KBI: US - QA Specialist II

Job Summary The Manufacturing Quality Assurance (MQA) Specialist supports the manufacturing process within a rapidly expanding GMP contract manufacturing organization. The specialist provides real‑time guidance to manufacturing, collaborates with cross‑functional teams, and ensures adherence to quality, risk, and regulatory requirements. Responsibilities Support manufacturing with real‑time compliance review of batch records, logbooks, and internal records. Lead deviation determination, generate guidance, and facilitate resolution. Perform routine core MQA activities, including batch record review, logbook approval, and SOP review. Conduct routine facility walkthroughs, track observations, and recommend corrective actions. Represent quality in interdepartmental meetings and support client comment resolution. Collaborate with manufacturing, laboratory, and other GMP functions to enable timely batch release. Qualifications High school diploma or equivalent; degree progression preferred. 1–3 years of GMP/regulated industry or laboratory experience. Ability to work effectively in team environments and understand manufacturing processes. Strong communication and interdepartmental meeting representation skills. Experience reviewing written procedures for accuracy and providing feedback. Associate degree/Bachelor’s degree strongly preferred for MQA Specialist II (4–6 years experience). Expect demonstrated ability to represent quality and become qualified trainers. Salary & Shift Pattern Salary range: $55,000–$86,900. MQA Specialist shifts: 12‑hour duration (0700–1900 or 1900–0700) on a 2, 2, 3 schedule to provide 24/7 site coverage. EEO Statement KBI Biopharma, Inc. is an EEO/AA employer committed to workforce diversity. All qualified applicants are encouraged to apply. KBI Biopharma encourages applicants of all backgrounds to apply. #J-18808-Ljbffr KBI Biopharma, Inc.