Hikma Pharmaceuticals USA Inc.

  • Scientist I QC Aero Star, 2nd Shift

    Job Location US-OH-Columbus
    Posted Date 2 weeks ago(2 weeks ago)
    Job ID
    2018-4784
    Job Function
    Quality
    Shift
    2nd
  • Overview

    To perform routine, work-flow processes within the quality control laboratory to meet customer requirements by supporting the testing of raw materials and finished products while ensuring regulatory compliance standards and release times are met.

    Responsibilities

    • Perform qualitative, quantitative chemical and physical testing and as specified by compendia or specification for raw materials, packaging components and finished products and intermediates
    • Maintain laboratory data in an orderly manner in laboratory notebooks, worksheets and documents.
    • Perform peer review of analytical testing documentation.
    • Complete and/or conduct required training according to the laboratory and site curriculum.
    • Other Duties as assigned.

    Qualifications

    • BS in Chemistry or a science-related field. One or more years of pharmaceutical experience preferred.
    • Required: hands-on experience with the following, preferably in a GMP or industrial setting:
      • pH meters
      • Analytical Balances and scales
      • Computer applications (Microsoft Office – Excel, Word, PowerPoint)
      • Basic statistical inference (standard deviation, linear regression tools)
    • Required: ability to work independently using a team approach to accomplish tasks assigned; ability to work on multiple projects in a fast pace environment.

    • Required: good written and verbal communication skills.

    • Prior work related experiences or knowledge that are highly desirable include:

      • Validation, execution and transfer of analytical methods
      • Compendial testing of raw materials (APIs, excipients, package components)
      • Pharmaceutical products and intermediate testing. The individual must be able to perform compendial and non-compendial testing for multiple projects at one time.
      • Experience with Empower data analysis software.
      • cGMP, DEA, or other regulated environment
    • Hands-on experience with the following analytical techniques is highly desirable, in a scholastic or industrial setting. Individual will receive formal training in these techniques as appropriate to their specific role:

      • Chromatography: HPLC, GC, IC, uPLC
      • Spectroscopy: UV, UV/Vis, IR/FTIR, Raman, NIR, XRF, IonScan
      • Dissolution
      • Physical Tests: Particle Sizing, microscopy, DSC, TGA, XRD
      • Specialized pharmaceutical testing (Compendial Monograph or General Chapter, dissolution)
    • Working knowledge of the specified equipment and techniques to perform troubleshooting is highly desired.

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