Alexandria Childs

Review and verify GMP-regulated microbiological test records supporting batch release and use Veeva to manage deviations and documentation, contributing to root cause investigations, CAPA documentation, and inspection readiness.

Supported environmental monitoring documentation review and compliance with SOPs, partnered on change controls for raw materials, and oversaw gowning qualification documentation and training compliance.

Reviewed assay data and QC documentation for regulatory alignment, performed endotoxin, sterility, and microbial ID testing, and drafted endotoxin protocols to support regulatory submissions and streamline workflows.

Executed antimicrobial effectiveness and water testing under GMP protocols, documented results, supported deviation resolution, and reviewed batch records to support sterility monitoring and data integrity.

Managed controlled documentation within a large QA archive initiative, ensured GDP and data integrity compliance, and developed tracking systems to improve accessibility and inspection readiness.

Conducted data extraction, statistical modeling, and structured reporting using RStudio, producing analytical reports and presentations summarizing research findings.

Facilitated regulated donor screening and documentation in a high-volume compliance environment, performed vital sign and hematocrit measurements, and ensured donor safety through proper procedures.

Activities and societies: Core competencies: batch record review & release support, deviation investigation & CAPA documentation, electronic quality systems (Citrix, Veeva), controlled document management, inspection readiness, environmental monitoring, data integrity & GDP.

Completed a Bachelor of Science in Biobehavioral Health with coursework and competencies related to regulatory documentation, quality systems, and environmental monitoring.