Sr Analyst, Quality Control-1

Posted 16 Days Ago
Be an Early Applicant
Pudupakkam, Marakkanam, Viluppuram, Tamil Nadu
In-Office
Senior level
Healthtech • Pharmaceutical • Telehealth
The Role
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.
Summary Generated by Built In

Job Description Summary

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

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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The Company
Montreal, Quebec
1,722 Employees
Year Founded: 1997

What We Do

At Endo, our far-reaching vision is simple: to help everyone we serve live their best life. As a specialty pharmaceutical company, we’re motivated by a strong sense of purpose to find better ways to meet unique medical needs.

Our global team of passionate employees understands the importance of their work. We’re dedicated to supporting one another as we connect with communities and foster partnerships that elevate quality-of-life and bring the best treatments forward.

Our uncompromising commitment results in the delivery of life-enhancing therapies. From intelligent product selection to commercialization, we strive to make a meaningful, tangible impact to help everyone live their best life.

Endo has global headquarters in Malvern, Pennsylvania.

Community Guidelines:
1. Be respectful. Everyone who visits our page should feel comfortable and respected.
2. If we see a comment that violates anything in the following list, it may be removed.
• Comments that use profanity; personally attack or bully another individual; or are off-topic, misleading, factually inaccurate, political, spam, defamatory, discriminatory or promotional.
• Comments that are excessively repetitive and/or disruptive to the community.
• Comments that promote illegal activity, use copyrights or trademarks or are related to an ongoing legal matter.
• Comments that appear to be medical advice.
We reserve the right to remove a reply for any reason at any time.
3. Adverse Event Reporting: If we see a post about an adverse event, an Endo representative will need to contact you to find out more information to comply with regulatory guidelines. If you experience a side effect while using an Endo product, please consult your physician or pharmacist immediately. You may also report to the FDA at fda.gov/medwatch or 800-FDA-1088.

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