Salma Abdel-Azim
Associate Process Support Scientist @Regeneron
Signup · Get unlimited contacts
WORK HISTORY
Associate Process Support Scientist @Regeneron
Rensselaer, NY, US
Lead root cause investigations into deviations impacting product quality, safety, and regulatory compliance across upstream, downstream, and fill/finish manufacturing-Draft investigational reports and technical documentation aligned with internal SOPs, GMP standards, and data integrity expectations to support product release decisions-Monitor process data using R and JMP to identify quality trends and recurring risk signals, providing early insights for issue escalation and mitigation planning-Collaborate with QA and manufacturing teams to assess CAPA plans, ensure effective resolution of quality issues, and evaluate the impact of changes on compliance status-Support readiness efforts by identifying documentation gaps, synthesizing findings, and contributing to cross-functional discussions around quality risk posture and remediation-Provide guidance to business users through technical documentation and job aids on GMP tools and investigation workflows, promoting consistent risk evaluation and resolution processes.
EDUCATION
The Johns Hopkins University
Bachelor's degree, B.S. in Molecular and Cellular Biology & B.A. in Public Health Studies
New York University
Master of Science - MS, Epidemiology
ABOUT SALMA ABDEL-AZIM
Johns Hopkins alumna with a B.S. in Molecular and Cellular Biology and Public Health…
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.