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Senior QC Chemist - Pharma

Senior QC Chemist - Pharma

BioconCranbury, NJ, United States
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Job Purpose :

  • Perform routine testing and decides on the acceptability of the in-process, process validation samples, raw materials, packaging materials, finished products, stability samples and developmental samples in a regulated laboratory environment.
  • Analyze and interpret results in written and oral format.

Duties and Responsibilities

  • Perform routine tests of Raw materials, Packaging materials, In-process and Finished products and stability samples including wet chemistry analysis, dissolution, content uniformity, assay, particle size distribution, density, water determination by KF, and other tests according to the in-house monographs and USP using classical wet chemistry and instrumental (HPLC, GC, etc).
  • Evaluates test results and decides acceptability of the samples based on the test results.
  • Maintain accurate lab notebooks and complete all related analytical reports, write summaries, and keep proper documentation in compliance with SOPs.
  • Maintain the laboratories with good housekeeping practices and in compliant with cGMP.
  • Ensure notebooks are reviewed in a timely manner, in accordance with SOPs.
  • Writes or revise test procedures, protocols, SOPs, based on the outcome of the experimental design.
  • Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices
  • Educationand / or Experience :

  • Bachelor's degree in Chemistry or Pharmacy or related scientific field with minimum 4 to 8 years' experience in Pharmaceutical analysis or Master's degree in Chemistry or Pharmacy or related scientific field with minimum 4 to 8 years' experience in Pharmaceutical analysis.
  • Clear understanding of normal, molar and percent concentrations. Ability to prepare solutions according to a required concentration.
  • Ability to deal with problems involving several concrete variables in standardized situations.
  • Must have Valid work permit.

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