QA Manufacturing Specialist II
KBI BiopharmaDurham, North Carolina, United States
Posted May 22, 2026
Full Time
About the Company
KBI Biopharma is an award-winning biopharmaceutical contract services organization providing fully-integrated, accelerated drug development and biomanufacturing services to pharmaceutical and biotechnology companies globally. With each of our 500+ client partners, we have worked closely to personalize and rapidly accelerate their drug development programs. Built upon a foundation of world-class analytical capabilities, we deliver efficient process development and clinical and commercial cGMP manufacturing services for mammalian and microbial programs. KBI is proud to be a JSR Life Sciences Company.
Job Description
The QA Manufacturing Specialist II is responsible for ensuring raw materials, products, processes, facilities, documentation, and systems conform to quality standards, internal procedures, systems, and governmental regulations.
Requirements
- BS/BA in scientific field and 5 years experience or MS/MA degree and 3 years’ experience in a QA GMP regulated environment within Biopharmaceuticals or equivalent
- Knowledge of US and EU cGMP guidelines/regulations is desired
- Experience with electronic document management systems, SAP and Microsoft Office suite are preferred
- Demonstrated 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 is preferred