Specialist III, QA Operations (Contract)

📋 Description

• Review, evaluate, and approve batch records and data prior to lot release.
• Ensure manufacturing/testing activities comply with cGMP and regulatory requirements.
• Oversee lot disposition processes for materials produced internally and by CMOs.
• Review data generated by CMOs, including in-process and release testing results.
• Evaluate CTLs and in-house data to verify specs and regulatory expectations.
• Confirm deviations, investigations, and change controls are resolved before disposition.

🎯 Requirements

• Bachelor's degree in a scientific discipline or equivalent experience.
• Minimum 5 years QA experience in the pharmaceutical, biotechnology, or related regulated industry, including experience with lot disposition.
• Experience working with CMOs and CTLs in a cGMP environment preferred.
• Strong understanding of cGMP, ICH guidelines, and applicable regulatory requirements.
• Proficient in reviewing manufacturing batch records, analytical data, and quality documentation.
• Proficiency with electronic quality management systems (e.g., MasterControl).