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Process Development Associate

Process Development Associate

SGS ConsultingSan Diego, CA, United States
8 hours ago
Job type
  • Full-time
Job description

Summary : First Shift

Monday through Friday

Hours : 6 : 30am to 3 : 00pm

100% on-site

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

Responsibilities :

  • 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.

    • Skills :

  • Basic knowledge of QMS (Quality Management System) / GMP requirements
  • Must follow all applicable FDA regulations and ISO requirements.

    • Qualifications :

  • Bachelor’s degree (sciences)
  • Quality assurance / control background, non-science college major, and had R&D backgrounds. Previous manufacturing experience helps, but fresh grads with some other type of work experience okay too.
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    Development Associate • San Diego, CA, United States