Quality Assurance Engineer
Core
Ensure quality, compliance, and operational excellence across GMP manufacturing environments for gene therapy products.
Role type
Quality Assurance Engineer (GMP Manufacturing)
Builds
Compliant gene therapy manufacturing operations
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP regulations, regulatory inspections, commissioning/qualification/validation, deviation/CAPA/change control management, SOP authoring, quality documentation review
Preferred skills
Cross-functional collaboration, technical writing, problem-solving
Technologies
GMP, FDA regulations, QMS, SPC
Responsibilities
Provide QA support for clinical and commercial gene therapy manufacturing; Ensure compliance with GMP, FDA, and global regulatory requirements; Partner with Engineering, Validation, and Operations to maintain a compliant manufacturing environment; Support internal, customer, and regulatory audits and inspection readiness initiatives; Review and approve change controls, deviations, investigations, and CAPAs; Provide quality oversight for facility, utility, equipment, and process qualification activities; Author, review, and approve SOPs and quality documentation supporting GMP operations.
Seniority
Mid-Senior, hands-on IC
