Lead Technician - Quality Assurance, 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.

Organization Overview

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

Responsibilities

Make quality culture the foundation of your work, to ensure our products are delivered on time and in safe and effective manner to improve patients’ lives.

Support the business and operations by:

• Timely and accurate disposition of shipments for release to markets
• Quality support for international, domestic, and for third party logistics warehouse (3PL) 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; Make decisions to impact timely completion of documentation (deviations, product complaints, distribution complaints, CARTS)
• Read and interpret wireless temperature monitor data for shipments
• Review/write procedures
• Collaborate with other functions, including hands-on work and shared learning experiences
• Collect complaint details and initiate complaint records
• Author and investigate minor deviations and CAPAs
• Lead team projects with quality and business functions, specifically to drive process improvements
• Ensure area is in a state of inspection readiness; Support local, global and regulatory inspections
• Ensure Data Integrity and Good Documentation Practices while performing job tasks
• Provide updates to management regarding the quality performance within areas of support; Maintain metrics and quality reporting
• Maintain GMP Library documentation
• Engage in safety programs
• Other duties as assigned

Basic Requirements

• Associates degree or equivalent; High school graduate with pharmaceutical experience
• At least two (2) years working in pharmaceutical manufacturing and distribution and/or experience working with affiliate quality systems and/or clinical trial distribution process

Additional Skills/Preferences

• SAP experience strongly preferred
• Proven learning agility
• Ability to be flexible working in a warehouse environment; Must be able perform light lifting and wear warehouse-associated PPE
• Skills include ability to prioritize, work independently, written and oral communication, interpersonal,cross-functional collaboration, fundamental knowledge of computer applications, and problem solving.
• Experience working with cold chain processes
• Experience providing Quality quality operations support
• Experience with Lean methodology and systems approach
• Pr