Associate III, Quality Technical Product Complaints
Core
Process product complaints, coordinate sample evaluations, and drive investigations to ensure product quality and patient safety compliance.
Role type
Associate III, Quality Technical Product Complaints Specialist
Builds
Compliant complaint handling workflows and root cause analysis outcomes for global markets
Domain
Biotechnology / Pharmaceutical Quality Assurance
Deliverable
client delivery
Required skills
cGMP environment experience, root cause analysis, risk assessment, cross-functional collaboration, written and verbal communication
Preferred skills
biologics complaint handling, FDA/EMA/ISO regulations knowledge, CAPA management, risk management principles, quality tools (5 Whys, Fishbone, Fault Tree)
Technologies
None explicitly stated
Responsibilities
Respond to complaint inquiries, process incoming cases and coordinate sample shipments, analyze complaint data and identify trends, review customer inputs for compliance, conduct investigations using structured methodologies, evaluate samples and document results per cGMP, track and support CAPA implementation
Seniority
Associate III, hands-on IC
