QA Specialist II – GMP Manufacturing & Process Quality

KBI Biopharma; North Carolina; On-site; USD 60,000 - 90,000; Full time

Job summary

KBI Biopharma, Inc. is seeking an MQA Specialist to support manufacturing operations at our North Carolina site in a GMP-compliant manner. The role involves real-time guidance on process and product SISPQ, and collaboration with Manufacturing to maintain inspection readiness.

Responsibilities include batch record review, logbook approval, deviation triage, routine facility walkthroughs, and SOP review, with potential coaching duties to uphold quality standards.

Qualifications

• GMP knowledge and experience in regulated environments.
• Ability to work in a team and across departments.
• Understanding of manufacturing processes and quality systems.
• Ability to review and provide feedback on written procedures.

Responsibilities

• Review and approve batch records.
• Review logbooks for accuracy and compliance.
• Provide deviation triage guidance.
• Perform routine facility walk-throughs and address cleanroom concerns.
• Respond to alarms and maintain GMP standards.
• Review SOPs for accuracy and updates.
• Reconcile bulk fill labeling and related documentation.
• Support external client reviews and resolution of comments.

Skills

GMP knowledge

Team collaboration

Understanding manufacturing process

Procedure review

Education

High School diploma or equivalent

Associate/Bachelor degree preferred

Job description

KBI Biopharma, Inc. is seeking an MQA Specialist to support manufacturing operations at our North Carolina site in a GMP-compliant manner. The role involves real-time guidance on process and product SISPQ, and collaboration with Manufacturing to maintain inspection readiness.

Responsibilities include batch record review, logbook approval, deviation triage, routine facility walkthroughs, and SOP review, with potential coaching duties to uphold quality standards.