Lead Technician - Quality Assurance (QA) Logistics Operations

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 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.

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.

Organization Overview:
This position reports to the Senior Manager, Quality Assurance - Logistics Operations and supports Eli Lilly product distribution within the United States as well as exports to international Lilly affiliates.

Responsibilities:

The Quality Assurance (QA) Logistics Operations Lead Technician is responsible for quality support for North America Logistics Operations (NALO) and for export operations to the international Lilly affiliates. The QA Logistics Operations Lead Technician works within the quality systems related to operations support for NALO and will serve as an expert for distribution release.  The QA Logistics Operations Lead Technician is also a point of contact between QA and Operations and is expected to make decisions regarding quality within the NALO Quality System.  This role includes quality oversight responsibilities related to distribution operations. The QA Logistics Operations Lead Technician is responsible for ensuring compliance with all Good Manufacturing Practices (GMPs), internal standards, systems, procedures, and guidelines for distribution activities.

This position reports to the site Sunday – Thursday between the hours of 11:00 AM – 8:15 PM.

Specific responsibilities include the following support to the distribution business functions:

• Timely and accurate disposition of products for release to markets
• Quality support for international and domestic shipping operations
• Presence on the warehouse floor to answer questions and provide assistance to operations
• Provide coaching and feedback to operational staff
• Apply technical expertise regarding distribution to make independent decisions
• Read and interpret temperature monitor data for shipments
• Collaborate with other functions, including hands-on work and shared learning experiences
• Lead team projects with quality and business functions, specifically to drive process improvements
• Review and write procedures
• Make decisions to impact timely completion of documentation (deviations, product complaints, distribution complaints)
• Ensure Data Integrity and Good Documentation Practices while performing job tasks
• Provide updates to management regarding the quality performance within areas of support
• Maintain GMP Library documentation
• Maintain metrics and quality reporting
• Support local, global, and regulatory inspections
• Engage in safety programs
• Participate in self-inspections
• Ensure area is in a state of inspection readiness

Basic Requirements:

• High School graduate or equivalent 
• Skills include ability to prioritize, work independently, written and oral communication, cross-functional collaboration, fundamental knowledge of computer applications, and problem solving
• Ability to be flexible working in a warehouse environment; Must be able perform light lifting and wear warehouse-associated PPE
• At least two (2) years working in pharmaceutical manufacturing and distribution and/or experience working with affiliate quality systems and/or clinical trials distribution

Additional Skills/Preferences:

• Experience working in distribution, packaging, and/or with cold chain processes
• Experience providing quality operations support 
• Experience in operations 
• Experience with Lean methodology and systems approach
• Proven ability to collaborate with globally diverse groups 

Additional Information:

• Travel: 5%
• Some overtime may be required 

Lilly is 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