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.

Position Brand Description:

The Representative - QA - IAPI provides support to Indianapolis API Operations manufacturing and laboratories and ensures quality systems and GMP compliance. The QA Representative provides assistance and guidance in deviation investigations, change control proposals, procedure and master production 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.

Key Objectives/Deliverables:

• Provide direct quality oversight of production, warehouse/material management, engineering, automation and laboratory operations.
• Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods and computerized system validations.
• Provide quality guidance and recommendations with regard to manufacturing, materials, utilities, maintenance and laboratory issues.
• Participate in aberrant data investigations.
• Conduct analytical data review including stability data.
• Disposition API Intermediates and raw materials, as appropriate.
• Provide coaching, feedback and mentoring to QA Specialists as it relates to execution of quality systems.
• Investigate customer complaints.
• Participate in and/or support recalls, as appropriate.
• Contribute to and review Annual Product Reviews (APR), Quarterly Product and Process Self-Assessments (QPPA), laboratory periodic reviews and equipment/computer system periodic reviews, as appropriate.
• Conduct gap assessments of global requirements and ensure implementation of the governing standards.
• 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 a science-related field or equivalent experience.

Additional Preferences:

• Experience with computer system validation.
• Demonstrated strong written and verbal communications skills.
• Strong attention to detail.
• Proficiency with computer system applications.
• Knowledge of cGMPs and quality systems.
• Understanding of statistical tools and analysis.
• Excellent interpersonal skills and networking skills.
• Ability to organize and prioritize multiple tasks.
• Previous experience in QA, QC, Manufacturing, Engineering, Tech Services or Regulatory Affairs.

Education Requirements:

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

Other Information:

• Must complete Learning Plan for Representative - QA - IAPI.
• No certifications required.
• Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.
• Must support 24 hour/day operations.

The job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. As always, you should consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

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).

#WeAreLilly