Quality Specialist II - Complaints
Core
Investigate and resolve low to moderate complexity product complaints in a regulated pharmaceutical CDMO environment to ensure compliance with cGMPs and protect patient safety.
Role type
Quality Specialist II (Product Complaints)
Builds
Investigation reports, root cause analysis documentation, and CAPA tracking for pharmaceutical products.
Domain
Pharmaceutical manufacturing / CDMO / cGMP
Required skills
cGMP regulations knowledge, root cause analysis, investigation tools, report writing, cross-functional collaboration, CAPA tracking, regulatory inspection support, data collection and assessment.
Preferred skills
GMP investigation experience, CDMO operations exposure, pharmaceutical or biotechnology industry background.
Technologies
None stated
Responsibilities
Perform product complaint investigations, collect and assess data for root cause analysis, draft investigation reports, escalate quality or safety concerns, support CAPA implementation, collaborate with manufacturing and quality control teams, assist with audit and inspection preparation.
Seniority
Mid-level, working under general supervision
