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Job Title: Senior Associate - Stability Quality Assurance
Location: Raheen, Limerick, Ireland (Full-time on site)
Company: Eli Lilly & Company
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 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 & reference standards program, our microbiological and analytical laboratories and ensure the highest standards of product quality and compliance.
Position Summary: 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.
Key Responsibilities: Quality Assurance Oversight: Develop and maintain quality assurance procedures, policies, and systems.
Oversee the stability & 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).
Support stability studies and collaborate across departments to ensure product integrity and shelf-life requirements are met.
Act as a subject matter expert (SME) in stability & reference standard quality assurance and support audits and regulatory inspections.
Ensure proper storage, sampling, and testing of stability & reference standard samples, under defined conditions (e.g., accelerated, long-term, and stress studies).
Coordinate sample collection, labeling, storage, and testing timelines with appropriate stakeholders.
Coordinate cross-functional teams to manage stability study timelines and deliverables.
Oversee the stability study lifecycle, including protocol development, execution, and data analysis.
Oversee stability data trending, statistical analysis, and interpretation to assess product degradation and predict shelf-life.
Identify and communicate stability trends, deviations, or out-of-specification results to QA leadership.
Support investigations and corrective/preventive actions (CAPAs) related to stability issues.
Conduct routine self-inspections and monitoring assessments to ensure compliance with cGMP and other relevant regulations.
Collaborate with QC analytical teams to ensure product quality throughout the manufacturing process.
Collaborate with QA analytical team to ensure compliance in microbiological & analytical laboratories.
Support & evaluate change controls.
Regulatory Compliance: Stay current with industry regulations, guidelines, and best practices.
Assist in the preparation and execution of regulatory inspections and audits.
Ensure that all products meet regulatory requirements, including documentation and reporting.
Documentation and Reporting: Maintain accurate and compliant documentation of all stability & reference standard activities in electronic systems.
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.
Quality Improvement Initiatives: Identify opportunities to enhance stability & reference testing processes and workflows.
Identify areas for process improvement and work collaboratively with cross-functional process teams to implement changes.
Participate in risk assessments and quality improvement projects.
Training and Development: Provide training to staff or cross-functional teams on quality-related procedures and best practices.
Stay informed about the latest developments in biotechnology and quality assurance.
Qualifications: BSc, Hons BSc, MSc, or PhD in Pharmacy, Science, Engineering, Quality, or related discipline.
Minimum of 3 years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environment.
Strong knowledge of ICH guidelines (Q1A-Q1E), FDA/EMA regulations, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements.
Proficiency in data analysis and statistical tools for stability trend evaluation (e.g., JMP, Minitab).
Excellent problem-solving and analytical skills.
Detail-oriented with a strong commitment to maintaining high-quality standards.
Effective communication and teamwork skills.
Demonstrated initiative – able to work proactively without direct supervision and with a continuous improvement mind-set.
Experience with quality management systems (e.g., TrackWise, one QMS), experience with LIMs systems, experience within or supporting analytical production, and experience in microbiological & analytical support functions are a plus.
Ability to work in a fast-paced, cross-functional environment.
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