QA Specialist II, 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

Position Summary

The QA Specialist II provides Quality Assurance oversight and support for Facilities, Engineering, Validation, Cleaning Validation, Metrology, computerized systems, and related GMP activities supporting clinical and commercial manufacturing operations.

This position partners with Engineering, Facilities, Validation, Manufacturing, MSAT, IT, and other cross-functional teams to provide science- and risk-based Quality oversight and ensure facilities, utilities, equipment, systems, and validated processes remain compliant and in a state of control throughout their lifecycle.

Key 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.

Qualifications

• Bachelor’s degree with 5 years of relevant experience, or Master’s degree with 3 years of relevant experience, in a QA role within a cGMP-regulated biopharmaceutical or equivalent 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.

Preferred Skills

• Experience supporting cleaning validation, including protocols/reports, risk assessments, sampling strategies, deviations, and lifecycle activities.
• Strong technical judgment, problem-solving, and risk-based decision-making skills.
• Strong technical writing, communication, and cross-functional collaboration skills.
• Ability to independently manage multiple priorities and provide pragmatic, risk-based Quality guidance in a fast-paced manufacturing environment.

EEO/AA statement

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.