Bio-manufacturing QA Shopfloor Support
Posted on: April 19, 2021
Industry: Biotech / Pharma
Job Number: JN -042021-62837
- 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.
- 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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