At Eli Lilly and Company, we are a global healthcare leader dedicated to making life better for people around the world. Our employees work together to discover and develop innovative medicines that address some of the world's most pressing health needs.
We are seeking a highly motivated and detail-oriented Senior Associate, Quality Assurance to join our quality assurance team. In this role, you will play a critical part in maintaining the highest standards of product quality and regulatory compliance within our biopharmaceutical manufacturing facility.
Key Responsibilities:
* Develop and maintain quality assurance procedures, policies, and systems.
* Conduct routine self-inspections and monitoring assessments to ensure compliance with current Good Manufacturing Practices (cGMP) and other relevant regulations.
* Collaborate with cross-functional teams to implement and uphold quality assurance standards.
* Investigate and address deviations, non-conformities, and Corrective and Preventive Actions (CAPA) to maintain quality.
Requirements:
* BSc, Hons BSc, MSc, or PhD in Science, Engineering, Quality, or related discipline.
* 3+ 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.