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Highly motivated professional with over 15 years of administrative and document control project management experience.  Provides technical writing and quality oversight in support of commissioning, validation, SOP’s, training materials, and protocol development.

  • Established SharePoint cGMP Document Management Server System and SOP to manage the process.

  • Ensured that documentation was complete, recorded, and compliant with cGMP’s regulations.

  • Created and updated Standard Operating Procedures for various departments.  Established an electronic library meeting regulatory guidelines for document storage and retrieval.

  • Responsible for the development of commissioning/ validation protocols (FAT, IOQ, PQ).

  • Maintained, tracked, and provided validation deficiencies list to support remediation.

  • Maintained multi-department action item lists and followed to closure.

  • Responsible for development and training of client staff on the New Equipment.

  • Creation of cGMP controlled forms, scheduling trackers, and step-by-step training documents.

  • Collaborated with Engineering to create Operation & Troubleshooting Guide.

  • Coordinated multi-department off-site meetings.  Worked with department heads in creation of presentation Dashboard and Key Performance Indicators.

  • Establish training schedule of various departments with Original Equipment Manufacturers (OEMs)

  • Management of Site Acceptance Tests, meeting and corresponding with OEMs, documenting results, and tracking action items.

  • Ensured OEMs met all obligations of their contract and equipment performed accordingly prior to final payment

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