Experience

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  Illumina

  • Software Quality Assurance

    • Provide Regulatory Compliance / Quality Assurance to ensure Illumina’s computer system validation deliverables software and processes for Medical Devices are thorough, complete and developed in a manner consistent with Illumina’s and in a manner acceptable to various health authorities.• Review and approve documents for computer system and process validation and Change Control projects related to Drug Safety Electronic Computer systems for Medical Devices

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  Gilead Sciences

  • Foster City, CA

  • Sr Validation Engineer Regulatory Compliance, Electronic Systems

    • Oct 2015 - Present
    • Foster City, CA

    • Responsible for Review and Approval of all documentation related to Argus Suite Computer System Validation documentation and deliverables for Roche Global, both pre and post execution.• Responsible for Review / Approval of all Change Control and CAPA activities related to Argus Suite and associated programs • Advise and comment creation of documentation required for validation and qualification of all projects related to Drug Safety and Pharmacovigilance

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  Genentech

  • South San Frncisco, CA

  • Sr Validation Analyst

    • Nov 2013 - Oct 2015
    • South San Frncisco, CA

    • Responsible for Review and Approval of all documentation related to ARISg Suite Computer System Validation documentation and deliverables for Roche Global.• Responsible for Review / Approval of all Change Control activities related to ARIS Suite upgrades• Primary project contacts and work groups located in Europe

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  Gilead Sciences

  • Sr Validation Engineer

    • 2013 - 2014

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  Onyx Pharmaceuticals

  • Sr Validation Engineer

    • May 2013 - Nov 2013

    • Project lead for evaluation, installation, validation and implementation of CTMS system, Electronic Lab Notebook (ELN), and upgrades of ARISg and Livelink. • Responsible for Change Control process for various projects.• Authored relevant SDLC documents for validation of system (Validation Plan, Requirements documents, IQ, OQ, PQ, UAT scripts and review and approval of same).• Resolved testing deviations, responsible for CAPA, performed Risk and Gap analysis.• Reviewed and performed Gap analysis of all IT department SOPs for compliance with Part 11 and Annex 11, and updated existing or authored new SOPs as necessary.

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  BioMarin

  • Sr. Validation Engineer

    • Jun 2012 - Dec 2012

    • Project lead for evaluation, installation, validation and implementation of various enterprise programs.• Responsible for Change Control process for various projects.• Authored relevant SDLC documents for validation of system (Validation Plan, Requirements documents, IQ, OQ, PQ, UAT scripts and review and approval of same).• Installed, implemented and validated HP ALM (Quality Center and the e-sig module.• Resolved testing deviations, responsible for CAPA, performed Risk and Gap analysis.• Followed 21CFR 820, Part 11 requirements.• Worked with Documentum, SharePoint and Adobe document systems.

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  BioLife Plasma Testing Laboratory

  • Birmingham, Alabama Area

  • Sr Validation Consultant

    • May 2011 - Dec 2011
    • Birmingham, Alabama Area

    Business Analyst / Validation Consultant for SDLC validation of Laboratory / Testing Laboratory instrumentation.Evaluation and validation and inplementation of new Statistical Evaluation software to meet CLIA and Regulatory agency requirements

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  Smiths Medical

  • New Hampshire

  • Sr Consultant / Regulatory Validation

    • Dec 2010 - May 2011
    • New Hampshire

    Wrote / Evaluated requirements for introduction of major modular additions to their Oracle based Customer Service program.Wrote SDLC validation documents and created Trace Matrix for system validation.Conducted QA review/approval of executed scripts

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  Vertex Pharmaceuticals

  • Cambridge MA

  • Sr Consultant / Business Analyst

    • Mar 2010 - Dec 2010
    • Cambridge MA

    Lead in Testing & Transition Group for installation of a new Learning Management System.Lead in Testing & Transition Group for consolidation of a new Data Center and implementation of a Disaster Recovery program.

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  Direct Technology

  • Sr. Validation Consultant/Documentation

    • Dec 2009 - Feb 2010

    Lead in upgrade of LiveLink (Open Text) from v5.1 to v9.3.

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  US Data Management

  • Sr. Business Analyst

    • May 2009 - Dec 2009

    Lead in upgrade of LiveLink (Open Text) from v5.1 to v9.3.Lead in validation of ARISG from v 5.3 to v 6.1. Responsible for documentation of OQ and PQ for upgrade, including dry runs of scripts and facilitating final executing.

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  Pharmaceutical Validation Service

  • Sr. Consultant / President

    • Apr 2008 - Oct 2009

    Provided consulting and technical writing to meet company's requirements for cGLP and ISO certification and 21CFR Part 11 compliance.Designed and initiated implementation of a complete ISO and cGLP compliant documentation system for clinical testing laboratory including implementation of manual document storage and retrieval database. Designed SOP formats and supervised writing of documents.Confidential Pharmaceutical Client

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  Arena Pharmaceuticals

  • Sr. Validation Consultant

    • Sep 2008 - Apr 2009

    Performed complete installation of ARISg 6.1.1 including writing Validation Plan, all requirement documents, Risk Assessment and Gap Analysis, all IQ, OQ and PQ documents, all summary reports, TM and Final Validation Report. Also wrote and executed data migration from CRO files from ARISg 3.5 and ARISg 5.1 into newly installed ARISg 6.1.1.Worked with IT department to configure ARISg 6.1.1 for parameters including, but not limited to workflow, dictionaries, distribution servers, etc.Wrote and/or modified customized Business Object reports as per clients requirements.Updated and/or converted MedDRA dictionaries to current desired version or previous versions as necessary utilizing ARISg capabilities to update an AER to any version of MedDRA desired.Led safety implementation meetings during the course of ARISg implementation.Involved in gap analysis and resolution adhering to software development standards.Gathered configuration requirements involving workflows, data distribution, and study reports. Facilitated data migration from CRO ARIS systems (ARISg versions 3.5 and 5.3) into newly installed ARISg 6.1.1 and conducted data verification / validation. Assisted in developing additional company SOPs and processes required for ARISg Go-Live.

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  Tri-Anim, Inc

  • Senior Consultant

    • Feb 2008 - Aug 2008

    Created and implemented policies, procedures and training program (Quality System) for Medical Device manufacturer to comply with FDA MDR program. Advised on responding to MDR complaints.

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  Watson Pharmaceutical, Inc

  • Senior Consultant

    • May 2008 - Jul 2008

    Authored required SDLC documents including design and requirements specifications, validation, facilitated execution of testing scripts for upgrade of Argus Safety System version 2.9.1 to version 4.2 to enable system Go-Live. Upgraded path from 2.9.1 to 3.x to 4.2. Authored summary reports and facilitated completion of UAT and cross-over validation, wrote final reports.Performed Gap Analysis and Risk Assessment for Computer Quality Systems and IT departments and evaluated SOPs and policies for adherence to relevant GxP/ISO compliance.Responsible for validation of data, field verification, automation, and correcting configuration flaws. Facilitated data migration verification/validation from Argus v 2.9.1 into version 4.2. Migrated 250k case files.Worked with Cognos for ARGUS data. Updated and/or converted WHO/DRL dictionary in ARGUS.Wrote or modified customized Business Object reports as per clients requirements.

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  Watson Pharmaceuticals, Inc

  • Senior Consultant

    • Jan 2008 - Mar 2008

    Reviewed product complaint processes and produced process/procedure improvements. Created and presented training program. Evaluated and validated data migration for Argus Drug Safety Software upgrade from 2.9.1 to 4.2. Assisted in establishing reports using Crystal, Business Objects.Wrote validation plan and SDLC validation documentation (FS, DS, and Trace Matrix).

  • Senior Consultant

    • Aug 2006 - Jan 2008

    Authored and executed SDLC validation activities for corporate computer systems, including all phases of validation documentation for system and software validation. Served as technical consultant for implementation of major enterprise system hardware/software upgrades including Livelink and Trackwise. Authored SOPs, training manuals, and work instructions for corporate and IT departments. Key contributor in Argus configuration and support, as well as implementation of Insight for reporting purposesManaged vendor audit program. Authored Change Control procedures for Corporate Quality Departments. Authored SDLC, RACI and Risk Management procedures. Lead in validations of various network & infrastructure systems and software.

  • Senior Consultant

    • Dec 2005 - Jul 2006

    Created and published SOPs, Validation templates and procedures for QC department and for Global unity.Involved in vendor selection resulting in Argus.Initiated and implemented company transition from manual in-house document repository systems to a newly created EDMS LiveLink system. Facilitated user training in use of new EDMS via virtual and in-class sessions. Facilitated and validated data migration from in-house database and cleansing of migrated files.Created MS Access database programs for tracking, searching and metric evaluation of document library.Authored project plans and proposals for document transition, introduction of new document hierarchy, types and document management for LiveLink. Authored and implemented Style Guide for company global use. Authored and implemented a Global Definition and Acronym database.

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  Propriarity

  • Consultant/Sr. Technical Writer

    • Jun 2005 - Feb 2006

    Provided consulting and technical writing to meet company's requirements for cGLP and ISO certification and 21CFR Part 11 compliance.Designed and initiated implementation of a complete ISO and cGLP compliant documentation system for clinical testing laboratory including implementation of manual document storage and retrieval database. Designed SOP formats and supervised writing of documents.Confidential Pharmaceutical Client

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  Amgen Inc

  • Consultant

    • Sep 2005 - Dec 2005

    Authored and published SOPs, Validation templates and procedures for Regulated Information Systems Quality department for GMP/GLP/GCP global unity. Facilitated efforts of 5 off-site divisions to bring documents into global unity.Authored SOPs for validation of COTS and CRS systems including 21CFR Part 11 requirements. Created and implemented document management and storage system.Created templates for all phases of validation effort for Regulated IS department, including Validation Plan, Requirement/Design Specification, IQ/OQ/PQ, as well as summary reports and testing procedures.Established SDLC and Change Control procedures. Conducted Risk Management evaluation of procedures for Quality department.

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  Bristol-Myers Squibb

  • Sr. Technical Writer

    • Jul 2004 - Jun 2005

    Authored over 200 SOPs and OIs for BioSafety Level-3 facility to ensure proper cGLP. Authored Lockout/Tag out documents for all equipment and systems at facility. Created and implemented manual database (MS Access) for storage and retrieval and searching of company's procedures.Developed Change Control procedures for division. .

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  Pfizer Inc

  • Sr. Technical Writer / Manager and Lead Technical Writer

    • Jan 2003 - Jul 2004

    PTS) Group. Provided technical writing and validations to meet company's quality validation requirements.Authored various validation protocols, product specifications, SOPs, engineering studies. Authored Line Trial and Validation Protocols for sterile and non-sterile validations analyzed data and wrote final reports. Facilitated multi-discipline validation teams.Developed hierarchy and served as administer for Documentum.

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  Pharmaceutical Validation Service (PVS)

  • Consultant/Sr. Technical Writer

    • Jan 2001 - Jan 2003

    Designed, set up and supervised production facility for the manufacture of sterile solutions for use in clean rooms. Lead consultant for sterile packaging operation of new medical device, including all processes from manufacture to distribution of sterile product.Initiated and submitted ANDA, and received FDA approval for production and distribution of medical device. Served as chief contact with government agencies for approval of ANDA.

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  Honeywell Corp

  • Technical Writer

    • Jan 1998 - Jan 2001

    Originated style guide for Technical Writing group. Authored in excess of 100 Process Operation Manuals used for operator training and certification. Authored SOPs and other publications as required. Designed template and authored LO-TO documentation for more than 400 pieces of equipment and power sources. Wrote manuals for use in Europe, Asia, Africa and USA.. Authored and facilitated companywide Six Sigma training program and other training programs.

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  Alfred Elder Enterprises

  • Technical Writer/Consultant

    • Jan 1997 - Jan 2001

    Authored specifications and technical use manuals for newly designed and/or modified pharmaceutical manufacturing equipment, including Instrument Qualification protocols.

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  Alza Pharmaceuticals

  • Project Management / Technical Writing/Consultant

    • Jan 1998 - Jan 1999

    Designed, set up and managed project tracking program for scale-up through production and market introduction of a new pharmaceutical medical device, incorporating all IQs, OQs and PQs required under CFR and FDA guidelines.Designed MS Access database for use in conjunction with MS Project for storage, retrieval and searching of key documents, components and resources of project.Scheduled validations of all manufacturing components, computer programs, and device components, testing criteria for components at each stage of production and final evaluation and testing of the completed device.

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  Bayer Pharmaceuticals

  • Manager, Quality Control

    • Jan 1976 - Jan 1996

    Managed 20-person Quality Control laboratory including personnel, budget, test methods, and interaction with regulatory agencies.Established facility Master Plan, wrote specifications and procedures for evaluation and testing of raw materials, in-process and final container product testing, manufacturing specifications, which included equipment maintenance, set-up, tear-down and cleaning.