17 Aug
|
Genista Biosciences
|
Salem
17 Aug
Genista Biosciences
Salem
Position Summary
We are seeking an experienced Scientific Reviewer/Senior Scientific Reviewer (Analytical Chemistry) to support analytical laboratory operations through technical review, data verification, instrument troubleshooting, and quality investigations. The ideal candidate will possess a strong background in analytical chemistry and mass spectrometry and be capable of independently evaluating analytical data, conducting laboratory investigations, and ensuring compliance with quality system requirements.
Key Responsibilities
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
Qualifications
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
Solid 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 system
📌 Scientific reviewer (Salem)
🏢 Genista Biosciences
📍 Salem