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Process Development Associate
Process Development AssociateMastech Digital • San Diego, CA, US
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Process Development Associate

Process Development Associate

Mastech Digital • San Diego, CA, US
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Job Summary

  • Primarily responsible for commercial manufacturing. Also responsible for the transfer of manufacturing processes from R&D to Manufacturing and continuous improvement of existing processes.

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

  • Maintains the Pilot Plant laboratory under cGMP conditions.
  • Produces development, pilot, and production materials per written instructions.
  • Completes ERP transactions
  • Stocks and maintains the laboratory supplies.
  • Keeps accurate records and documentation.
  • Completes laboratory work and associated paperwork by assigned completion dates.
  • Produces notebook materials per written instructions.
  • Develops manufacturing processes for transfer to Manufacturing.
  • Assists with execution of process validation of new and existing manufacturing processes.
  • Improves manufacturing processes.
  • Completes cycle counts
  • Washes lab ware.
  • Qualifications

    Education

  • Bachelor's degree (sciences)
  • Experience

  • 1+ years' experience preferred
  • Skills

    Basic knowledge of QMS (Quality Management System) / GMP requirements

    Must follow all applicable FDA regulations and ISO requirements.

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    Development Associate • San Diego, CA, US

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