Dawn Nestola

About Dawn Nestola

Director of Sterility Assurance & Microbiological Quality for GSKMy background:Accomplished global leader with diverse technical experience and strong interpersonal skills. Twenty + years of experience focused on infection prevention through microbiological quality and sterility assurance in the development and manufacture of medical devices, aseptically-produced pharmaceutical, biotechnology, and consumer healthcare products. Technical competencies include: Aseptic Processing Manufacturing Microbiological Process Controls Ethylene Oxide Sterilization Medical Device Reprocessing

Experience

1. Director of Sterility Assurance and Microbiological Quality

   GSK

   Nov 2022 — Present · Philadelphia, PA, US

Education

• Michigan State University

  Bachelor of Science (BS), Microbiology

  1999 — 2000

• Centenary University

  Master of Business Administration (MBA)

  2006 — 2007

• Jackson College

  Associate of Science (AS), Biological Sciences

  1997 — 1998

Skills

• Validation
• Environmental Monitoring
• Microbiology
• Residuals
• U.s. Title 21 Cfr Part 11 Regulation
• U.s. Food and Drug Administration (Fda)
• Complaint Investigations
• Pharmaceutical Industry
• Sop
• Fda
• Sterilization
• 21 Cfr Part 11
• Standard Operating Procedure (Sop)
• Report Writing
• Bioburden
• Standards Compliance
• Corrective and Preventive Action (Capa)
• Change Control
• Product Development
• Quality System
• Regulatory Compliance
• Laboratory
• Investigative Reporting
• Cell Culture
• Sterility Assurance
• Aseptic Processing
• Process Validation
• Fda Gmp
• Quality Assurance
• Gmp
• Cross-Functional Team Leadership
• Biotechnology
• Product Complaints
• Tuv
• Medical Devices
• Capa
• Technology Transfer