QA Officer
Core
QA Officer supporting Validation and Engineering teams in a GMP-regulated environment to ensure quality standards and regulatory compliance for breakthrough discoveries.
Role type
Quality Assurance Officer (GMP)
Builds
Quality systems, validation protocols, and compliant manufacturing processes
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP quality systems knowledge, cGMP regulations knowledge, deviation investigation, CAPA processing, Change Control management, SOP development, risk assessment, protocol issuance
Preferred skills
Quality Assurance experience in GMP settings, biotechnology/biochemistry background
Technologies
Quality Management Systems, validation software
Responsibilities
Review and approve equipment and process validation documents, participate in deviation investigations, approve quality records (deviations, CAPAs, audit findings), update SOPs to meet regulatory standards, support compliance with system timeframes, issue protocols, serve as a resource for operational areas, identify continual improvement opportunities, participate in risk assessments
Seniority
Mid-level, hands-on IC