Sr. Associate - Stability Quality Assurance

<p>At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.</p><p></p><p><b>Job Title:</b> Senior Associate - Stability Quality Assurance</p><p><b>Location:</b> Raheen, Limerick, Ireland (Full-time on site)</p><p><b>Company:</b> Eli Lilly &amp; Company</p><p></p><p><b>About Us:</b> 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 is at the forefront of innovation, employing the latest bioprocessing technologies to create life-saving therapies. We are seeking a highly motivated and detail-oriented Stability QA Sr. Associate to join our Quality Assurance team supporting our stability &amp; reference standards program, our microbiological and analytical laboratories and ensure the highest standards of product quality and compliance.</p><p></p><p><b>Position Summary:</b> As a Stability QA 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.</p><p></p><p><b>Key Responsibilities:</b></p><p></p><p><span>1.  Quality</span> Assurance Oversight:</p><ul><li><p>Develop and maintain quality assurance procedures, policies, and systems.</p></li><li><p>Oversee the stability &amp; reference standards program and ensure compliance with global, regulatory and quality standards (e.g., ICH Q1A-Q1E, FDA, EMA, WHO) including Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).</p></li><li><p>Support actively stability studies and collaborate across departments to ensure product integrity and shelf-life requirements are met.</p></li><li><p>Act as a a subject matter expert (SME) in stability &amp; reference standard quality assurance and support audits and regulatory inspections.</p></li><li><p>Ensure proper storage, sampling, and testing of stability &amp; reference standard samples, under defined conditions (e.g., accelerated, long-term, and stress studies).</p></li><li><p>Coordinate sample collection, labeling, storage, and testing timelines with appropriate stakeholders.</p></li><li><p>Coordinate cross-functional teams to manage stability study timelines and deliverables.</p></li><li><p>Oversee the stability study lifecycle, including protocol development, execution, and data analysis.</p></li><li><p>Oversee stability data trending, statistical analysis, and interpretation to assess product degradation and predict shelf-life.</p></li><li><p>Identify and communicate stability trends, deviations, or out-of-specification results to QA leadership.</p></li><li><p>Support investigations and <span>corrective/preventive</span> actions (CAPAs) related to stability issues.</p></li><li><p>Conduct routine self-inspections and monitoring assessments (time-on-the-floor) to ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulations.</p></li><li><p>Collaborate with QC analytical teams to ensure product quality throughout the manufacturing process.</p></li><li><p>Collaborate with QA analytical team to ensure compliance in microbiological &amp; analytical laboratories.</p></li><li><p>Support &amp; evaluate change controls.</p></li></ul><p></p><p></p><p>2. Regulatory Compliance:</p><ul><li><p>Stay current with industry regulations, guidelines, and best practices.</p></li><li><p>Assist in the preparation and execution of regulatory inspections and audits.</p></li><li><p>Ensure that all products meet regulatory requirements, including documentation and reporting.</p></li></ul><p></p><p><span>3.  Documentation</span> and Reporting:</p><ul><li><p>Maintain accurate and compliant documentation of all stability &amp; reference standard activities in electronic systems.</p></li><li><p>Prepare and review documentation related to product quality and compliance including GMP standard operating procedures, process flow documents as well as equipment qualification and process validation documentation.</p></li></ul><p></p><p><span>4.  Quality</span> Improvement Initiatives:</p><ul><li><p>Identify opportunities to enhance stability &amp; reference testing processes and workflows.</p></li><li><p>Identify areas for process impro