Sr. Associate

We’re looking for people who are determined to make life better for people around the world.

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 seekingmultiplehighly motivated and detail-oriented QA Sr. Associates to join our quality assurance team and ensure the highest standards of product quality and compliance in our facilities, maintenance, and utilities operational areas.

Position Summary: As a Facilities, Maintenance, Utilities QA 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:

1. Quality Assurance Oversight:

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 (current Good Manufacturing Practices) and other relevant regulations. Collaborate with utilities, maintenance, facilities, and QC teams to ensure quality throughout the manufacturing process. Investigate and address deviations, non-conformities, and CAPA (Corrective and Preventive Actions) to maintain product quality.

2. 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.

3. Documentation and Reporting:

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.

4. Quality Improvement Initiatives:

Identify areas for process improvement and work collaboratively with cross-functional process teams to implement changes. Participate in risk assessments and quality improvement projects.

5. Training and Development:

Provide training to staff 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 Science, Engineering, Quality, or related discipline.

Additional requirements:

2+years of experience in quality assurance within a biotechnology, pharmaceutical, or medical device 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.  Demonstrated initiative – able to work proactively without direct supervision and with a continuous improvement mind-set. Experience with quality management systems (e.g., TrackWise, Maximo, Kneat) 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.

#WeAreLilly

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