Senior Specialist, QA Technical Operations
Core
Provide quality oversight and support for technology transfer, automation, cell bank disposition, validation, and manufacturing science programs at a biotech production site.
Role type
Senior Specialist, QA Technical Operations
Builds
Biotech bulk and finished products in compliance with cGMP regulations
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP regulations knowledge, Quality Risk Management, SOP review, CAPA management, change control, regulatory audit preparation, performance management, technical transfer oversight
Preferred skills
Biotech manufacturing knowledge, electronic systems (SAP, LIMS, Veeva Vault, Maximo), US/EU regulatory guidance
Technologies
SAP, LIMS, Infinity (Veeva Vault), LES, Maximo, Vault, Syncade
Responsibilities
Review and approve investigations and change controls; Provide quality oversight for technology transfer and validation; Perform review of Quality, Manufacturing, and Material Specifications SOPs and batch records; Support regulatory audits and inspections; Establish performance objectives for QA staff; Provide strategic foresight for continuous improvement
Seniority
Senior, hands-on IC with team management
