The QA Manufacturing Specialist, Senior is responsible for ensuring raw materials, products, processes, facilities, documentation, and systems conform to quality standards, internal procedures, systems, and governmental regulations.
Requirements
- Bachelor's degree in scientific field and 5 years experience
- MS/MA degree and 3 years’ experience in a QA GMP regulated environment within Biopharmaceuticals or equivalent
- US and EU cGMP guidelines/regulations
- Electronic document management systems, SAP and Microsoft Office suite
- Strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills
- Knowledge of biopharmaceutical manufacturing including cell culture, protein purification, and single-use platform technology