Quality Assurance Specialist

📋 Description

• Ensure compliance with protocols, regulations, SOPs.
• Review protocols, informed consents, and CRFs.
• Coordinate with international coordinators and PMs for documentation.
• Audit study materials and procedures for GCP/ICH compliance.
• Audit master files, source data, and SOPs for QA compliance.
• Support lab safety and prompt corrective actions for unsafe conditions.

🎯 Requirements

• Bachelor’s degree and 1-3 years relevant experience
• Understanding of clinical studies
• Excellent organizational, detail-oriented, interpersonal skills; multi-tasking
• Knowledge of GCP ICH/GLP guidelines and Federal Regulations; NIH training

🎁 Benefits

• Equal Opportunity Employer
• Disability assistance available for applicants