Quality Engineer I, Biologics Analytical Services
Core
Provide technical and regulatory expertise to manage quality processes, ensuring patient safety, regulatory compliance, and inspection readiness for biologics manufacturing.
Role type
Quality Engineer I (Biologics Analytical Services)
Builds
Biologics manufacturing and development processes
Domain
Biopharmaceuticals / Life Sciences
Deliverable
client delivery
Required skills
Risk assessment, root cause analysis, CAPA management, regulatory compliance review, investigation management, process improvement
Preferred skills
Cross-functional collaboration, prioritization, problem-solving
Technologies
FDA GMP, ISO standards, QSR/cGMP, WHO guidelines
Responsibilities
Review and manage quality investigations (OOS, OOT, deviations), evaluate issues for risk and identify trends, support corrective and preventive actions (CAPAs), review processes for regulatory compliance, represent the company during regulatory inspections
Seniority
Mid-level, hands-on IC
