QA Complaints Specialist

Purpose: Our client, a leading biopharmaceutical company, is currently seeking a QA Complaints Specialist.

Responsibilities:

This role will be responsible for maintaining processes and documentation per GXPs and per regulatory requirements for handling complaints related to Depomed, Inc. commercial products. Also responsible for QA Associate activities as assigned for commercial or product development projects. The role will consist of a blend of complaint handling activities, establishing and revising complaint handling systems, and more broad QA Associate tasks.



Essential Functions:

Triage and handling of customer complaints per established procedures in the QA SOPs and in coordination with Depomed and partnered commercial activities. Includes incoming phone calls, emails, and all other complaints from customers and related organizations in the commercial activities.
Review batch records and any associated complaints, deviations, investigations and follow-up activities
Create and maintain batch files; create and maintain tracking databases
Review all other GXP documentation for completeness and compliance to regulatory and procedural requirements

For immediate consideration please email your resume to