Roxana Palacios-Toledo
@roxanapalacios-toled
Quality Specialist III at Thermo Fisher Scientific who developed Power BI reporting that saves about an hour of work daily.
United StatesWhat I'm looking for
At Thermo Fisher Scientific, I coordinate CAPA activities, investigations, corrective actions, and Quality Plans. I developed Power BI reporting that connects multiple data sources and saves approximately one hour of work per day.
At Takeda Pharmaceutical Company, I coordinated compliance and inspection-readiness work, including the site Self-Inspection Program and responses to regulatory observations. I also supported process improvements that reduced product-release cycle time from approximately 30 days to 15 days.
Experience
Work history, roles, and key accomplishments
Coordinate CAPA activities, investigations, and corrective actions while managing multiple deadlines. Developed Power BI reporting and consolidated release documentation to improve efficiency.
Senior Quality Compliance Specialist
Mar 2022 - Feb 2025 (2 years 11 months)
Led cross-functional compliance initiatives supporting regulatory inspections and GMP certification readiness. Managed the site Self-Inspection Program and coordinated responses to regulatory observations.
Coordinated QA operations for final drug product manufacturing and disposition. Tracked deviations, CAPAs, change controls, and quality metrics to maintain visibility of commitments.
Senior Quality Analyst – Final Drug Product Release
Mar 2014 - May 2021 (7 years 2 months)
Served as Quality SME for the Advate/Adynovate BAXJECT III product line. Led deviation investigations and process improvements that reduced product-release cycle time from 30 to 15 days.
QA Analyst – Receiving & Inspection
Jan 2011 - Mar 2014 (3 years 2 months)
Performed raw material inspection, disposition, and nonconformance investigations. Issued corrective-action reports and maintained quality documentation.
Education
Degrees, certifications, and relevant coursework
ASQ
Certified Quality Auditor, Quality Auditing
2023 - 2023
Certified Quality Auditor certification from ASQ.
Lean
Lean Green Belt, Lean
2015 - 2015
Lean Green Belt certification.
California Polytechnic University, Pomona
Bachelor of Science, Biotechnology
Bachelor of Science in Biotechnology from California Polytechnic University, Pomona.
Tech stack
Software and tools used professionally
Availability
Location
United StatesAuthorized to work in
Salary expectations
Job categories
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