Process Development Associate
Job 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 associate paperwork by assigned completion dates.
- Produces notebook materials with written instructions.
- Develop manufacturing processes for transfer to Manufacturing.
- Assists with execution of process validation of new and existing manufacturing processes.
- Improve 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.
- 1+ years’ experience preferred
Education/Experience:
- Bachelor’s degree (sciences)
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