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 Positive 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