Data Reviewer - GMP Lab

Job Summary

Working remotely in a full-time capacity, the Data Reviewer - GMP Lab will evaluate laboratory data for compliance with analytical methods and Good Manufacturing Practices (GMP), ensuring accuracy and quality in the review of complex analytical analysis experiments on pharmaceutical and biopharmaceutical compounds.

Key responsibilities

• Evaluates laboratory data for compliance with analytical methods, client directives, and SOPs
• Reviews sample results for scientific soundness and accurate representation of data
• Communicates with laboratory staff to maintain the quality of laboratory documentation and escalates significant deficiencies

Required qualifications

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification
• Previous experience in a GMP Lab with formal data review (2+ years preferred)
• Thorough knowledge of SOPs and Federal Regulations including GLP and GMP
• Strong technical knowledge of laboratory procedures and methodologies
• Ability to independently review laboratory reports and analytical methods