Quality Engineer III
Core
Quality Engineer supporting quality assurance for clinical and commercial manufacturing programs in a regulated environment.
Role type
Senior IC Quality Engineer (GMP)
Builds
compliant pharmaceutical/biotech products
Domain
Life Sciences / Biopharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, root cause analysis, CAPA management, change control, validation activities, risk assessment, statistical analysis, technology transfer support, audit participation
Preferred skills
biologics manufacturing experience, process validation expertise, customer audit support, statistical process control
Technologies
Microsoft Office, Quality Management Systems
Responsibilities
Review and approve GMP documentation (batch records, deviations, CAPAs), lead quality investigations and root cause analyses, evaluate quality metrics for process improvements, participate in risk assessments and quality planning, support technology transfer and new process implementation, conduct internal and customer audits
Seniority
Senior, hands-on IC