QC Analytical Specialist

Job Summary

A company is looking for a Specialist, QC Analytical.

Key Responsibilities

• Advise contract testing laboratories on method development, validation, transfer, and quality investigations
• Review QC stability and lot release data, and create batch release certificates of analysis
• Author and review documentation related to analytical methods and regulatory submissions

Required Qualifications

• Bachelor's degree with 8+ years or Master's degree with 6+ years in Analytical Chemistry or related discipline
• Experience in method development, validation, transfer, and stability programs
• Strong knowledge of quality control analytical methods and pharmaceutical regulations
• In-depth knowledge of GMPs and relevant guidelines
• Technical writing experience for SOPs and analytical test methods