Senior QA Specialist – GMP Facilities & Validation

NCBioImpact; Durham (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC seeks a QA Specialist II to provide Quality Assurance oversight for GMP facilities, utilities, equipment, engineering, validation, cleaning validation, metrology, and computerized systems throughout their lifecycle.

You will partner with cross-functional teams including Facilities, Engineering, Validation, Manufacturing, MSAT, IT, and Quality to ensure compliance and state of control, review critical documents, support audits, deviations, CAPAs, and lifecycle

Qualifications

• Bachelor’s degree with 5 years of relevant experience, or Master’s with 3 years in a QA role within a cGMP biopharma environment.
• Experience providing QA oversight of commissioning, qualification, and validation activities for GMP facilities, utilities, equipment, and computerized systems.
• Experience reviewing and approving change controls, deviations, investigations, and CAPAs.
• Knowledge of U.S. and EU cGMP regulations and guidelines is required.
• Experience supporting clinical and/or commercial biopharmaceutical manufacturing is preferred.
• Strong technical judgment, problem-solving, communication, and cross-functional collaboration skills.

Responsibilities

• Provide QA oversight for GMP facilities, utilities, equipment, Engineering, Validation, Cleaning Validation, Metrology, and computerized systems.
• Review and approve GMP documentation including qualification and validation protocols/reports, cleaning validation documentation, risk assessments, deviations, CAPAs, change controls, and return-to-service documentation.
• Provide QA oversight of commissioning, qualification, and validation activities, including facility/utility and equipment qualification, IQ/OQ/PQ, process validation, cleaning validation, and computerized system validation, as applicable.
• Review calibration and maintenance plans and certifications.
• Support cleaning validation activities including validation strategies, protocols/reports, risk assessments, sampling plans, acceptance criteria, worst-case assessments, hold-time studies, and lifecycle management.
• Assess qualification and validation impact associated with new products, technology transfers, facility/equipment/process changes, and new client onboarding.
• Provide QA oversight of change controls and ensure appropriate qualification, validation, cleaning validation, and GMP requirements are identified and addressed.
• Support facility upgrades, capital projects, shutdowns, equipment modifications, and commercial manufacturing readiness.
• Review and support investigations and CAPAs associated with facilities, utilities, equipment, validation, cleaning validation, maintenance, calibration, and computerized systems.
• Support regulatory inspections, client audits, internal audits, and inspection/PAI readiness activities.
• Identify and elevate Quality and compliance risks and partner with cross-functional teams to drive issues to resolution.
• Support continuous improvement of Quality, qualification, validation, and change control processes.

Skills

QA oversight

Cross-functional collaboration

Regulatory knowledge

Problem solving

Education

Bachelor’s degree in QA/related field

Master’s degree in QA/related field

Job description

KBI Biopharma, Inc. in Durham, NC seeks a QA Specialist II to provide Quality Assurance oversight for GMP facilities, utilities, equipment, engineering, validation, cleaning validation, metrology, and computerized systems throughout their lifecycle.

You will partner with cross-functional teams including Facilities, Engineering, Validation, Manufacturing, MSAT, IT, and Quality to ensure compliance and state of control, review critical documents, support audits, deviations, CAPAs, and lifecycle