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Senior Quality Assurance Specialist

Glenmark Pharmaceuticals USA
Monroe, NC Full Time
POSTED ON 3/22/2025
AVAILABLE BEFORE 4/17/2025

Company Overview

Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules. As a fast-growing and robust US generics business, we plan to move into the innovative market.

Job Description

  • Perform quality control analysis in compliance with cGMP standards prescribed by USFDA.
  • Maintain data integrity and compliance in the QC lab according to USFDA standards.
  • Perform instrument qualification and calibration in the QC lab under the guidance of CQA.
  • Execute procedures and systems for raw materials, packaging materials, finished products, and in-process testing in the QC lab.
  • Provide information and data for stability study evaluation and execution according to quality and regulatory requirements.
  • Complete testing on time and ensure compliance during analytical TT and AMV performed in the QC lab.

Required Skills and Qualifications

  • Bachelor's degree in Chemistry or Pharmaceutical Sciences.
  • 4 years of experience in pharmaceutical manufacturing facilities, preferably in Quality Control.
  • Background in Stability, Finished Goods, and Raw Materials with some experience in Analytical R&D.
  • Extensive knowledge of general laboratory equipment, including GC, HPLC, Polarography, Particulate Matter, UV-Vis, and FTIR.

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