Matthew Cole
Quality Specialist @Atara Biotherapeutics
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WORK HISTORY
Quality Specialist @Atara Biotherapeutics
Thousand Oaks, CA, US
Led product disposition for clinical and commercial supply, reviewing CMO batch records and coordinating EU/UK QP releases. Supported BLA/MAA filings and regulatory submissions by reviewing quality sections. Ensured compliance through oversight of CoAs, CAPAs, deviations, change controls, and effectiveness checks.
EDUCATION
Carroll Community College
Business Administration
ABOUT MATTHEW COLE
Document Control leader with 15+ years managing GMP- and CFR-compliant documentation and electronic document management systems (eDMS) across life sciences, healthcare, transportation, and infrastructure projects. Proven expertise in driving audit readiness, regulatory compliance (cGMP, cGDP, 21 CFR), and quality system improvements through SOP management, batch record review, deviation investigations, and ERP system enhancements (Dynamics 365). Skilled in cross-functional collaboration, training development, and process optimization to support clinical supply chains, large-scale infrastructure projects, and import/export compliance.
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