Senior QC Engineer, CMC / GMP QA

📋 Description

• Perform detailed quality review of CMC documentation including specifications, batch records
• Review GMP documentation for compliance with FDA, EMA, ICH, and other applicable global regulatory
• Identify documentation gaps, inconsistencies, and compliance risks and recommend corrective actions
• Support QC documentation review activities related to analytical methods, test records, and data
• Provide QC documentation and quality review support for technology transfer activities, as needed
• Support investigations related to QC deviations, OOS/OOT results, and documentation discrepancies

🎯 Requirements

• Bachelor's degree in Chemistry, Engineering, Life Sciences, or related discipline (advanced degree
• Minimum of 10 years of experience in pharmaceutical or biotechnology CMC, GMP, or Quality roles
• Strong hands-on experience reviewing CMC and GMP documentation
• Working knowledge of GMP requirements applicable to drug substance and drug product development
• Experience supporting QC documentation, investigations, and data integrity requirements
• Demonstrated ability to identify documentation gaps and drive corrective actions

🎁 Benefits

• Market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity