Senior Associate, Product Development Quality Assurance-Hybrid, Chicago
Core
Support AbbVie's clinical supply pipeline by ensuring high-quality, compliant clinical supplies are delivered to patients through batch disposition and quality oversight.
Role type
Senior Associate, Product Development Quality Assurance
Builds
Clinical supply batches for patient access
Domain
Pharmaceutical manufacturing / Clinical supply chain
Required skills
Batch record review and approval, GxP compliance, audit preparation and management, corrective and preventive actions (CAPA), quality metrics reporting, process improvement, manufacturing floor oversight
Preferred skills
Pharmaceutical manufacturing processes (chemical/biological), analytical sciences, worldwide GMP requirements (D, EU, US), complex activity coordination
Technologies
Materials management systems
Responsibilities
Review and approve batch records and release batches or analytical records; Lead/assist in preparation and management of audits; Provide quality approvals in materials management systems; Review/approve clinical documentation and specifications; Actively lead/participate on project teams to resolve quality issues; Generate and report quality metrics; Monitor process effectiveness and execute improvements; Provide quality oversight on the manufacturing floor
Seniority
Senior, hands-on IC
