Process Development AssociateMastech Digital • San Diego, CA, US

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Process Development Associate

Mastech Digital • San Diego, CA, US

4 days ago

Job type

Full-time

Job description

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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