GMP Data Reviewer

Job Summary

A company is looking for a Data Reviewer - GMP, Small Molecule.

Key Responsibilities

• Evaluate laboratory data for compliance with analytical methods, client directives, and SOPs
• Review sample results for scientific soundness, completeness, and accurate representation of data
• Communicate with laboratory staff to maintain the quality of laboratory documentation and advocate for quality improvements

Required Qualifications

• Bachelor's degree or equivalent relevant formal academic/vocational qualification
• Previous experience comparable to 2+ years in a GMP regulated laboratory environment
• Demonstrated experience with HPLC data review and Empower strongly preferred
• Thorough knowledge of SOPs and Federal Regulations including GLP and GMP
• Strong technical knowledge of laboratory procedures, methodology, and standards