Arshia M.
Senior Analyst i @Ultragenyx
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WORK HISTORY
Senior Analyst i @Ultragenyx
Boston, MA, US
Support Ultragenyx\'s gene therapy program including routine GMP testing of AAV vector analytical methods such as, impurity testing, and other methods as needed. Support internal laboratory testing and method development/validation.Perform quality data review for method validation, method reports, QC logbooks, and QC data.Work independently to analyze, review, and trend QC data and generate stability and other trending reports as necessary.Support QC deviations, investigations, change controls, analytical method performance trending and root cause analysis.Operate all laboratory instruments including: pH meter, Balances, Sciex CE-SDS, Waters HPLC, Empower Software, and 32-Karat Software.Electronic review using LIMS (Laboratory Information Management Software) and Veeva QMS (Quality Management System).
EDUCATION
Farmingdale State College
Bachelor of Science - BS, Biology, General
ABOUT ARSHIA M.
QUALITY SYSTEMS SPECIALIST / SENIOR QC / ANALYTICAL SCIENTIST / QUALITY ASSURANCE Detail-oriented quality professional with 7+ years of GMP experience supporting pharmaceutical and gene therapy programs. Strong background in QC data review, deviations, investigations, change control, documentation, and quality systems. Proven ability to work independently, ensure compliance, and support regulated operations in fast-paced environments. Graduate from Farmingdale State College who gained the ability to effectively seek out and process scientific information, including primary sources and genomic databases. Demonstrates mastery of laboratory skills, expertise in the operation of modern instrumentation, adherence to laboratory safety standards, and good practices. Able to process experimentally derived data and to communicate results effectively by written, graphical, digital, and verbal means.
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