Associate Quality Complaints
Core
Own and implement the end-to-end global complaint process and management system, ensuring compliance with quality operating standards and translating market information for continuous improvement.
Role type
Associate Quality Complaints Specialist
Builds
Global complaint management systems and processes
Domain
Biotechnology / Pharmaceutical Quality Management
Deliverable
dashboards & analysis
Required skills
Complaint investigation, record evaluation, triage, void process management, SOP adherence, project task management, document review/approval, process management systems, MS Office, quality system understanding
Preferred skills
Quality/manufacturing experience in biotech/medical device/pharma, matrixed environment navigation, manufacturing/testing process knowledge (API, Drug Substance, Drug Product, Packaging, Device)
Responsibilities
Evaluate and manage customer feedback records to closure, determine if complaints require critical issue escalation, complete assigned assessments per procedures, ensure quality of complaint records, drive complaint process per SOP requirements, own or handle review/approval process flow in CDOCS, support management of assigned projects or project tasks
