- Interacts with complainants and obtains essential information required to document technical complaints
- Provides customer service and support to meet the needs of the complainants
- Evaluates complaints for severity and risk to public safety.
- Monitors and tracks sample receipt from critical complaints.
- Prioritizes complaints for data entry and processing into the department PTC database.
- Utilizes the customer service database to oversee complaint identification and processing.
- Monitors complaint activity for assigned manufacturing sites.
- Interacts with both internal and external manufacturing sites regarding technical complaints and their associated investigations.
- Understands FDA complaint regulations for drug products and medical devices.
- Performs file review and administrative closure for individual complaints.
- Monitors open complaint activity for each manufacturing site.
- Identifies and reports adverse events within one business day to Pharmacovigilance.
- Participates on ad-hoc teams regarding product-specific complaint issues.
- Supports Product Quality Complaint Managers/Director during FDA, regulatory, third party, and internal audits.
- Understands product specific information regarding common product complaints.
- Provides feedback to customers regarding complaint investigations.
