Senior QA Specialist, GMP Facilities & Validation

KBI Biopharma, Inc.; Durham (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC seeks a QA Specialist II to provide quality assurance oversight across facilities, validation, cleaning validation, metrology, and computerized systems for clinical and commercial manufacturing.

The role partners with Engineering, Facilities, Validation, MSAT, IT, and other teams to ensure systems stay in a state of control. Responsibilities include reviewing GMP docs, supporting commissioning/qualification/validation activities, and driving risk-based

Qualifications

• Bachelor’s degree with 5 years of QA exp or Master’s with 3 years in cGMP biopharma.
• Experience providing QA oversight of commissioning, qualification, and validation activities.
• Experience reviewing change controls, deviations, investigations, and CAPAs.
• Knowledge of US/EU cGMP regulations.

Responsibilities

• Provide QA oversight for GMP facilities, utilities, equipment, and validated systems.
• Review and approve GMP documentation including qualifications/validation protocols and reports, risk assessments, deviations, CAPAs, change controls.
• Provide QA oversight of commissioning, qualification, and validation activities including IQ/OQ/PQ and computerized system validation.
• Review calibration and maintenance plans and certifications.
• Support cleaning validation strategies, protocols, reports, and lifecycle management.
• Assess qualification/validation impact of new products, technology transfers, and changes.
• Provide QA oversight of change controls and ensure GMP requirements are addressed.
• Support facility upgrades, capital projects, shutdowns, and manufacturing readiness.
• Review investigations and CAPAs related to facilities, utilities, equipment, validation, and systems.
• Support regulatory inspections and client/audit readiness.
• Identify and escalate quality/compliance risks, drive issue resolution with cross-functional teams.
• Support continuous improvement of quality, qualification, validation, and change control processes.

Skills

QA oversight

cGMP knowledge

Cross-functional collaboration

Regulatory knowledge

Technical writing

Education

Bachelor's degree in QA/biopharma or related

Master's degree in QA/biopharma or related

Job description

KBI Biopharma, Inc. in Durham, NC seeks a QA Specialist II to provide quality assurance oversight across facilities, validation, cleaning validation, metrology, and computerized systems for clinical and commercial manufacturing.

The role partners with Engineering, Facilities, Validation, MSAT, IT, and other teams to ensure systems stay in a state of control. Responsibilities include reviewing GMP docs, supporting commissioning/qualification/validation activities, and driving risk-based