Manufacturing Quality Specialist (2nd Shift)
Core
Ensures quality and compliance of oligonucleotide products throughout the manufacturing process, implementing process controls and audits.
Role type
Manufacturing Quality Specialist
Builds
Oligonucleotide products for regulated industries
Domain
Pharmaceutical/Medical Device manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CAPA management, root cause analysis, process audits, nonconformance management, KPI reporting, QMS support, equipment validation, regulatory compliance (21 CFR 820, ISO 9001, ISO 13485)
Preferred skills
Quality management software proficiency, risk management tools, manufacturing process familiarity
Technologies
Quality management software, risk management tools
Responsibilities
Investigate customer complaints and manage product returns, perform final QC checks on special orders, conduct manufacturing process audits, lead CAPA initiatives, monitor and report manufacturing KPIs, support QMS tasks like document control and change management, train production staff on quality standards
Seniority
Mid-level, hands-on IC
