Kite Pharma R&D Quality Internship

The R&D Quality (RDQ) Internship at Kite Pharma provided me with a comprehensive introduction to ensuring compliance with health authority regulations and fostering a quality-driven culture within clinical research and development. Key contributions included preparing for regulatory inspections by reconciling clinical trial timelines, conducting gap analyses, and developing mock inspection documentation. I also supported Standard Operating Procedure (SOP) updates to enhance consistency and developed engaging training materials, such as the Quality GCP Training Game, to strengthen employee understanding of Good Clinical Practices (GCP) across departments and functional areas. Additionally, I conducted a training gap analysis to assess current GCP audit report writing skills and support the future creation of team training materials. Overall, this internship reinforced the importance of quality in protecting patients, ensuring product reliability, and managing risks in the development of innovative therapies, and further fueled my interest in the field of Quality.

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Publication Details

Journal
PDA Journal of Pharmaceutical Science and Technology
Published
2025-01-01
DOI
https://doi.org/10.5731/pdajpst.2025.25404
Primary Topic
Biomedical and Engineering Education
Type
article
Field-Weighted Citation Impact
0.00
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article

Kite Pharma R&D Quality Internship

Caroline Fisher, Matt Stevenson, Douglas Cooper
PDA Journal of Pharmaceutical Science and Technology
Biomedical and Engineering Education
article

Kite Pharma R&D Quality Internship

Caroline Fisher, Matt Stevenson, Douglas Cooper
article en

Abstract

The R&D Quality (RDQ) Internship at Kite Pharma provided me with a comprehensive introduction to ensuring compliance with health authority regulations and fostering a quality-driven culture within clinical research and development. Key contributions included preparing for regulatory inspections by reconciling clinical trial timelines, conducting gap analyses, and developing mock inspection documentation. I also supported Standard Operating Procedure (SOP) updates to enhance consistency and developed engaging training materials, such as the Quality GCP Training Game, to strengthen employee understanding of Good Clinical Practices (GCP) across departments and functional areas. Additionally, I conducted a training gap analysis to assess current GCP audit report writing skills and support the future creation of team training materials. Overall, this internship reinforced the importance of quality in protecting patients, ensuring product reliability, and managing risks in the development of innovative therapies, and further fueled my interest in the field of Quality.

PDA Journal of Pharmaceutical Science and TechnologyVol. 79(4)
Keck Graduate Institute (US)
Openalex Percentile: Top 82%
Biomedical and Engineering Education
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Kite Pharma R&D Quality Internship — Caroline Fisher, Matt Stevenson, et al. · PDA Journal of Pharmaceutical Science and Technology (2025) | TGRS Research Map | TGRS