QC Analyst (Analytical Chemistry)

 Posted 2 hours ago
  
 India
  
⭐ 2-5 years experience
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AI Summary

The role involves reviewing analytical data from various mass spectrometry and chromatographic methods to ensure accuracy and compliance. It also requires conducting OOS/OOT investigations, performing root cause analysis, and troubleshooting analytical instrumentation.

QC Analyst (Analytical Chemistry)


Position Summary
We are seeking an experienced QC Analyst 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

  • 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

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