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christi shaw

Quality control analyst

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Milwaukee, WI, United States
Pharmaceuticals
Joined April 21, 2023
About
8+ Years of experience in quality control and quality assurance of regulated environments in large molecule (vaccine manufacturing) and small molecule (OTC contraceptives and prescription generic drugs, liquid and solid formulations) pharmaceutical manufacturing. Hands-on experience in laboratory techniques and instrumentation (HPLC, UPLC, UV-vis, etc.), method development and validation, QMS implementation, document control, documentation management according to USP, FDA, ICH guidelines and regulations, writing, reviewing, updating SOPs, project management, supplier qualification, and internal and external audits, FDA inspections, and regulatory calls.
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