Senior QA Specialist, GMP Manufacturing

KBI Biopharma, Inc.; Durham (NC); On-site; USD 60,000 - 85,000; Full time

Job summary

KBI Biopharma, Inc. is seeking an MQA Specialist to support manufacturing operations on the GMP floor, ensuring real-time guidance and audit readiness. The role emphasizes collaboration with the manufacturing team, coaching, and contributing to GMP-compliant site initiatives.

The specialist will perform core tasks across batch record and logbook reviews, deviations triage, SOP reviews, and routine facility assessments to maintain quality and regulatory readiness on a fast-paced production line.

Qualifications

• High School diploma or equivalent required; degree progression preferred.
• Experience in GMP / regulated industry / laboratory environment is required (1–3 years).
• Ability to work effectively in a team and understand manufacturing processes.

Responsibilities

• Execute batch record review and approval.
• Review logbooks for accuracy and approval.
• Provide guidance on deviation triage and generation.

Skills

GMP knowledge

Quality systems

Deviations handling

Documentation review

Education

High School diploma

Associate/Bachelor's degree preferred

Job description

KBI Biopharma, Inc. is seeking an MQA Specialist to support manufacturing operations on the GMP floor, ensuring real-time guidance and audit readiness. The role emphasizes collaboration with the manufacturing team, coaching, and contributing to GMP-compliant site initiatives.

The specialist will perform core tasks across batch record and logbook reviews, deviations triage, SOP reviews, and routine facility assessments to maintain quality and regulatory readiness on a fast-paced production line.