Quality Analyst

Role Summary: The Quality Analyst will be responsible for ensuring that all clinical research activities conducted by Lambda Therapeutic Research adhere to Good Clinical Practice (GCP), regulatory requirements, and internal Standard Operating Procedures (SOPs). This role is critical in maintaining the integrity and quality of clinical trial data and processes.

Key Responsibilities:

• Conduct internal audits of clinical trial documentation, processes, and systems.
• Review and assess compliance with GCP, ICH guidelines, and relevant regulatory standards.
• Identify deviations from SOPs and regulatory requirements, and document findings.
• Participate in the development and implementation of corrective and preventive actions (CAPA).
• Assist in the preparation for external audits (e.g., regulatory authority inspections, client audits).
• Contribute to the review and update of SOPs and quality documents.
• Provide training and guidance on quality standards and compliance to study teams.
• Maintain quality assurance records and documentation.