Stacey Orellana
Livermore,CA
Summary
Results-driven GxP Training Specialist with 4 years in the biopharmaceutical industry. Experience in managing and optimizing LMS systems, designing e-learning modules, and developing comprehensive training programs. Adept at creating automated workflows, conducting FDA-required training, and ensuring compliance with GxP standards. Known for a meticulous approach to instructional design, excellent communication skills, and a commitment to fostering a culture of continuous improvement and excellence.
Overview
4
4
years of professional experience
Work History
GxP Training Specialist
Minaris Regenerative Medicine
2023.01 - Current
- Manage Veeva LMS, including curriculum/learner role creation, report building, and maximizing system utilization and automation.
- Design and implement comprehensive e-learning modules using advanced instructional design principles and multimedia production.
- Develop and automate training workflows for GxP documentation, streamlining processes and reducing manual input.
- Create detailed training manuals, interactive video content, and blended learning solutions.
- Perform end-to-end testing on LMS updates and implement changes in a quarterly change control cycle.
- Collaborate with management to update curriculum, reflecting departmental changes and reducing training gaps.
- Create and conduct FDA-required annual GxP refresher training.
- Design and implement a Qualified Trainer Program and a Train the Trainer program.
- Review and approve all training materials and audit training/trainers to ensure high-quality instruction.
Site Technical Trainer
Minaris Regenerative Medicine
2021.11 - 2023.01
- Conducted new hire onboarding training, including unit-based training and qualifications.
- Trained Cell and Gene Therapy Associates on all equipment and procedures.
- Created curriculum, presentations, training videos, and conducted workshops for classroom training.
- Trained entire site on new equipment and software/systems.
- Achievements:100% pass rate for all new hires in qualifications (gowning and aseptic).
No recurring incidents in CAPA re-trainings and workshops.
Received an "Outstanding" performance review for 2022.
Manufacturing Associate I
Minaris Regenerative Medicine
2020.08 - 2021.11
- Processed up to 6 different cell/gene therapy projects with advanced aseptic techniques and cleanroom behavior (0 human errors per year).
- Led the Social Committee and Safety Committee at the Mountain View site.
Education
Bachelor of Science - Molecular, Cell And Developmental Biology
University of California - Santa Cruz
Santa Cruz, CA06.2020
Skills
- Learning Management Systems (Veeva & QT9)
- Training Program Development/ Design
- Microsoft Office Suite (Word, Outlook, Teams, PowerPoint)
- Presenting and Public Speaking
- Good Manufacturing Practices (GMP/GDP)
- Aseptic Technique
- Bilingual: English/Spanish
- Strong Writing and Documentation Skills
- Video Editing and Multimedia Production
Timeline
GxP Training Specialist
Minaris Regenerative Medicine
2023.01 - Current
Site Technical Trainer
Minaris Regenerative Medicine
2021.11 - 2023.01
Manufacturing Associate I
Minaris Regenerative Medicine
2020.08 - 2021.11
Bachelor of Science - Molecular, Cell And Developmental Biology
University of California - Santa Cruz
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