
Regulatory Affairs–focused biotechnology professional with hands‑on experience in USDA‑regulated biologics testing, aseptic technique, sterility assurance, and quality documentation at Ceva Animal Health. Strong scientific reasoning, documentation skills, and deep understanding of biologics production and compliance requirements. Adept at cross‑functional collaboration, data integrity, and supporting product quality throughout development and manufacturing. Known for accuracy, analytical thinking, and the ability to learn complex regulatory frameworks quickly.
· Perform ELISA assays, titrations, growth promotion, and egg candling to support potency, purity, and safety assessments.
· Enter and review data in LIMS, ensuring complete, accurate, and compliant documentation for regulatory submissions and audits.
· Review QC documents for completeness, adherence to SOPs, and readiness for regulatory inspection.
· Support investigations by providing accurate test results and documentation for QA and Manufacturing.
· Trained new employees in QC processes.
· Trained in production outline
Internship / Shadowing
Ceva Animal Health – Lenexa, KS