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Dylan RubyDR
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Dylan Ruby

@dylanruby

I investigate quality issues and strengthen compliance for FDA-regulated diagnostics and biopharmaceutical manufacturing.

United States
Message

I'm currently a Quality Engineer II at Waters, formerly BD Advanced Diagnostics, investigating customer complaints, CAPAs, root causes, and corrective actions for regulated diagnostic products.

I review deviations, change controls, and quality notifications; analyze quality trends; author SOPs; and support FDA and ISO audit readiness. I also partner across teams to resolve operational and compliance issues and drive quality actions to closure.

Previously, at Frederick National Laboratory for Cancer Research, I performed GMP walkthrough audits, reviewed batch records and QC results, released raw materials, supported production clearance, and helped implement the Supplier Evaluation Program.

My background also includes quality control and laboratory work at BD and public health testing at the Maryland Department of Health. I bring a Master of Science in Regulatory Science and Lean Six Sigma Black Belt certification to quality systems, continuous improvement, and regulated laboratory environments.

Experience

Work history, roles, and key accomplishments

MH

Public Health Laboratory Scientist I

Maryland Department of Health

Nov 2020 - Mar 2021 (4 months)

Triaged COVID-19 specimens and verified patient and sample information in a public health laboratory setting. Assigned specimens across testing platforms and tracked sample status in STARLIMS.

Education

Degrees, certifications, and relevant coursework

Johns Hopkins University logoJU

Johns Hopkins University

Master of Science, Regulatory Science

Master of Science in Regulatory Science from Johns Hopkins University.

Ohio University logoOU

Ohio University

Bachelor of Science, Cellular and Molecular Biology

Bachelor of Science in Cellular and Molecular Biology from Ohio University.

Tech stack

Software and tools used professionally

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