Quality Assurance Specialist, Batch Disposition
Core
Lead batch review and disposition activities to ensure quality, compliance, and timely release of clinical and commercial biopharmaceutical products.
Role type
Quality Assurance Specialist (Batch Disposition)
Builds
Clinical and commercial biopharmaceutical products
Domain
Biopharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP regulations, batch record review, deviation management, CAPA management, Change Control, regulatory inspection support, aseptic fill-finish processes, cell culture, purification
Preferred skills
Quality Management Systems (QMS), Statistical Process Control (SPC), Standard Operating Procedure (SOP) authoring
Responsibilities
Lead batch record review and disposition; make quality-based disposition decisions for raw materials and finished products; partner with Manufacturing and Quality teams for GMP compliance; support release of clinical and commercial products; issue and manage batch records; review and approve SOPs and specifications; drive investigations, deviations, CAPAs, and Change Controls; support internal audits and FDA inspections; monitor quality metrics.
Seniority
Mid-level, hands-on IC