Quality Associate II

Quality Associate II

12 month contract

Must be able to work on a W2

On-site in Princeton, NJ

Requirements

• Ensures GMP compliance for outsourced clinical manufacturing, packaging, labeling, and testing activities.

• Performs QA review of small molecule Drug Product manufacturing and/or packaging batch records for OPDC Investigational Development Product (IMP) and/or Commercial Product for accuracy and compliance with Otsuka and GMP requirements.

• Utilizes the TrackWise Digital eQDMS System to enter batch related information and complete associated batch disposition workflow.

• Escalates project/supplier issues/trends to GPQ Management when appropriate to ensure timely resolution.

• Works collaboratively with OPDC Vendors as well as the GPQ Department and other functional areas across Otsuka Affiliates and Subsidiari...