Ivelisse Colon Perez

Specialist, Qa Gxp Learning and Development @FUJIFILM Biotechnologies

Ventura County, CA, US
MOBILE NUMBERS
+18•••••••20

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WORK HISTORY

Jun 2025 — Present

Specialist, Qa Gxp Learning and Development @FUJIFILM Biotechnologies

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Thousand Oaks, CA, US

Lead interactive GxP course creation and guide new staff through onboarding processes, ensuring alignment with adult learning principles for enhanced knowledge retention.• Collaborate on creating and updating comprehensive curricula for the GMP Learning Management System (LMS), ensuring relevance and continuous improvement. • Utilize ADDIE principles and Agile methodologies to design and craft engaging training materials, fostering effective learning experiences for GxP personnel.• Contribute to internal audits and inspections, reinforcing compliance with regulatory standards and optimizing quality management systems.• Develop and revised training documents, delivering precise communications to management.• Resolve training-related quality issues, such as deviations and CAPAs, enhancing operational standards.• Apply project management skills in site-wide projects, driving successful outcomes and organizational efficiency.• Collaborate with the Document Management Team to optimize the Document Management System (eDMS) for efficient operations.

EDUCATION

2023 — 2025

California State University, Fullerton

Master of Science - MS

2008 — 2011

California Lutheran University

Bachelors Of Science

SKILLS

AnalysisOncologyBusiness ProcessClinical Data ManagementOracle ClinicalDrug DevelopmentGcpBiopharmaceuticalsCross-Functional Team LeadershipChange ControlProject ManagementVisioLife SciencesMs ProjectValidationCdiscBiotechnologyPharmaceutical IndustryBusiness Process ImprovementSopClinical DevelopmentFdaEdcData AnalysisCtmsClinical Trial ManagementData Quality21 Cfr Part 11TrainingManufacturingLifesciencesQuality SystemRupCROClinical TrialsManagementComputer System Validation

ABOUT IVELISSE COLON PEREZ

Results-driven professional with proven success managing projects and implementing…

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