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QC IPL Analyst

  • Lieu:

    Gand, Belgique

  • Contact:

    Dardo Helpers

  • Type de poste:

    Temp to Perm

  • Téléphone de contact:

    +32 15 44 58 52

  • Secteurs d’activité:

    Biotechnology

  • Contact E-mail:

    dardo_helpers@oxfordcorp.com

  • Responsible for the completion of QC testing related to the manufacturing of autologous CART products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
  • * Ensure testing is completed in compliance with all applicable procedures, standards and GMP regulations. * Work with Process Development team, Quality and Operations organization to successfully transfer process/analytical testing to cGMP facility to manufacture products.
  • Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories. * Perform peer review/approval of laboratory data.
  • Utilize electronic systems (LIMS) for execution and documentation of testing.
  • Create, review and approve relevant QC documents, SOP's and WI's.
  • Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
  • Other duties will be assigned, as necessar

Capabilities, Knowledge, and skills:

  • Experience in a Quality Control setting is preferred.
  • Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required.
  • Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.
  • Knowledge of Good Tissue Practices is required.
  • Excellent written and oral communication skill are required
  • Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as

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