Bio-manufacturing QA Shopfloor Support

Devens, Massachusetts
Industry: Biotech / Pharma
Job Number: JN -042021-62837

Description:

  • Provide Quality assistance and oversight to operations, for in-process intermediates and manufactured products, and other GMP processes as required. Performs review and approval of documentation associated with in-process materials, and manufactured product. Assists in the identification, generation and quality review of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.

 

Required:

  • Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred.
  • A minimum of 6-10years of relevant experience in a regulated environment with 2-4 years focused on product quality preferred
  • Demonstrated ability to independently assess complex manufacturing and automation issues
  • Knowledge of biotech cell culture, protein purification, bulk and finished product manufacturing is required
  • Knowledge of US and EU cGMP regulations and guidance.
  • Knowledge of manufacturing batch record execution and review, maintenance execution approval, inventory management, and deviation management and approval is desirable


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