Site manager supporting commercial and clinical manufacturing of small molecule drug substances and drug product across multiple contract manufacturers.

Support Process Maturity as process owner of Supplier Management, Quality Agreements, Deviations, and CAPAs.Support implementation of QMS Electronic Solutions.

Provide Quality Assurance oversight of contract manufacturers, including deviation resolution, change management, and batch review and disposition.Support and lead Quality initiatives and drive continuous improvement.Author the Annual Product Quality Review for Portola's first commercial product.

Promote continuous improvement and consistent/open communication related to all Gilead projects at CMO as Quality Functional Site Lead.Represent Quality Assurance for external audits of CMOs.Interface with contract manufacturers to address compliance and/or documentation issues.Review/approve documents related to manufacturing, batch release, validation, deviations, and other GMP-related processes.Disposition commercial active pharmaceutical ingredients and drug product intermediates for use in final drug product.Author annual product reviews for commercial API.Lead trainer for internally-developed quality systems application.

Reviewed/approved Validation Plans, IQ/OQ/PQ, Trace Matrices, Test Scripts, Validation Summary Reports to ensure compliance with 21 CFR Part 11 and company policies.Assessed and determined acceptance of all new suppliers and service providers based on compliance with CFR, ISO, and other regulatory bodies.Investigated and conducted root cause analyses on non-conformances observed during sampling or testing of raw materials and finished products. Determined appropriate CAPAs and established effectiveness plans.Evaluated and determined the disposition of raw materials, finished products, and stability studies in accordance with USP/NF and in-house specifications. Verified compliance with FDA and ICH guidances to ensure the safety and efficacy of products manufactured for human or animal consumption.System administrator for LIMS. Performed new user training and account creation. Tasks included troubleshooting, password reset, and updating application configuration and database.Stability program manager. Reviewed/approved stability studies for intermediate and finished products.Developed and maintained performance metrics to report and trend Right the First Time data collected from internal and external departments.

Processed and categorized archaeological samples collected from eastern Nevada.

Directed student study groups, aided with writing compositions, exam review, reading assignments, pronunciation, and individual informal conversations.