Specialist I, QA Operations
Core
Ensuring compliance with regulatory requirements and maintaining quality standards for AAV gene therapy manufacturing operations.
Role type
Specialist I, QA Operations (AAV Manufacturing)
Builds
cGMP-compliant AAV gene therapy products
Domain
Biotechnology / Gene Therapy / cGMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Batch record review, SOP revision, deviation management, root cause analysis, CAPA implementation, audit support, cleanroom operations, regulatory compliance
Preferred skills
cGMP manufacturing experience, biologics production knowledge, eQMS usage (Veeva Vault), internal/external audit participation
Technologies
Veeva Vault, Microsoft Office (Outlook, Teams, Word, Excel, PowerPoint)
Responsibilities
Review and approve batch records and controlled documentation for AAV manufacturing; Provide training and guidance to manufacturing personnel on quality procedures; Support deviations, root cause analysis, and CAPA measures; Collaborate with cross-functional teams for process improvement; Assist in preparation for external audits and inspections; Maintain QA presence in cleanroom manufacturing areas.
Seniority
Individual Contributor, Entry to Mid-level