Quality Specialist
Core
Ensuring manufacturing processes meet world-class standards and upholding ISO 9001 quality systems for antigens and antibodies.
Role type
Senior Quality Specialist (Medical Device/Pharma)
Builds
Diagnostic and biopharmaceutical products
Domain
Biotechnology / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO 9001 compliance, CAPA management, NCR handling, Deviation management, Internal auditing, Supplier quality auditing, Change control, Documentation control, Quality trend analysis, SOP development, Health and Safety compliance
Preferred skills
ISO 13485 familiarity, ISO 14971 familiarity, Lab jacket and PPE usage
Technologies
VirtuE expression system
Responsibilities
Perform internal audits and supplier quality audits as site Lead Auditor; Support external audits (Notified Body, Customer); Monitor and assess suppliers/distributors; Update and approve quality documentation (SOPs, Batch Records); Utilize quality tools to track and trend performance; Conduct Management Reviews and follow-ups on actions.
Seniority
Senior, hands-on IC