We're looking for people who are determined to make life better for people around the world.
About Eli Lilly Limerick: We're 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.
Job Description: As a Facilities, Maintenance, Utilities QA Associate, you'll play a critical role in maintaining the quality and regulatory compliance of our biopharmaceutical products within our next-generation manufacturing facility. You'll 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 utilities, maintenance, facilities, and QC teams to ensure quality throughout the manufacturing process.
* Investigate and address deviations, non-conformities, and CAPA to maintain product quality.
* Stay current with industry regulations, guidelines, and best practices.
* Assist in the preparation and execution of regulatory inspections and audits.
* 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 and process flow documents.
* Identify areas for process improvement and work collaboratively with cross-functional process teams to implement changes.
* Provide training to staff on quality-related procedures and best practices.
Qualifications:
* BSc, Hons BSc, MSc, or PhD in Science, Engineering, Quality, or related discipline.
* 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.
Additional 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.
Eli Lilly & Company is an equal employment opportunity employer. We prohibit discrimination based on age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.