Job Description

Please Note: This is a day shift opportunity that follows a 2-2-3 schedule

Job Summary

The QA Manufacturing Specialist is responsible for ensuring raw materials, products, processes, facilities, documentation, and systems conform to quality standards, internal procedures, systems, and governmental regulations.

This position will provide a broad range of quality oversight for activities that support bulk drug substance manufacturing. This position will be responsible for on the floor review of executed records (batch record section review, solution records, equipment records, and logbooks) supporting all aspects of cGMP operations. Client and regulatory audit/inspection support is also within job scope.

Job Responsibilities

  • Perform on-the-floor compliance review on executed records including batch records, equipment preparation records, and solution record and associated forms, in-process data, and logbooks.

  • Perfor...

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