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Senior Associate
1 month ago
We are a global healthcare leader that unites caring with discovery to make life better for people around the world. Our employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
Job Description
We are seeking a highly motivated and detail-oriented QA Sr. Associate to join our quality assurance team and ensure the highest standards of product quality and compliance for our computer systems.
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 (current Good Manufacturing Practices) and other relevant regulations.
- Collaborate with automation, IT, and production teams to ensure quality throughout the manufacturing process.
- Investigate and address deviations, non-conformities, and CAPA (Corrective and Preventive Actions) to maintain quality.
- Participate in IT and process automation organizations to provide consistency across all computer systems areas.
Key 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.
What We Offer:
We are dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.