QC Analytical Data Reviewer, Pharma - Remote

Job summary

The Data Reviewer role at The*** involves ensuring the integrity and quality of laboratory and chromatographic data and reports. The position requires strong review experience and focuses on compliance with analytical methods and Good Manufacturing Practices.

Responsibilities

• Ensures the quality of laboratory data and reports
• Reviews chromatographic data, related notebooks and sample results for scientific soundness, completeness, accurate representation of the data, and final reported results
• Evaluates data to ensure compliance with analytical methods, client criteria, Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)
• Delivers review findings noting deficiencies within the analytical data or reports in a clear and concise manner
• Communicates with laboratory staff to proactively address the quality of laboratory documentation
• Prepares QC statements noting deficiencies with the analytical data set or notebooks
• Reports deficiencies to the project leader for correction
• Facilitates in conversations with lab staff on best documentation practices and addressing quality findings
• Advocates for quality and review process changes
• Identifies and supports process improvement initiatives

Skills

Degrees

Work schedule

Relocation