Michael Newton

Sr Director, Qa Qc (Site Head of Quality) @Discgenics

Farmington, UT, US
EMAILS
m••••••••@discgenics.com
MOBILE NUMBERS
+18•••••••76

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WORK HISTORY

Nov 2021 — Present

Sr Director, Qa Qc (Site Head of Quality) @Discgenics

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Responsible for Quality Management Systems, Validation, Metrics, and Compliance related to a clinical stage biopharmaceutical company developing regenerative cell-based therapies. Management of all quality related activities including, but not limited to, Quality Assurance, Quality Control, Microbiology, Document Control, Quality Engineering, Supplier Qualification, and Compliance. Implementation and management of quality processes related to sterile pharmaceutical manufacturing and cell…

EDUCATION

2001 — 2005

University of Utah

Bachelor's degree, Chemistry

2005 — 2007

University of Utah

Master of Science (M.S.), Chemistry

SKILLS

EmpowerGlpMhraFdaTrackwiseAnalytical ChemistryLivelinkEquipment QualificationHplcLimsOperational ExcellenceAnvisaComplaint InvestigationsTransdermalProduct ComplaintsDissolutionDeviationsJob SchedulingSopPharmaceutical IndustryEmaGxpHands-on TrainingV&VIrCapaQuality Control21 Cfr Part 11GmpValidation

ABOUT MICHAEL NEWTON

I have over 20 years of experience working in challenging environments including the…

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