About this role
Role Overview
- Review analytical data generated from LC-MS/MS, GC-MS/MS, ICP-MS, HPLC, and GC methods for accuracy, completeness, and compliance.
- Perform and document Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations.
- Conduct root cause analysis and implement corrective and preventive actions (CAPA) as required.
- Evaluate quality control results, calibration data, system suitability, and method performance.
- Troubleshoot analytical instrumentation and analytical issues impacting data quality.
- Review and approve laboratory worksheets, calculations, chromatograms, spectra, and final reports.
- Assist with method validation, verification, and transfer.
- Ensure compliance with ISO 17025, GMP, GLP, and internal quality requirements.
- Investigate deviations and support laboratory quality assurance activities.
- Maintain accurate documentation and ensure data integrity requirements are met.
Requirements
- Master's with 4+ years of experience in an analytical testing laboratory post qualification or Ph.D. degree with 2+ years of experience post qualification
- Strong understanding of chromatographic and mass spectrometric techniques including: LC-MS/MS, GC-MS/MS, ICP-MS, HPLC/UHPLC, GC
- Working knowledge of ISO 17025, GMP, GLP, and laboratory quality systems
Benefits
- Fully Remote