We are seeking a QA Senior Associate to oversee batch record review and disposition of clinical and commercial BDS lots for RNA therapies. This role ensures compliance with FDA, ICH, and internal regulations, manages deviations and investigations, and supports continuous improvement initiatives.
Key Responsibilities:
Review and approve CMO manufacturing records, Certificates of Analysis, deviations, and OOS reports.
Support CMO manufacturing operations, ensuring timely issue resolution.
Perform data entry for lot release metrics and contribute to inspection readiness.
Escalate critical issues and support SOP/policy revisions.
Qualifications:
BS/MS in Biology with 4+ years of cGMP experience.
Knowledge of FDA, EU, ATMP, and JP regulations.
Detail-oriented with excellent communication and MS Office skills.
Join us to make an impact in advancing RNA therapies!