initial review for urgency and relationship to existing CAPAs.
• Reviewed and modified Complaint Documentation prior to release.
• Recommended and implemented Process Improvement Processes. CATS Software.
• Extensive Batch Record Review for Compliance per Confidential
• 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. Utilized GD&T for Manufacturing equipment and Minitab for statistical analysis.
• 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 Confidential Compliance.
• Authored investigation reports, Confidential and Confidential . Strict adherence required to ISO 13485,21 CFR 820/806 and utilization of checklists.

Clinical Trial Manager

Confidential, Brentwood, TN

Responsibilities:

• 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.
• 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)

Confidential, Lansing, MI

Responsibilities:

• Quality Center 10.0 and 11.0 Subcontractor for Confidential .
• 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

Confidential, Baton Rouge, LA

Responsibilities:

• 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 ( Confidential )
• 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 - 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.