QA Complaints Supervisor
Edison-New Brunswick Metro Area, NJ
- Relevant college or university degree in a scientific study preferred.
Minimum 7 years relevant work experience in a GMP Quality organization and a minimum of 3 years of supervisory experience preferred.
Previous experience working with Product Quality Complaint process required.
- Responsible for process and system ownership of the Product Quality Complaint (PQC) quality system element. In this role, the incumbent will serve as business process owner for the eQRMS electronic complaint handling module and associated governing procedures.
- Function as the Quality System Owner for the Product Quality Complaint system and all associated processes
Must have expert GMP and Quality knowledge, particularly in the area of Product Quality Complaint handling.
Must be able to function as SME for Product Quality Complaints within the organization.
Must be familiar with the roles and responsibilities of Drug Safety and Medical Affairs within a pharmaceutical/biopharmaceutical company.
Must have an operational knowledge, including life cycle management experience, of common electronic quality system platforms, preferably EtQ, Documentum, and ComplianceWire.
Must be able to effectively prepare communications with interpretation of data analysis and potential problems to appropriate audience, with clarity and a high level of accuracy.