Analytical Sciences GMP Data Reviewer

The Analytical Chemistry Data Reviewer is responsible for reviewing GMP laboratory data and documentation to ensure compliance with established procedures, data integrity standards, and regulatory requirements. This role requires a strong chemistry background and experience reviewing analytical data in a GMP-regulated environment.

Key Responsibilities

GMP Data & Documentation Review

• Review GMP data generated by laboratory personnel to ensure compliance with approved procedures
• Verify logbook and documentation entries for accuracy, completeness, and adherence to GDP standards
• Confirm the sample chain of custody throughout the testing lifecycle
• Review audit trails to ensure actions align with procedural requirements and timelines

Cross-Training & Laboratory Support:

• May be required to participate in cross-training opportunities across laboratory testing functions to broaden technical knowledge and enhance operational flexibility.
• Develop and maintain proficiency in applicable analytical testing techniques and laboratory processes as assigned.
• May be required to provide occasional hands-on laboratory testing support during periods of increased workload, staffing needs, or business priorities, when qualified and appropriately trained.
• Collaborate with laboratory personnel to ensure timely completion of testing activities while maintaining compliance with GMP, GDP, safety, and regulatory requirements.

Communication & Issue Resolution

• Collaborate with testing personnel to resolve data annotations, discrepancies, or corrections
• Partner with laboratory teams to support compliance and continuous improvement initiatives

Good Documentation Practices (GDP)

• Accurately document activities in logbooks, notebooks, and electronic systems following GDP expectations

Safety & Compliance

• Conduct laboratory safety and compliance walkthroughs and document observations as required
• Complete all required safety, procedural, and refresher trainings on schedule