Provide routine QA presence on the manufacturing floor during operations (about 50% of the role) to ensure GMP compliance and audit readiness
Perform GMP walkdowns and make independent quality decisions
Review and approve nonconformance investigations, track them to closure, and coordinate root cause analysis and corrective actions
Administer the change control system, including chairing the site change control board
Review and approve qualification and validation documentation
Administer the electronic NC/CAPA system, including user access, training, upgrades and reporting
Administer the electronic document management system and support document control for SOPs and GMP documents
Support internal and external audits and track corrective actions
Support GMP training development and deliver compliance training as a subject matter expert
Administer supplier approval, review incoming materials documentation and support raw material specifications
Review and approve batch records and release batches in SAP
Administer the SAP Quality Management module
Review and approve SOPs, work instructions, forms and validation plans from other departments
Deputize for the QA Team Lead as needed

Bachelor's degree in a scientific or technical discipline
3-5 years of experience in quality, manufacturing, validation or compliance in the biological and/or pharmaceutical industry
Knowledge of FDA, EMEA, HPRA and other regulations for biologics and pharmaceuticals, with the ability to apply GMP
Previous experience in a shift role desirable
Competencies: independent quality decision-making, visible shop-floor leadership, teamwork, communication, attention to detail, problem solving
Role is 100% on-site, 4-cycle shift

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Posted	22 Oct 2026
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QA Shift Specialist (R-105580)