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Technical Data Reviewer

Company: Atlas
Location: Rocky Mount
Posted on: January 24, 2023

Job Description:

Job Title: Technical Data Reviewer
Job Location: Rocky Mount - NC
Job Duration: 06 Months of Contract for Our Fortune 100 Client
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Job Description


  • The CQ Technical Data Reviewer reviews data from physical and dimensional testing of commodities, wet chemical techniques and instrumental analysis.
  • Included in this review are visual evaluations, titrations, pH measurements, AA, HPLC, GC and UV/Vis among other analysis.
  • In addition to data review, this individual could be responsible for preparing solutions, performing analysis, as well as recording and processing data in accordance with DEA, FDA, and ICH guidelines, as needed.

    Responsibilities


    • Functions as a dedicated data reviewer for the Chemical Quality Lab.
    • Prioritizes data review and testing with guidance from Data Coordinator or supervisor.
    • Assists in monitoring laboratory metrics associated with turnaround goals.
    • As needed, prepares solutions required for testing, performs analysis, records data according to cGMPs, performs calculations and enters results into LIMS system.
    • Provides support to assure lab safety and compliance -either through safe use of chemicals and/or the recognition of DEA, FDA, OSHA, and ICH compliance issues.

      Required Experience


      • Bachelor of Science in Life Science (e.g., Chemistry, Biology, Microbiology, etc.)
      • Minimum of 5 years of experience in a Quality Control or R&D laboratory and experience with a wide variety of analytical techniques (e.g., HPLC, GC, AA, UV-VIS, etc.) and biological techniques (e.g., BET, antibiotic potency, sterility, etc.).
      • Knowledge of cGMPs and regulations outside of the US.
      • Good communication, organization and computer skills are required.
      • Knowledge of LIMS, Empower, and Microsoft Office programs is desired.
      • Minimum of 1 year data review experience with minimum 5 yrs Lab Experience in pharmaceutical manufacturing environment.
      • Minimum of 4-5 years of experience reading and interpreting chromatographic data.
      • ICP-MS Experience Preferred

        Required Skills


        • HPLC basic experience (AA/ICP-MS)
        • Empower3 Experience
        • Chromatography Knowledge
        • cGMP
        • HPLC
        • GC
        • AA/ICP-MS
        • Data Review

          Education


          • Bachelor of Science in Life Science (e.g. Chemistry, Biology, Microbiology, etc.)

Keywords: Atlas, Rocky Mount , Technical Data Reviewer, IT / Software / Systems , Rocky Mount, North Carolina

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