Quality Specialist II - Complaints
Core
Investigate and resolve low to moderate complexity product complaints in a regulated pharmaceutical CDMO environment to ensure compliance and patient safety.
Role type
Quality Specialist II (Product Complaints)
Builds
Investigation reports, root cause analysis documentation, and CAPA tracking records
Domain
Pharmaceutical manufacturing / CDMO / cGMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP regulations knowledge, root cause analysis, investigation documentation, CAPA tracking, cross-functional collaboration, regulatory inspection support
Preferred skills
GMP investigation experience, CDMO operations exposure
Technologies
None stated
Responsibilities
Perform product complaint investigations, collect and assess data for root cause analysis, draft investigation reports, escalate quality concerns, support CAPA implementation, collaborate with manufacturing and quality control teams, assist with audit preparation
Seniority
Mid-level, hands-on IC
