Quality Associate, QA Operations
Core
Support QA Operations for CDMO drug product manufacturing and critical materials in GMP-regulated environments to ensure regulatory compliance and product quality.
Role type
Quality Associate (QA Operations)
Builds
GMP-compliant cell and gene therapy products (e.g., OBX-115 TIL therapy)
Domain
Biotechnology / Cell and Gene Therapy / CDMO Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Batch record review, deviation analysis, root cause analysis, cGMP knowledge, change control support, CAPA tracking, inspection readiness, supplier quality agreement review
Preferred skills
Experience in QA/QC or manufacturing, knowledge of CMC regulatory considerations
Technologies
GMP systems, batch record repositories, quality management software
Responsibilities
Coordinate QA support across manufacturing operations, review batch data and escalate issues, maintain and archive batch records, support change controls and investigations, participate in inspection readiness, contribute to process improvement initiatives, support supplier quality agreement reviews
Seniority
Mid-level, hands-on IC
