Senior QA Specialist, Facilities & Compliance

KBI Biopharma•Durham, NC

About The Position

The Senior QA Specialist 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.

Requirements

Bachelor’s degree with 8+ years of relevant experience, or Master’s degree with 5+ years of relevant experience, in a QA role within a cGMP-regulated biopharmaceutical or equivalent environment.
Experience reviewing and approving change controls, deviations, investigations, and CAPAs.
Knowledge of U.S. and EU cGMP regulations and guidelines is required.
Strong technical judgment, problem-solving, 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.

Nice To Haves

Experience supporting clinical and/or commercial biopharmaceutical manufacturing is preferred.
Experience supporting cleaning validation, including protocols/reports, risk assessments, sampling strategies, deviations, and lifecycle activities.
Experience providing QA oversight of commissioning, qualification, and validation activities for GMP facilities, utilities, equipment, and computerized systems.
Strong technical judgment, problem-solving, and risk-based decision-making skills.
Strong technical writing, communication, and cross-functional collaboration skills.
Ability to independently manage priorities and provide pragmatic Quality solutions in a fast-paced cGMP environment.

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.
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 escalate 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.