Tech Stack

Description

You will perform routine quality assurance activities to ensure compliance with FDA GLP regulations and company QMS. You'll conduct audits, review data, and support R&D lab teams in maintaining high technical and process standards.

Requirements

• Bachelor's degree in science, life sciences, pharmaceutical, or related field
• 2-3 years of lab quality assurance experience in GLP-regulated environment preferred
• Working knowledge of FDA 21 CFR Part 58
• Experience auditing raw data and final data reports preferred
• Proficiency in Microsoft Word, Excel, Adobe PDF

Responsibilities

• Ensure compliance with FDA 21 CFR Part 58 and JUUL Labs Global Quality QMS
• Perform GLP study-based in-phase, protocol, and report audits
• Review project data for compliance with test methods, protocols, and SOPs
• Issue QA statements for final reports and maintain GLP archival records
• Conduct scheduled reviews of lab notebooks, logs, equipment, and reagents