Data Reviewer, Quality Control

Job description

Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Data Reviewer, Quality Control ’s main responsibility will be to review Quality Control analytical data. In this role you will: - Conduct a comprehensive and critical evaluation on QC data in Empower and SoftMax Pro software including but not limited to contents, results, data accuracy, and scientific relevance, format and adherence to cGMPs. - Perform a thorough review of raw data, including electronic raw data and documentations to ensure compliance with applicable specifications and/or protocols. - Conduct GMP review of laboratory notebooks, logbooks, and associate forms. - Conduct GMP review of electronic raw data to ensure compliance with data integrity policies. - Support OOS/OOT investigations. - Support internal and external audit. - Support QC method validation review, as needed. - Perform review of procedural and method revisions, where necessary. - Perform other duties as assigned...