The Senior Analyst in Quality Control leads analytical testing, develops and validates methods, and ensures compliance with GMP standards in the pharmaceutical and chemical industries.
Job Description Summary
Professional SummaryCandidate must have Experienced and detail-oriented Senior Analyst with over 10 years in Quality Control within the pharmaceutical and chemical industries.
Proven expertise in analytical instrumentation including HPLC, GC, and LCMS, method development and validation, and regulatory compliance. Adept at troubleshooting, data interpretation, and ensuring product quality in alignment with GMP standards.
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Core Competencies
• High-Performance Liquid Chromatography (HPLC)
• Gas Chromatography (GC)
• Liquid Chromatography–Mass Spectrometry (LCMS)
• Analytical Method Development & Validation
• Stability Studies & Impurity Profiling
• GMP, GLP & Regulatory Compliance
• Instrument Calibration & Maintenance
• Data Analysis & Documentation (LIMS, Empower, Chromeleon)
• Team Collaboration & Training
________________________________________
Professional Experience
Senior Analyst – Quality Control
Lead analytical testing using HPLC, GC, and LCMS for raw materials, intermediates, and finished products.
• Develop and validate analytical methods in compliance with ICH guidelines.
• Perform routine and non-routine analysis, stability studies, and impurity profiling.
• Maintain and calibrate analytical instruments ensuring minimal downtime.
• Prepare and review technical documents including SOPs, STPs, and validation protocols.
• Collaborate with cross-functional teams for investigations and CAPA implementation.
• Train junior analysts on instrument handling and analytical techniques.
• Conducted routine QC testing using HPLC and GC.
• Supported method transfer and troubleshooting activities.
• Ensured compliance with GMP and maintained accurate documentation.
• Participated in internal audits and regulatory inspections
Job Description
Professional Summary
Candidate must have Experienced and detail-oriented Senior Analyst with over 10 years in Quality Control within the pharmaceutical and chemical industries.
Proven expertise in analytical instrumentation including HPLC, GC, and LCMS, method development and validation, and regulatory compliance. Adept at troubleshooting, data interpretation, and ensuring product quality in alignment with GMP standards.
Core Competencies
- High-Performance Liquid Chromatography (HPLC)
- Gas Chromatography (GC)
- Liquid Chromatography–Mass Spectrometry (LCMS)
- Analytical Method Development & Validation
- Stability Studies & Impurity Profiling
- GMP, GLP & Regulatory Compliance
- Instrument Calibration & Maintenance
- Data Analysis & Documentation (LIMS, Empower, Chromeleon)
- Team Collaboration & Training
Professional Experience
Senior Analyst – Quality Control
Lead analytical testing using HPLC, GC, and LCMS for raw materials, intermediates, and finished products.
- Develop and validate analytical methods in compliance with ICH guidelines.
- Perform routine and non-routine analysis, stability studies, and impurity profiling.
- Maintain and calibrate analytical instruments ensuring minimal downtime.
- Prepare and review technical documents including SOPs, STPs, and validation protocols.
- Collaborate with cross-functional teams for investigations and CAPA implementation.
- Train junior analysts on instrument handling and analytical techniques.
- Conducted routine QC testing using HPLC and GC.
- Supported method transfer and troubleshooting activities.
- Ensured compliance with GMP and maintained accurate documentation.
- Participated in internal audits and regulatory inspections
Top Skills
Chromeleon
Empower
Gc
Hplc
Lcms
Lims
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