QA Associate

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 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 give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Organization Overview:

Product Research and Development (PRD) Quality Assurance (QA) is responsible for providing quality oversight of all materials used in clinical trials. T

Responsibilities:

The Quality Assurance Associate provides quality and compliance support for API manufacturing within the Product Research and Development (PR&D) area. The Quality Assurance Associate provides day to day Quality oversight for products manufactured on site, at Collaboration Partners (CP) or intra-company partners for use in clinical trials. The responsibilities for this role include:

• Support API Manufacturing within PR&D, particularly as it relates to decisions associated with impact to the quality of products.
• Qualification and Quality oversight of API Collaboration Partner manufacturing.
• Perform pre- and post- review of batch production records utilized for manufacturing.
• Author, review, approve Change Controls and Deviation investigations. Assess the impact of change controls and events on the product and regulatory commitments.
• Ensure appropriate execution of Quality Systems to sustain compliance with regulatory requirements and good manufacturing practices.
• Support and / or evaluate the disposition of batches, including management and review of GMP documentation, analytical results and regulatory commitments.
• Ensure inspection readiness through compliance auditing, site self-assessments, GMP education, monitoring, establishing and enhancing Quality systems.
• Provide support for internal and regulatory site inspections.

Basic Requirements:

• Bachelor's degree in Science-related field or Engineering.
• Demonstrated minimum 1-year relevant experience in a cGMP facility.

Additional Skills/Preferences:

• Proficiency with applicable computer systems (e.g., Trackwise).
• Demonstrated strong oral and written communication skills.
• Demonstrated interpersonal skills and the ability to work as a team.
• Root cause analysis/troubleshooting skills.
• Demonstrated attention to detail and ability to maintain quality systems.
• Proven ability to work independently or as part of a team to resolve an issue.
• Previous experience in QA, QC, Operations, TS/MS, Engineering, or Regulatory is desirable.

Additional Information:

• This job is located in Indianapolis, IN. Work will primarily occur on site with some flexibility for occasional remote work within the US.
• Occasional travel may be required for collaboration partner oversight, training, conferences, etc.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [email protected] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

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