At Eli Lilly and Company, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader that gives our best effort to our work and puts people first.
About Us
We give back to our communities through philanthropy and volunteerism. 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 develop innovative solutions to tackle complex health challenges.
Our Team
We're looking for people who are determined to make life better for people around the world. If you share our passion for improving human health, we encourage you to join us on this journey.
Eli Lilly Limerick
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.
Key Responsibilities
As a Biotechnology 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.
Quality Assurance Oversight
You will be responsible for developing and maintaining quality assurance procedures, policies, and systems, conducting routine self-inspections and monitoring assessments (time-on-the-floor) to ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulations, collaborating with production and QC teams to ensure product quality throughout the manufacturing process, investigating and addressing deviations, non-conformities, and CAPA (Corrective and Preventive Actions) to maintain product quality.
Regulatory Compliance
You will stay current with industry regulations, guidelines, and best practices, assist in the preparation and execution of regulatory inspections and audits, and ensure that all products meet regulatory requirements, including documentation and reporting.
Documentation and Reporting
You will maintain accurate and comprehensive quality records, including batch records, change control documentation, and quality reports, 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, and perform batch disposition, including approval of drug substance batch records and associated CoA's.
Quality Improvement Initiatives
You will 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
You will provide training to staff on quality-related procedures and best practices, stay informed about the latest developments in biotechnology and quality assurance, and contribute to a culture of ongoing learning and professional development.
Qualifications
To be successful in this role, you will need a BSc Hons, MSc, or PhD in Pharmacy, Science, Engineering, Quality, or related discipline, with a minimum of 5 years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environment, strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements, excellent problem-solving and analytical skills, detail-oriented with a strong commitment to maintaining high-quality standards, effective communication and teamwork skills, and demonstrated initiative – able to work proactively without direct supervision and with a continuous improvement mind-set.