Specialist, Quality Assurance (Second Shift)
Core
Ensures pharmaceutical, biologic, and vaccine manufacturing operations comply with quality standards and regulatory requirements through shop floor support, batch review, and deviation management.
Role type
Quality Assurance Specialist (Second Shift)
Builds
Compliant, reliable supply of pharmaceuticals, biologics, and vaccines for global customers and patients.
Domain
Pharmaceutical/Biologics Manufacturing
Required skills
cGMP compliance, Batch Record Review, Deviation Management, Aseptic Techniques, Quality Risk Assessment, Change Control, Environmental Monitoring, Project Management
Preferred skills
Aseptic Manufacturing, SAP/Veeva/GLIMS, Electronic Batch Records, Equipment Qualification, Quality Risk Management
Technologies
SAP, Veeva, GLIMS, Kneat
Responsibilities
Manage project assignments ensuring cGMP compliance; Provide shop floor support for batch review, alarm/incursion response, and deviation management; Execute critical site reviews and environmental monitoring data analysis; Lead shopfloor audits to address compliance gaps; Approve cleaning validation and change controls; Act as Quality Risk Assessment Lead.
Seniority
Mid-level, hands-on IC