Senior Quality Assurance Associate

Quality Assurance Associate

This is an exciting opportunity to join our quality assurance team as a Quality Assurance Associate. In this role, you will play a critical part in ensuring the highest standards of product quality and compliance for our electronic systems.

You will be responsible for developing, designing, maintaining the quality and regulatory compliance of our biopharmaceutical products within our next-generation manufacturing facility.

This is a hands-on and strategic role at the intersection of quality, digitalization, and laboratory operations — ideal for someone who thrives in dynamic environments.

You will work closely with cross-functional teams to implement and develop quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives.

1. Quality Assurance Design and Oversight: Implement Global Quality Standards to the new Lilly Limerick site.
2. Provide quality direction and governance for QA-owned e-systems, site IT systems, and site laboratory systems.
3. Develop and maintain quality assurance procedures, policies, and systems.
4. Conduct routine self-inspections and monitoring assessments (time-on-the-floor) to ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulations.
5. Investigate and address deviations, non-conformities, and CAPA (Corrective and Preventive Actions) to maintain quality.
6. Review and approve change controls related to GxP systems and lab equipment, ensuring appropriate impact and risk assessments.
7. Apply ICH Q9 principles to qualify and mitigate risks in system-related changes or deviations Participate in IT and quality organizations to provide consistency across all computer systems areas.
8. Evaluate events related to data loss, system outages, or unauthorized access from a quality and compliance perspective.
9. Perform and support data flow mapping for production, analytical, and site-wide processes.
10. Partner with Digital/IT, QC, TSMS and Engineering teams to ensure GxP compliance of all laboratory e-systems and analytical technologies.
11. Ensure compliance with CSV and data integrity principles, including ALCOA+ and 21 CFR Part 11.
12. Regulatory Compliance: Stay current with industry regulations, guidelines, and best practices.
13. Assist in the preparation and execution of regulatory inspections and audits.
14. Ensure compliance with periodic review, change control, deviation, back up and archive, security, and other support processes for IT systems.
15. Participate in quality meetings keeping the group updated on initiatives within the QA owned GMP IT systems.
16. Conduct or oversee data integrity assessments across systems and equipment and contribute to audit readiness for QA owned systems, QC systems and Process analytical technology systems.
17. Assess compliance with 21 CFR Part 11 / EU Annex 11 for electronic records, electronic signatures, audit trails, user access, and backup/restore functions.
18. Review audit trail reviews, non-terminal record reviews, exception reports, and integrity control mechanisms.
19. Ensure GxP computerized systems undergo routine periodic reviews to assess validation status, user access, audit trail review, and backup testing.
20. Ensure readiness of computerized systems and equipment documentation and provide defense of QA oversight activities.
21. Support CSV (Computerized System Validation) strategy and execution for GxP systems, ensuring fitness for intended use and regulatory compliance
22. Documentation and Reporting: Maintain accurate and comprehensive quality records, change control documentation, and quality reports.
23. Develop common local procedures for computer systems and help the site consistently interpret and implement global policies across all computer systems areas.
24. Develop or contribute to GxP procedures, templates, and guidance documents related to CSV, equipment qualification, data integrity, and system governance.
25. Review and approval of key GMP documents such as GMP standard operating procedures and CSV deliverables as appropriate to area of responsibility.
26. Review and approval of GMP documents associated with qualification and validation including IQ/OQ/PQ & validation documents for facilities, equipment, computer systems, GMP utilities and system periodic review reports as appropriate to area of responsibility.
27. Quality Improvement Initiatives: Identify areas for process improvement and work collaboratively with cross-functional process teams to implement changes.
28. Participate in risk assessments and quality improvement projects.
29. Drive risk-based decision-making and QA input into digital and automation initiatives.
30. Identify and implement QA best practices in support of a fully digital lab environment.
31. Provide independent QA oversight throughout the computerized system lifecycle: from planning, specification, qualification/validation, operation, to retirement/decommissioning
32. Training and Development: Provide training to staff on all relevant aspects of computer system quality.
33. Stay informed about the latest developments in computer systems validation and quality assurance.
34. Deliver training on CSV principles, data integrity, and regulatory expectations to internal teams.
35. Promote a culture of compliance and continuous improvement related to computerized systems and lab automation.