Manufacturing Quality Specialist (2nd Shift)
Core
Ensures quality and compliance of oligonucleotide products throughout the manufacturing process per ISO 13485, ISO 9001, and 21 CFR 820.
Role type
Manufacturing Quality Specialist
Builds
Oligonucleotide products
Domain
Pharmaceutical manufacturing / Life Sciences
Required skills
Quality audits, Nonconformance management, Root cause analysis, CAPA management, KPI monitoring, QMS support, Process improvement, Equipment validation
Preferred skills
Quality management software, Risk management tools, Manufacturing equipment familiarity
Responsibilities
Investigate customer complaints and manage product returns, Perform final QC checks on VIP/Special projects, Conduct manufacturing process audits, Lead CAPA initiatives and root cause analysis, Monitor and report manufacturing KPIs, Train production staff on quality standards
Seniority
Mid-level, hands-on IC
