SUMMARY

• IT systems professional with extensive systems experience in Confidential, Sales Force Automation, Decision Support, and Data Warehousing, and Project Management.
• Experience authoring Validation documentation to include; User Requirements Specification, Master Validation Plan, OQ Test Plan, PQ Test Plan, OQ/PQ Test Scripts, Traceability Matrix, as well as all validation summary documents.
• Experienced in the validation of the following suite of software: dsNavigator, dsNavigator IAT, Inform and Empirica Trace; for submission of clinical trial data to the Food and Drug Administration and other regulatory authorities.
• Experienced in all phases of systems development and project life cycle methodologies.
• Skilled in creating relationships with users and identifying core business needs for systems that exceed user’s expectations.
• Expertise in validating, trouble - shooting, and testing systems on all platforms.

PROFESSIONAL EXPERIENCE

Confidential

Validation Lead

Responsibilities:

• Provided Confidential expertise to Confidential staff on an on-going basis.
• Responsible for validation of the Electronic Product Experience Report (ePER) application used for reporting product defects/irregularities.
• Responsible for authoring Validation Plan, Requirements Specification / Traceability Matrix, Requirements Testing Protocol and Final Validation Report.
• Responsible for supporting Confidential personnel during Protocol execution.

Confidential, NJ

Validation Lead

Responsibilities:

• Provided Confidential expertise to Confidential staff on an on-going basis.
• Responsible for qualification of PDF Manipulation utility used for regulatory submissions.
• Responsible for authoring Traceability Matrix to trace functional requirements to test scripts.
• Responsible for authoring Installation Qualification and Operational/Performance Qualification test scripts in HP Quality Center 10.0.
• Responsible for dry-running Installation Qualification and Operational/Performance Qualification test scripts in HP Quality Center 10.0.
• Responsible for final execution of Installation Qualification and Operational/Performance Qualification test scripts in HP Quality Center 10.0.
• Provided feedback and guidance on format and content of Qualification Summary Report.
• Provided trouble-shooting support for various bugs found during dry-runs.

Confidential, FL

Validation Lead

Responsibilities:

• Provided Confidential expertise to Confidential staff on an on-going basis.
• Responsible for full lifecycle validation of NextDocs v6.1 for SharePoint 2010, as well as providing assistance with creation and revisions of TrackWise SelectStart v8.5 and ProCal Calibration Management System v5.7 validation documentation.
• Responsible for authoring NextDocs System Requirements Specification, GAMP-5 Risk Assessment and Traceability Matrix.
• Responsible for dry-running NextDocs Operational/Performance Qualification test scripts and confirming client configuration.
• Responsible for authoring NextDocs Operational/Performance Qualification Protocol.
• Assisted with creation of client SOPs.
• Provided support during Operational/Performance Qualification execution.
• Responsible for authoring Production Installation Qualification Summary Report, Operational/Performance Qualification Summary Report and Validation Summary Report.
• Responsible for the interpretation of 21 CFR Part 11 regulations and the adherence to these regulations.

Confidential, MA

Senior Validation Specialist

Responsibilities:

• Provided Confidential expertise to Confidential staff on an on-going basis.
• Responsible for full lifecycle validation of SAS 9.3, including BASE SAS, SAS/ACCESS, SAS/STAT, SAS/GRAPH and SAS/IML, as well as validation documentation review of Oracle Clinical 4.6, Remote Data Capture 4.6 and Thesaurus Management System 4.6.1 upgrades.
• Conducted analysis on upgrades and fixes between versions SAS 9.1 and SAS 9.3 in order to gain a comprehensive understanding of the regulatory implications, including 21 CFR Part 11.
• Responsible for authoring, tracking and reporting on the validation project plan.
• Responsible for reviewing client authored Validation Plan and Installation/Operational Qualification Protocols.
• Responsible for authoring Performance Qualification Protocol and Validation Summary Report.
• Created SAS/IML programs to test version 9.1 Correlation and version 9.3 Regression.
• Conducted final execution of SAS 9.3 PQ Protocol and confirmed results.
• Responsible for the interpretation of 21 CFR Part 11 regulations and the adherence to these regulations.
• Facilitated weekly meetings with the BioMetrics, IT, and Quality Assurance departments to review progress and potential issues during the validation process.
• Provided Confidential expertise to Aegerion Pharmaceutical staff on an on-going basis.
• Responsible for full lifecycle validation of NextDocs Regulatory and Quality (SOP) modules for the repository and submission of regulatory documents/filings to the Food and Drug Administration and other regulatory authorities.
• Conducted analysis on each software package in order to gain a comprehensive understanding of functionality, how it is used in the submission of clinical data, and regulatory implications.
• Responsible for producing all validation documentation, including; User Requirements Specification, Master Validation Plan, OQ Test Plan, PQ Test Plan, OQ/PQ Test Scripts, Traceability Matrix, as well as all validation summary documents.
• Responsible for the quality review of written test scripts, execution of test scripts, and post-execution results.
• Responsible for the interpretation of 21 CFR Part 11 regulations and the adherence to these regulations.
• Facilitated weekly meetings with the IT department, testers (users), and system owners to review progress and potential issues during the validation process.

Confidential, WA

Responsibilities:

• Provided Confidential expertise to Confidential staff on an on-going basis.
• Responsible for validation of the following suite of software: dsNavigator, dsNavigator IAT, Inform and Empirica Trace; for submission of clinical trial data to the Food and Drug Administration and other regulatory authorities.
• Responsible for full lifecycle validation of NextDocs Regulatory and Quality (SOP) modules for the repository and submission of regulatory documents/filings to the Food and Drug Administration and other regulatory authorities.
• Conducted analysis on each software package in order to gain a comprehensive understanding of functionality, how it is used in the submission of clinical data, and regulatory implications.
• Responsible for producing all validation documentation, including; User Requirements Specification, Master Validation Plan, OQ Test Plan, PQ Test Plan, OQ/PQ Test Scripts, Traceability Matrix, as well as all validation summary documents.
• Responsible for the quality review of written test scripts, execution of test scripts, and post-execution results.
• Responsible for the interpretation of 21 CFR Part 11 regulations and the adherence to these regulations.
• Conducted meetings with the IT department, testers (users), and system owners to review progress and potential issues during the validation process.

Confidential, MA

Senior CSV Specialist

Responsibilities:

• Responsible for validation of the following suite of software: dsNavigator, dsNavigator IAT, Inform and Empirica Trace; for submission of clinical trial data to the Food and Drug Administration and other regulatory authorities.
• Conducted analysis on each software package in order to gain a comprehensive understanding of functionality, how it is used in the submission of clinical data, and regulatory implications.
• Responsible for producing all validation documentation, including; User Requirements Specification, Master Validation Plan, Operational Qualification Test Plan, Performance Qualification Test Plan and OQ/PQ Test Scripts, as well as all validation summary documents.
• Provided Confidential expertise to Confidential staff on an on-going basis.
• Responsible for teams of testers from several disciplines within the Confidential organization.
• Responsible for the quality review of written test scripts, execution of test scripts, and post-execution results.
• Responsible for the interpretation of 21 CFR Part 11 regulations and the adherence to these regulations.
• Conducted meetings with the IT department, testers (users), and system owners to review progress and potential issues during the validation process.

Confidential, FL

Quality Assurance Analyst

Responsibilities:

• Responsible for the on-going quality assurance of the Florida Safe Families Network application; assuring the testing and validation of Maintenance builds, managing and conducting User Acceptance Testing, managing requirements / testing traceability matrix, and assure quality of Release 2/3 design.
• Conducted testing of monthly Maintenance builds (bug fixes and change requests), ensuring the stability and validation of each build before going to production, as well as managing and conducting User Acceptance Testing of Release 1.
• Supported the Statewide Abuse Call Center and Helpdesk for several weeks during go-live post-implementation to ensure the application is adequately supported.
• Participated in Release 2/3 design sessions with responsibility for quality assurance oversight to ensure all functional requirements are met, and quality is considered with every design decision.
• Developed full-functionality Release 2/3 User Acceptance Test scripts based on design decisions to ensure all functional requirements are designed for and tested thoroughly.

Confidential

Senior CSV Specialist

Responsibilities:

• Responsible for the retrospective validation of 25 Excel Workbooks used in the Genomics, Hematology, Microbiology, Automated Chemistry, and Special Chemistry departments for submission of clinical trial data to the Food and Drug Administration and other regulatory authorities.
• Conducted analysis on each Excel Workbook in order to gain a comprehensive understanding of functionality, how it is used in the submission of clinical data, and regulatory implications.
• Responsible for the authoring of Spreadsheet Validation Test Plans for each Excel Workbook. Test plans included comprehensive testing of ranges, invalid values, conditional formatting, table lookups, and calculations and formulas.
• Conducted reviews of the test plans with the Covance Quality Assurance department liaison to ensure all internal and 21 CRF Part 11 requirements are being met.
• Conducted meetings with the IT department and the users together to suggest process improvements in the laboratory and technical improvements to the workbooks.

Confidential, MA

Senior CSV Specialist

Responsibilities:

• Conducted analysis on each software package in order to gain a comprehensive understanding of functionality, how it is used in the submission of clinical data, and regulatory implications.
• Provided Confidential expertise to Confidential staff on an on-going basis.
• Responsible for team of 15 testers from several disciplines within the Confidential organization.
• Responsible for the quality review of written test scripts, execution of test scripts, and post-execution results.
• Responsible for the interpretation of 21 CFR Part 11 regulations and the adherence to these regulations.
• Assisted in authoring test plans, test scripts, and post-execution summary reports to ensure a consistent validation process.
• Conducted meetings with the IT department, testers (users), and system owners to review progress and potential issues during the validation process.

Confidential, FL

Systems Validation Consultant

Responsibilities:

• Developed validation protocols for final user acceptance testing after thorough analysis and understanding of user requirements.
• Executed validation protocols and test scripts for system level testing.
• Developed validation protocol for regression testing strategy to ensure stability of system in future releases.

Confidential, NJ

IT Systems Consultant

Responsibilities:

• Developed 18-month project plan including tasks, as well as tracking deliverables and milestones.
• Developed test plans for installation of multi-tiered hardware and software infrastructure.
• Utilized Crystal SDM and Lotus Notes TeamSpace to ensure delivery of appropriate system and validation documents, and timely review of critical system deliverables.
• Assisted in developing User Requirements Specifications, Functional Specifications, and Detail Design Specifications based on analysis of clinical source systems, 21 CFR Part 11 compliance requirements, and Confidential requirements.
• Developed Quality Plan and Quality Report based on software and hardware testing requirements and testing results.
• Reviewed and approved Unit, Integration, Installation, Operational, and Performance Test Specifications based on thorough understanding of infrastructure and data mart requirements.
• Participated in numerous Confidential classes, including Computer Validation for IT Developers, Train the Trainer, GCP, GLP, GMP, and 21 CFR Part 11.

Confidential

Responsibilities:

• Developed 12-month project plan including tasks, as well as tracking deliverables and milestones.
• Conducted daily status meetings to ensure adherence to the deliverable schedule.
• Utilized Crystal SDM and Lotus Notes TeamSpace to ensure delivery of appropriate system and validation documents, and timely review of critical system deliverables.
• Developed Project Mandate and Statement of Work documents based on 21 CFR Part 11 compliance requirements.
• Developed User Requirements Specifications, Functional Specifications, and Detail Design Specifications based on three-month analysis of Sample Accountability applications.
• Developed Validation Protocol and Acceptance Criteria based on analysis of high and medium risk functionality.
• Wrote Validation Test Scripts based on thorough understanding of IQ, OQ, and PQ requirements.
• Successfully passed Part 11 Compliance Audit.

Confidential

Project Leader

Responsibilities:

• Developed 12-month project plan including tasks, resource allocation, as well as tracking deliverables and milestones.
• Tracked actuals for 14 project team members and presented weekly progress statistics.
• Utilized Crystal SDM and Lotus Notes TeamSpace to ensure delivery of appropriate system and validation documents, and timely review of critical system deliverables.
• Conducted weekly status meetings with project team members to resolve issues and stay on schedule.
• Developed program specifications for critical batch processes.
• Successfully passed FDA Part 11 Compliance Audit.
• Project Team received Novartis Business Partnership Award.
• Managed entire project life cycle for Yr. 2000 compliance of a dozen Marketing Strategic Business systems. Also conducted eight weeks of analysis to determine the Yr. 2000 compliance of PC hardware for over 600 external customers. Platform includes UNIX, Oracle, and Windows NT environment.
• Developed six-month project plan including resource allocation, as well as tracking milestones and deliverables.
• Developed strategy and implemented process for verification of compliance results in order to ensure functional stability of system, thereby raising comfort levels.
• Conducted status meetings with project team members to resolve issues and stay on schedule.
• Wrote and implemented an ongoing compliance plan to ensure continual Y2K compliance into the 21st century.
• Wrote and implemented contingency plans for alternative Y2K solutions.