Validation Analyst, Labs
Core
Ensure the accuracy, reliability, and compliance of laboratory processes and systems supporting clinical trials.
Role type
Validation Analyst II (Labs)
Builds
Validated laboratory instruments, equipment, and software systems for clinical trials
Domain
Healthcare / Clinical Research / Laboratory Operations
Required skills
Laboratory validation, Quality assurance, Regulatory compliance (FDA, EMA, ICH), Validation methodologies, Quality management systems, Data analysis, Problem-solving
Preferred skills
None stated
Technologies
None stated
Responsibilities
Develop and execute validation protocols and test plans for laboratory instruments, equipment, and software systems; Conduct validation testing, data analysis, and documentation in accordance with regulatory requirements; Identify and troubleshoot validation issues, deviations, and non-conformances; Provide technical expertise and guidance on validation strategies to project teams; Contribute to the continuous improvement of laboratory processes and validation methodologies
Seniority
Mid-level, hands-on IC
