Principal QA Specialist
KBI BiopharmaDurham, North Carolina, United States
Posted February 13, 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
Individual contributor and special project leader responsible for ensuring compliance with internal quality documents, regulatory requirements, and cGMP. The role will serve as Quality-to-Quality client liaison and sometimes SME for the Quality team reporting cross-QA metrics and status for KBI and clients.
Requirements
- BS/BA Degree in Science or Engineering relevant to the pharmaceutical / Life Science or related industries AS/AA acceptable with 7-10 years of relevant experience as described below.
- Minimum 5 years prior experience in the Pharmaceutical/Biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP Quality and Regulatory requirements.
- Minimum of 2 years of previous experience in QA and experience in a Client-Facing QA role.