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Senior Associate
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Senior Associate - Quality Assurance (MES), LimerickClient: Lilly
Location: Limerick, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: ea7f9147ee9a
Job Views: 4
Posted: 16.06.2025
Expiry Date: 31.07.2025
Job Description:We're looking for people who are determined to make life better for people around the world.
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing, and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
About Us: Eli Lilly Limerick is a cutting-edge biotechnology company dedicated to revolutionizing the healthcare industry through the development and production of next-generation biopharmaceuticals. Our state-of-the-art manufacturing facility employs the latest bioprocessing technologies to create life-saving therapies. We are seeking a highly motivated and detail-oriented QA Sr. Associate to join our quality assurance team and ensure the highest standards of product quality and compliance for our electronic batch records and associated Manufacturing Execution Systems (MES).
Position Summary: As a Manufacturing Execution System (MES) Quality Sr. Associate, you will play a critical role in maintaining the quality and regulatory compliance of our biopharmaceutical products within our next-generation manufacturing facility. You will work closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives.
Key Responsibilities:
- Develop and maintain quality assurance procedures, policies, and systems.
- Conduct routine self-inspections and monitoring assessments (time-on-the-floor) to ensure compliance with cGMP and other relevant regulations.
- Collaborate with automation, IT, and production teams to ensure quality throughout the manufacturing process.
- Investigate and address deviations, non-conformities, and CAPA to maintain quality associated with MES quality events.
- Participate in IT, production, and process automation organizations to provide consistency across all manufacturing execution systems.
Additional responsibilities include staying current with industry regulations, assisting in regulatory inspections, maintaining accurate documentation, and supporting quality improvement initiatives. The role requires a Bachelor's degree in Science, Engineering, Quality, or related discipline, with at least 3 years of QA experience in biotech, pharma, or medical device manufacturing. Knowledge of cGMP, FDA, Data Integrity, and Quality Risk Management is essential. Experience with systems like TrackWise and automation tools like DCS or DeltaV is a plus.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.
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