Analytical Quality Assurance (AQA)
- Perform analytical data review of raw data, worksheets, chromatograms, spectra, calculations, and analytical reports.
- Conduct soft copy data review in laboratory software systems such as Empower, OpenLab, Lab Solutions, LIMS, CDS, etc.
- Review electronic audit trails for compliance with data integrity and regulatory requirements.
- Verify adherence to ALCOA+ principles and Valuable Documentation Practices (GDP).
- Review analytical method execution and ensure compliance with approved procedures.
- Support laboratory investigations and ensure analytical records are complete, accurate, and traceable.
- Perform and coordinate investigations related to:
- Out of Specification (OOS)
- Out of Trend (OOT)
- Laboratory incidents
- Deviations