QA Operations Specialist III

The Specialist III, QA Operations is responsible for ensuring compliance with cGMP and regulatory requirements in the review and approval of batch records and data prior to lot release. This role involves overseeing lot disposition processes for materials produced internally and by Contract Manufacturing Organizations (CMOs).

Key Responsibilities

• Review, evaluate, and approve batch records and data prior to lot release.
• Ensure compliance of manufacturing/testing activities 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 specifications and regulatory expectations.
• Confirm that deviations, investigations, and change controls are resolved before disposition.

Requirements & Qualifications

• Bachelor's degree in a scientific discipline or equivalent experience.
• Minimum 5 years QA experience in the pharmaceutical, biotechnology, or related regulated industry.
• Experience with lot disposition and working with CMOs 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.
• Familiarity with electronic quality management systems (e.g., MasterControl).