Senior QA Specialist, Facilities & Compliance

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

Job summary

KBI Biopharma, Inc. is seeking a Senior QA Specialist to provide QA oversight for GMP facilities, validation, cleaning validation, and related GMP activities supporting clinical and commercial manufacturing.

The role collaborates with Engineering, Facilities, Validation, Manufacturing, MSAT, IT, and other teams to ensure systems and processes remain compliant and in control throughout their lifecycle.

Qualifications

• Bachelor’s or Master’s degree with extensive QA exposure in a cGMP biopharmaceutical setting.
• Experience reviewing/approving change controls, deviations, investigations, and CAPAs.
• Knowledge of US/EU cGMP regulations and guidelines required.

Responsibilities

• Provide QA oversight for GMP facilities, utilities, equipment, validation, cleaning validation, metrology, and computerized systems.
• Review and approve GMP documentation including qualification/validation protocols and reports, risk assessments, CAPAs, deviations, and change controls.
• Oversee commissioning, qualification, validation activities (IQ/OQ/PQ, process validation, cleaning validation, computerized system validation).
• Support cleaning validation strategies, risk assessments, sampling plans, acceptance criteria, and lifecycle management.
• Assess qualification/validation impact for new products, tech transfers, facility/equipment/process changes, and client onboarding.
• Ensure change controls include proper qualification, validation, and GMP requirements.

Skills

QA Oversight

cGMP

Cross-functional collaboration

Regulatory knowledge

Process validation

Risk-based thinking

Education

Bachelor’s degree with 8+ years in QA

Master’s degree with 5+ years in QA

Job description

KBI Biopharma, Inc. is seeking a Senior QA Specialist to provide QA oversight for GMP facilities, validation, cleaning validation, and related GMP activities supporting clinical and commercial manufacturing.

The role collaborates with Engineering, Facilities, Validation, Manufacturing, MSAT, IT, and other teams to ensure systems and processes remain compliant and in control throughout their lifecycle.