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.

• 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.

• 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 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.

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.