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:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

The Quality Assurance representative provides support to Indianapolis API Operations manufacturing and ensures quality systems and GMP compliance. The QA representative provides assistance and guidance in deviation investigations, change control proposals, procedure and master production record revisions, validations and batch dispositions. The QA representative's position is essential for maintaining quality systems, ensuring GMP compliance and in the preparation for inspections by various regulatory agencies.

Responsibilities:

Provide Process & Equipment Support

• Provide direct quality oversight of Indianapolis API production
• Provide quality guidance and recommendations to manufacturing, materials, utilities, and maintenance issues
• Provide technical support to non-routine (e.g., deviation) investigations including root cause analysis, countermeasure development, and implementation of actions
• Identify systemic issues affecting production (deviations, cycle time delays, etc.)
• Participate in the APR process.

Process Optimization & Continuous Improvement

• Review, identify and drive alignment of QA systems across Indianapolis API
• Support development and technical analysis for large-scale initiatives (secondary loop projects) such as productivity improvements, capacity development, GMP remediation, and safety risk mitigation
• Review and identify opportunities for continuous improvement and assist in prioritization of opportunities with respect to overall business objectives
• Work within cross-functional teams in a positive fashion to implement QA objectives and deliver on business plan and quality objectives.

Adherence to QA/Business Systems

• Provide support to the QA organization for deviation reduction and backlog prevention initiatives
• Participate in and/or lead self inspection activities
• Participate in and/or support regulatory inspections and audits
• Maintain and improve quality systems
• Assist others in the interpretation of regulatory and corporate requirements

Basic Requirements:

• BS in Engineering or science-related field or equivalent experience.

Additional Preferences:

• Experience in TS/MS, Engineering, QC, QA is preferred
• Good knowledge of cGMP, external Regulations and Lilly Quality Systems requirements
• Knowledge of protein chemistry & process/cleaning validation.
• Experience leading root cause investigations
• Excellent technical writing skills
• Ability to function in a team environment as a leader and as a member of teams
• Ability to partner/network outside the Indianapolis API site and participate in inspection readiness/continuous improvement initiatives

Additional Information:

• The normal schedule for this position is Monday-Friday, 8 hours/day. However, emergency situations may require additional support beyond this normal schedule.
• Travel (domestic and international) may be required.
• No certifications required.
• Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.

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. If you would like to request an accommodation for medical or religious reasons, you may do so at [email protected].

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.

Lilly is an EEO/Affirmative Action Employer and 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.

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).