GMP Data Reviewer

Job Summary

Working remotely on a full-time basis, the GMP Data Reviewer will evaluate laboratory data for compliance with analytical methods and protocols while ensuring adherence to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).

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 advocates for quality improvements

Required qualifications

• Bachelor's degree or equivalent relevant qualification
• Minimum of 2 years of relevant experience in a GMP laboratory setting
• Demonstrated knowledge of PCR and sequencing
• Experience with method validation and chromatographic review, particularly using Empower
• Thorough knowledge of SOPs and Federal Regulations, including GLP and GMP