Quality Assurance Analyst

Role & responsibilities

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 Good 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