KBI: US - Principal QA Specialist

Position Summary:

 This individual is responsible for the compliance review of Biopharmaceutical GMP data. This includes the review and approval of in-process, release, and stability test data. Provides QA oversight of analytical and microbial laboratory activities including but not limited to method qualification, method transfers, method validations, creation and revision of test methods, specifications, stability studies, laboratory investigations and laboratory deviations. The Principal QA Specialist provides exemplary service to both internal and external customers by ensuring patient safety and regulatory compliance while supporting product lifecycle activities for timely delivery of products to clients for patients. Collaborates with clients, laboratories, manufacturing, QA batch disposition and other internal stakeholders as needed to achieve site, operational and department specific goals. Cultivates and maintains Quality culture.

May perform as a team le...