Senior QA Specialist: Facilities & Compliance (GMP)

KBI Biopharma; Durham (NC); On-site; USD 100,000 - 150,000; Full time

Job summary

KBI Biopharma in Durham, NC seeks a Senior QA Specialist to provide QA oversight for facilities, engineering, validation, cleaning validation, metrology, and computerized systems supporting clinical and commercial manufacturing.

This role partners with Engineering, Facilities, Validation, Manufacturing, MSAT, IT, and other cross-functional teams to ensure facilities, utilities, equipment, systems and validated processes remain compliant and in control throughout their lifecycle.

Qualifications

• Bachelor’s or Master’s degree with relevant QA experience in a cGMP biopharmaceutical environment.
• Experience reviewing and approving change controls, deviations, investigations, and CAPAs.
• Knowledge of U.S. and EU cGMP regulations and guidelines.
• Experience supporting clinical and/or commercial biopharmaceutical manufacturing is preferred.
• Strong technical judgment, problem-solving, communication, and cross-functional collaboration skills.
• Ability to independently manage multiple priorities and provide risk-based Quality guidance.

Responsibilities

• Provide QA oversight for GMP facilities, utilities, equipment, engineering, validation and computerized systems.
• Review and approve GMP documentation including qualification/validation reports, CAPAs, change controls, and deviations.
• Oversee commissioning/qualification/validation activities (IQ/OQ/PQ, process validation, cleaning validation, computerized systems).
• Support cleaning validation strategies, plans, and lifecycle management.
• Assess qualification/validation impact of new products, tech transfers, and changes; onboard new clients.
• Oversee change controls to ensure proper qualification/validation and GMP compliance.

Skills

Technical judgment

Problem-solving

Communication

Cross-functional collaboration

Change controls experience

Regulatory knowledge

Education

Bachelor’s degree with 8+ years in QA

Master’s degree with 5+ years in QA

Job description

KBI Biopharma in Durham, NC seeks a Senior QA Specialist to provide QA oversight for facilities, engineering, validation, cleaning validation, metrology, and computerized systems supporting clinical and commercial manufacturing.

This role partners with Engineering, Facilities, Validation, Manufacturing, MSAT, IT, and other cross-functional teams to ensure facilities, utilities, equipment, systems and validated processes remain compliant and in control throughout their lifecycle.