QA Specialist – 12 Month FTC
Core
Provide end-to-end quality oversight for commercial manufacturing of biologics, ensuring safety, compliance, and batch release.
Role type
Quality Assurance Specialist (Pharmaceutical Manufacturing)
Builds
Safe, compliant biologics batches ready for patients
Domain
Pharmaceutical/Biologics Manufacturing
Required skills
cGMP oversight, batch record review, validation review, SOP approval, quality risk assessment, inspection readiness, QMS management, supplier management, material release, quality metrics reporting
Preferred skills
Cross-functional influence, complex matrix navigation, leadership presence
Technologies
Electronic batch record systems, QMS software
Responsibilities
Review and approve executed and master batch records; Review and approve technical documentation (cleaning, process, method validation); Participate in quality risk assessments; Support inspection readiness and engage with health authority inspectors; Oversee QMS elements (deviations, change control, calibration, preventive maintenance); Author and approve quality procedures; Review and release raw materials and components; Develop and report quality metrics
Seniority
Mid-level, hands-on IC
