QC Technician II - 1st Shift
Core
Sampling, inspecting, and testing raw materials for viral vector therapies to ensure GMP compliance before manufacturing.
Role type
QC Raw Materials Technician
Builds
Viral vector therapies for gene therapy clients
Domain
Biopharmaceuticals / Gene Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, raw material inspection, sample collection and labeling, cleanroom gowning, documentation review, data entry in operating systems, non-conformance investigation support, SOP authoring, training personnel
Preferred skills
GxP environment experience, Pharmacopeia knowledge (USP, EP, JP)
Technologies
SAP, Microsoft Office, Outlook
Responsibilities
Review received goods and document lot numbers/expiry dates, arrange and label raw material samples, perform material transfer and gowning into clean rooms, reconcile test results for material release, identify and escalate non-conformances, review processing documents for GMP compliance, author SOPs and material specifications, train personnel on OJTs
Seniority
Entry-level, hands-on IC
