Urlene Glassman
@urleneglassman
I strengthen GMP quality systems, stability programs, and regulatory compliance.
United StatesWhat I'm looking for
At Natera, I manage GMP documentation, quality events, CAPAs, supplier oversight, and inspection-ready records across medical device operations regulated by CLIA, FDA, QSR, ISO 13485, GMP, GLP, ICH, and HIPAA.
I previously led stability programs at Mile High Labs, managing study design, execution, data review, reporting, and compliant controlled documentation for nutraceutical and pharmaceutical products. At Agilent Technologies, I performed cGMP analytical testing for APIs, finished oligonucleotide drug products, raw materials, and stability samples in CMO and CDMO manufacturing environments.
I use PowerBI, Jira, and MasterControl to analyze trends, support quality decisions, strengthen workflows, and drive corrective actions.
Experience
Work history, roles, and key accomplishments
Ensure compliance with CLIA, FDA, QSR, ISO 13485, GMP, GLP, ICH, and HIPAA across medical device operations. Manage GMP documentation control, lead quality event management, and conduct root cause analysis.
Education
Degrees, certifications, and relevant coursework
Fort Hays State University
Bachelor of Science, Chemistry
Bachelor of Science in Chemistry from Fort Hays State University.
Availability
Location
United StatesAuthorized to work in
Job categories
Skills
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