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