31 Jul
|
Sitero
|
Markham
Join Sitero as a Senior Quality Assurance Associate, blending hybrid work in Mississauga with essential GCP compliance and TMF management expertise. Ensure adherence to regulatory standards while supporting quality in clinical trials.
This full-time role focuses on quality assurance compliance across multiple therapeutic areas. Ideal candidates will have 2-4 years of experience in clinical research QA or TMF management, utilizing their understanding of ICH-GCP guidelines to maintain quality during studies. You will also assist in preparing teams for inspections and promote compliance awareness.
Key Responsibilities:
• Perform regular quality checks on the Trial Master File (eTMF)
• Review site-level essential documents for compliance
• Conduct internal quality reviews adhering to ICH-GCP
• Identify documentation errors and implement CAPAs
• Assist in preparing for regulatory inspections
Requirements:
• Bachelor’s degree in life sciences or a related field
• 2-4 years of clinical research QA experience
• Deep understanding of ICH-GCP guidelines
• Exceptional attention to detail and problem-solving skills
• Strong communication skills for compliance findings
Drive quality assurance and compliance initiatives at Sitero, contributing to cutting-edge clinical solutions.
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📌 Hybrid Senior Quality Assurance Associate (Markham)
🏢 Sitero
📍 Markham