QA Specialist – Finished Product (18 Month FTC)

Job description

Introduction to role: Are you ready to turn rigorous quality oversight into real-world impact for people relying on life-changing medicines? Do you want to see the outcomes of your work in safe, reliable product reaching patients on time? As QA Specialist for Finished Product at our College Park site, you will safeguard the integrity of commercial and clinical packaging and labelling activities. You will connect day-to-day batch documentation and deviation management with the broader mission of uninterrupted, compliant supply for patients with rare and devastating conditions. Working closely with cross-functional partners and Qualified Persons, you will ensure our testing, packaging, storage and release processes meet our Quality Management System and all applicable regulations. Accountabilities: Batch Documentation Oversight: Issue and review batch documentation for finished product packaging, ensuring completeness, accuracy and timely progression to release for both commercial and clinical supply. Deviation and CAPA Leadership: Provide quality input, oversight and guidance to deviations and investigations to drive robust root cause analysis, effective CAPAs and on-time closure in...