QC Data Reviewer - LNP and Lipids

📋 Description

• Review analytical data packages from stability studies, method development, and investigations for
• Evaluate OOS/OOT investigation reports for completeness and scientific soundness.
• Verify calculations, data transcriptions, and chromatographic data for accuracy and regulatory
• Ensure documentation adheres to GMP and applicable regulatory guidelines.
• Maintain review timelines and tracking logs to support release and regulatory submission deadlines.
• Partner with analytical and quality teams to resolve data discrepancies and review findings.

🎯 Requirements

• B.S. in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field with 3-4 years of GMP
• Proficiency in GMP regulations and Good Documentation Practices.
• Understanding of chromatography operation and data interpretation.
• Strong organizational, time management, and cross-functional collaboration skills.
• Effective communication and documentation skills.

🎁 Benefits

• Excellent full-time benefits including medical, dental, vision, life and disability insurance.
• 401(k) with company match, paid vacation and holidays.
• Salary range: $36.00-$40.00 per hour, dependent on education/experience.