Justin Smith
Director GMP QA
- Role
- Senior Quality Assurance Manager at Takeda
- Location
- Madison, WI, US
- LinkedIn followers
- 500 followers
About Justin Smith
At Takeda, my role as Quality Assurance Manager is integral to maintaining exemplary…
Experience
Senior Quality Assurance Manager
Jan 2019 — Present · Boston, MA, US
Managed all quality functions (Batch Records, LIRs, OOS, Investigations, Deviations, CAPA, and Change Controls) at CDMOs for 10 cell banks, 1 drug substance, 3 processing aids, and 3 sterile drug products including receipt, manufacturing, testing/release, inspection, and labeling.o Reduced cycle times for change control approval by 25%o Maintained on time release of 60 batches per year. o Acted as Person-in-Plant during drug product and drug substance manufacturing.o Maintained QA oversight over cell-bank stability program performed by CMO. Supported cell bank tech transfers, and investigations requested by drug substance sites related to cell banks. o Maintained oversight of PQR program, approved final annual PQRs for two siteso Provided Quality Oversight for external CMO project teams, maintaining robust relationships with the CMO by conducting periodic visits, leading quality interactions during business review meetings, and tracking key performance indicators for sites.o Partnered with technical services to identify and resolve critical manufacturing issues, enabling the implementation of CAPAs that reduced supply impacting OOS, Chromatography, Yield, Bioburden, and Particulate events. Achieved improvements in average Right-First-Time (RFT) performance from 60% to 100% in certain processes
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