Donna Churchill

Associate Director of Quality, CMC at BlazeBioscience

Donna Churchill has worked in the Quality Assurance field since 1989. Donna began their career as a Principal Chemist at Lancaster Laboratories, where they monitored data and analytical compliance with cGMPs, client and agency requirements, and reviewed Batch Records and final testing disposition. In 2007, they moved to SAFC Biosciences as a Quality Operations Supervisor, where they managed multi-shift QA Finished Product personnel and participated in internal/external audits as well as client and regulatory audits. In 2012, they worked as a Quality Assurance Specialist at McNeil Consumer Healthcare as a contractor as part of the site remediation project. In 2013, they joined Covance as a Site Quality Assurance, GLP/GCP North America, where they performed protocol, report, and in-lab phase inspections for compliance to SOPs, protocol and regulatory requirements. In 2018, they became a QA Product Manager at Catalent Pharma Solutions, where they were the primary quality liaison for clients for their product development and clinical supplies. In 2021, they took on the role of Associate Director of Quality, CMC at Blaze Bioscience, where they participate as the Quality SME on cross-functional teams developing process control strategies and performing risk assessments.

Donna Churchill has an educational background in Zoology and Food Science. Donna obtained a Zoology degree from the University of Massachusetts Amherst between 1979 and 1983 and a Food Science degree from Framingham State University between 1983 and 1985. Donna has also obtained several certifications, including a Pharmaceutical Method Validation Training Program from Pharma Webinars in May 2022, a Certified Pharmaceutical GMP Professional (CPGP) from ASQ - World Headquarters in February 2018, and a Certificate of Essentials of Consumer Health Products from CHP Canada in October 2016. Additionally, they have obtained certifications from LinkedIn in 2021, including Be a Better Manager by Motivating Your Team, Become a Six Sigma Yellow Belt, Critical Thinking for Better Judgment and Decision-Making, Operational Excellence Foundations, Quality Management Foundations, Technical Writing: Quick Start Guides, and Time Management: Working from Home.

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Timeline

  • Associate Director of Quality, CMC

    August, 2021 - present

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