Principal Quality Associate Incoming Materials - Tank Farm/Solvent Recovery

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:

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.

Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN.  This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products.  This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations. 

Job Description:

To provide support to the Lebanon API Manufacturing Plant (LP1) materials management systems. The Materials Management (warehouse and tank farm) representative provides Quality Oversight for the inbound and outbound materials activities at the LP1 Site. This position supports all Materials Management activities relative to LP1 Inbound Products to ensure appropriate Quality Oversight.

The Materials Management (Warehouse) QA will provide assistance and guidance concerning incoming QA, warehouse QA, and incoming material disposition. This role reports directly to the Associate Director – Quality.  The Materials Management (Warehouse) QA position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval/General Inspections by various regulatory agencies as well.   

Responsibilities:

• Practices safety behaviors with proper PPE and lifting techniques. Supports all HSE Corporate and Site Goals.
• Participate in activities to involve QA Incoming, QA Warehouse/Tank Farm, and QA Incoming Batch Disposition.
• Responsible for Tank Farm/ Solvent Recovery activities as it relates to QA
• Support QA incoming functions at multiple warehouse locations and tank farm/solvent recovery.
• Responsible for:
  • Performing incoming inspections (raw materials, components, printed packaging materials, etc.) according to priority.
  • Evaluate and oversee timely release of incoming bulk solvent for Tank Farm and recovered solvent(s) from Tank Farm/Solvent Recovery unit(s).
  • Working experience in tank farm receipt and release of materials
  • Documenting inspections in accordance with procedures and specifications.
  • Ensuring materials not meeting specifications are quarantined, per local procedures.
  • Sampling, inspecting, and documenting results utilizing electronic systems (LIMS, etc).
  • Working with the QC Lab to deliver samples and receive results
  • Performing ID testing of materials utilizing Raman or NIR Spectroscopy. 
  • Maintaining retains and samples per local procedures.
  • Evaluating damaged materials found on inbound shipments or within the warehouse and determine acceptability.  
  • Ensuring storage condition is tracked, accurate, adjusted (as needed) including evaluating temperature excursions on shipments received at the warehouse.
  • Assists in resolving issues on inbound shipments (i.e. incorrect quantity or product, contamination, etc.).
  •  Performs appropriate transactions in SAP to ensure system represents appropriate status of material (QI, blocked, scrapped, etc.)
  • Disposition of incoming raw materials
  • Provide Quality support to warehouse with regard to deviations and other non-conformance issues
• Responsible for ensuring training remains in compliance.
• Communicates with QA Associate Director Materials and other cross functional peers on quality issues.
• Mentor and coach warehouse and support personnel on quality matters, while supporting and driving the site Quality culture.
• Ensure regular presence in operational areas to monitor GMP programs and quality systems.
• Work with materials management QA group to initiate complaints/remarks to supplier for materials not meeting Lilly expectations.
• May part