Lilly QA Leader - Warehouse in United States
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.
Position Brand Description:
Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina. The QA Leader –Warehouse is responsible for providing leadership to the Quality – Warehouse team, consisting of an Incoming Material Inspection team and QA Warehouse Support team. This position reports directly to the Quality Manager – Device Assembly & Packaging (DAP) and Warehouse. The QA Leader - Warehouse will oversee the Warehouse operations, including goods receipt, sampling, non-analytical incoming inspections/testing, and outbound shipping processes.
Practices safety behaviors with proper PPE and lifting techniques. Supports all HSE Corporate and Site Goals.
Manage the QA - Warehouse team, consisting of 2-6 Quality Specialists.
Responsible for training and managing the QA -Warehouse team in:
Performing incoming inspections (raw materials, components, printed packaging materials, etc.) according to priority.
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 (Darwin, SmartLab, etc).
When sampling a portion of the batch, ensure proper sampling plan is followed.
Performing ID testing of materials utilizing Raman or NIR Spectroscopy.
Maintaining retains and samples per local procedures.
Communicate with QA Disposition team to ensure materials are released in a timely manner, as to not delay production.
Evaluating damaged materials found on inbound shipments or within the warehouse and determine acceptability.
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.)
Provides additional Quality support to warehouse, as necessary.
May need to assist with performing department activities to ensure materials are available for production.
Responsible for ensuring team is trained and training remains in compliance.
Communicates with Quality Manager and Quality Representatives on quality issues.
Lead, mentor, and coach QA - Warehouse team, Operations, 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.
Initiates complaints/remarks to supplier for materials not meeting Lilly expectations.
May participate in investigations regarding materials or service complaints.
Networks with the business and ensures all materials are dispositioned in a timely manner to support production schedule.
Authors/revises SOPs, materials specifications, as needed.
Interacts with other quality functions and supports material related Supplier Change Notification's (SCN).
Participates in/supports regulatory inspections, as needed.
- BA/BS degree (sciences, engineering or supply chain preferred).
Previous materials or warehouse experience.
Previous experience leading and managing a team.
Demonstrated understanding of cGMP regulations related to QA Inspection applications.
Strong attention to detail.
Proficient in computer system applications.
Ability to organize and prioritize multiple tasks, highly flexible and able to work independently in fast paced environment to support production demands.
Excellent interpersonal and networking skills.
Highly motivated, enthusiastic, share ideas and lead solutions effectively to resolution; ensure safety of others.
Understanding of statistical tools and analysis.
Experience in inventory management systems (SAP, etc.)
Previous experience in GMP production environments.
Previous facility or area start up experience.
The position is for the Lilly Research Triangle Park site and during the project phase will allow for a flexible working environment with the ability to periodically work remotely based on the project phase and site activities.
Position may require a short duration assignment of 1-3 months in Indianapolis to establish specific device knowledge and establish global contacts.
Ability to work 8 hour days – Monday through Friday.
Ability to work overtime as required.
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. If you would like to request an accommodation for medical or religious reasons, you may do so at email@example.com.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!