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, 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 sitesCompliance 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, Data Integrity

Environment: s: 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, SeleniumMethodologies 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

Responsibilities:

• 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. 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

Responsibilities:

• 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 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

Confidential

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.