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Process Development Associate
Mastech DigitalSan Diego, CA, United Statesjob_description.job_card.variable_days_ago
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job_description.job_card.job_descriptionMaintains 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. Bachelor’s degree (sciences) 1+ years’ experience preferred Basic knowledge of QMS (Quality Management System) / GMP requirements
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.
Qualifications
Education
Experience
Skills
Must follow all applicable FDA regulations and ISO requirements.
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Development Associate • San Diego, CA, United States
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