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QA Specialist II

QA Specialist II

KBI BiopharmaDurham, NC, USA
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JOB SUMMARY

This position is responsible for the compliance review of Biopharmaceutical

Development GMP data. This includes the review and approval of release, in-

process, and stability test data. This position is also responsible for the review and

approval of method qualifications and validations. Another responsibility is the

review and approval of laboratory investigations and deviations associated with the

biopharmaceutical development department.

JOB RESPONSIBILITIES :

  • Performs compliance review on the following records : release, in-process, and stability data.
  • Responsible for the review and approval of method qualifications and validations
  • Responsible for the review and approval of deviations and laboratory investigations.

MINIMUM REQUIREMENTS :

  • BS and 11+ years experience or MS and 8+ years experience in a CGMP regulated

    • environment within biopharmaceuticals or equivalent.

  • Experience in QA review of analytical data (release, in-process, and stability), experience in reviewing method qualifications / validations and the review and approval of laboratory investigations and

    • deviations. Knowledge of USP, EU and JP cGMP guidelines.

  • Ability to read, analyze, and interpret general business periodicals, professional journals,

    • technical procedures, or governmental regulations.

  • Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
  • Ability to solve practical problems and deal with a variety of concrete variables in

    • situations where only limited standardization exists.

  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Basic math skills are required.
  • Ability to apply concepts of basic algebra and statistics.
  • Be able to sit for long periods of time.
  • Ability to lift 20 pounds.
  • Ability to use word processing, database, spreadsheets, power point, internet, e-mail, calendar, computer, telephone
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    Qa Specialist • Durham, NC, USA