Quality and Regulatory Specialist - Flamability Lab
Core
Ensuring compliance with quality standards, federal regulations, and industry guidelines (GCP, GLP, ISO 17025) for clinical trials and laboratory operations.
Role type
Quality and Regulatory Specialist
Builds
Compliance documentation, audit reports, and risk management strategies for clinical studies and lab procedures.
Domain
Clinical research / Laboratory quality assurance
Deliverable
dashboards & analysis
Required skills
Regulatory compliance knowledge, internal auditing, risk assessment, SOP development, documentation management, staff training
Preferred skills
Supervisory experience, Engineering Technology background
Technologies
None stated
Responsibilities
Review protocols, informed consents, and CRFs; conduct internal audits of clinical trial master files and source data; prepare and submit documentation to regulatory agencies; investigate non-compliance issues and develop corrective actions; train staff on quality and regulatory standards; assess operational risks.
Seniority
Mid-level individual contributor