Associate Quality Specialist supports project for strengthening data integrity compliance for electronic logs and day to day QA activities in the Ballydine facility. The Quality Specialist participates as a core member of the Quality Systems CoE Team.
Role Purpose
Act as a QA representative within a cross-functional project team to support the design, introduction, and continuous improvement of electronic logbooks (eLogs) across Operations, Quality Control, and Warehouse/Logistics. Ensure alignment with ALCOA+ Data Integrity principles and global QMS requirements.
Key Responsibilities
· Act as a functional QA expert within cross-functional teams to support project introduction and Right First Time performance across Ballydine.
· Provide QA oversight and input into the design and implementation of eLogs, ensuring alignment with Data Integrity expectations and global QMS standards.
· Apply strong quality systems knowledge to ensure robust design, including identification of risks, root cause considerations, and appropriate controls.
· Partner with stakeholders across Operations, QC, and Warehouse/Logistics to ensure solutions are practical, compliant, and fit for purpose.
· Support process mapping and risk assessments to ensure appropriate system selection and data capture approaches.
· Drive continuous improvement initiatives, identifying recurring issues and implementing sustainable system/process improvements.
· Support or lead elements of change control, CAPA development, and deviation considerations related to the project implementation.
· Communicate effectively across stakeholders, escalating risks and supporting decision-making where required.
· Contribute to maintaining inspection readiness, ensuring solutions meet regulatory expectations and withstand audit scrutiny.
·
Experience & Skills
· 2-3 years' experience in a GMP-regulated environment (QA / QC / Operations / Supply Chain / Quality Systems or similar).
· Experience supporting project introduction or system implementation in a regulated setting.
· Strong working knowledge of Data Integrity and practical application of ALCOA+ principles.
· Demonstrated understanding of Quality Systems, including deviations, CAPA, and change control processes.
· Proven ability to work effectively in cross-functional teams and influence stakeholders.
· Strong communication, problem-solving, and decision-making skills.
Desirable
· Experience with electronic logbooks or digital systems in manufacturing, laboratory, or warehousing environments.
· Knowledge of quality IT systems (e.g., SAP, Veeva, Kneat or similar).
· Experience supporting or participating in internal audits or inspection readiness activities.
· Exposure to lean / continuous improvement methodologies.
