QA Specialist II, 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

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 escalated 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.

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.

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.

At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them.

We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills.

At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.

If you do not see a position that matches your background, we invite you to return to our site often as positions are updated frequently.