QA Specialist
Core
Support validation projects from initiation to completion, ensuring equipment, cleaning, analytical, and software processes meet regulatory standards and quality goals.
Role type
Validation Specialist (Life Sciences)
Builds
Validated equipment, processes, and software systems for Life Sciences clients
Domain
Life Sciences / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation project management, risk assessment, cGMP compliance knowledge, regulatory guideline interpretation (FDA/EMA/ISO), validation plan/protocol development, cross-functional coordination, data trend analysis, audit support
Preferred skills
Advanced degrees in validation/quality, proficiency in validation management software, experience with electronic documentation systems, risk management tools
Technologies
Validation management software, electronic documentation systems, risk management tools
Responsibilities
Coordinate with validation managers to meet project goals; develop and implement validation plans, protocols, and procedures; evaluate and approve validation reports; conduct risk assessments and identify mitigation strategies; track and trend validation activities and results; support regulatory inspections and audit responses; mentor Quality, Operations, and Engineering teams on cGMP compliance; participate in Product Quality Reviews
Seniority
Mid-level, hands-on IC
