Sample interview questions: Can you describe your experience with analytical method development and validation?
Sample answer:
Analytical Method Development and Validation Experience:
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Method Development:
- Developed and optimized analytical methods for various matrices, including pharmaceutical products, food, and environmental samples.
- Utilized advanced techniques such as HPLC, GC-MS, LC-MS/MS, and ICP-OES to achieve specific analytical requirements.
- Optimized parameters including sample preparation, extraction, chromatography, and detection to enhance accuracy, precision, and sensitivity.
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Method Validation:
- Followed regulatory guidelines (e.g., ICH Q2(R1), USP, AOAC) to validate analytical methods for accuracy, precision, specificity, linearity, range, limit of detection (LOD), and limit of quantification (LOQ).
- Conducted comprehensive validation studies to demonstrate method performance and reliability.
- Generated validation reports summarizing data, statistical analysis, and method acceptance criteria.
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Troubleshooting and Optimization:
- Identified and resolved analytical method challenges related to matrix effects, interferences, and stability.
- Implemented modifications and improvements to enhance method robustness and specificity.
- Collabora… Read full answer
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