KBI: US - Principal QA Specialist
KBI BiopharmaDurham, North Carolina, United States
Posted May 8, 2026
113000 - 156000 USD
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
This individual is responsible for the compliance review of Biopharmaceutical GMP data and provides QA oversight of analytical and microbial laboratory activities.
Requirements
- Bachelor’s degree and 10+ years’ experience or Master’s degree and 6+ years’ experience in a QA, QC or cGMP environment in Biopharmaceuticals or equivalent
- Demonstrated strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills
- Strong understanding of FDA, EU and cGMP regulations is required
- Experience in Quality Control and Quality Systems is beneficial