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. Position Description: 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 building a new state of the art Parenteral, Device Assembly, and Packaging Facility in Concord, North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The Lilly Concord warehouse is a fully automated warehouse system with automated pallet conveyors, pallet exchangers, ASRS (Automated storage and retrieval system), and AGV (Autonomous Guided Vehicle) delivery of materials to the line. The Quality Assurance Representative for the Warehouse team provides daily oversight, assistance, and guidance to issues such as non-conformance investigations, change control proposals, procedures / master formula revisions, validations, batch disposition, commissioning, and qualification activities, with a focus on Automated Warehouse operations. This role reports directly to the Associate Director - Materials Quality. The Quality Assurance Representative position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval/General Inspections by various regulatory agencies. Key Objectives/Deliverables:
- Responsible for adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting HSE corporate and site goals.
- Lead, mentor, and coach operations and support personnel on quality matters.
- Ensure regular presence in warehousing areas, while also supporting device assembly and packaging areas, to monitor GMP programs, and quality systems.
- Active on local process teams with focus on Warehousing operations or indirect participation through project support activities.
- Ability to assess and triage deviations / observations that occur within the warehouse area.
- Work with Lilly support groups and external partners to resolve or provide advice on receiving or shipping issues.
- Approve commissioning qualification / validation documents for computer systems and equipment related to the warehousing operations, to ensure compliance with quality standards.
- Participate in self-led inspections and provide support during internal / external regulatory inspections.
- Effectively review and / or redline to ensure quality attributes are met. (i.e, deviations / observations, procedures, technical studies, validation protocols, change controls, and engineering documents).
- Participate in Six Sigma Projects to help improve productivity within the local process team or quality organization.
- Support project and process improvement initiatives for Plant Process Teams as representative of the Quality function, with focus on the warehousing processes (e.g., receiving, shipping, incoming material inspection).
Requirements (Education, Experience, Training): - Experience in GMP facility.
- Computer Systems Quality (CSQA) experience
Education Requirements: - Bachelor's degree, (preference in science, engineering, computer, or pharmaceutical related field of study).
Preferred attributes but not required: - Demonstrate strong oral and written communication and interpersonal skills.
- Demonstrated decision making and problem-solving skills.
- Demonstrate knowledge and understanding of manufacturing process and Quality Systems.
- Proficiency with computer systems including Microsoft office products, inventory management systems, and deviation management systems (i.e., SAP, Trackwise, etc.)
- Strong attention to detail.
- Proven ability to work independently or as part of a team to resolve issues.
- Previous experience in warehousing operations.
- Previous experience with ASRS warehousing, Autonomous Guided Vehicles, and integrated systems.
- Previous work with combination products or devices with experience with US/EU regulations and notified bodies.
- CQE, or CQA certification from the American Society for Quality (ASQ)
- Previous facility or area start up experience.
Additional Information: - May be required to respond to operational issues outside of core business hours / days.
- Applicant may work in various areas within the facility. Mobility requirements should be considered when applying for this position.
- Ability to work 12 Hour Rotating Shifts (Not Eligible for Remote Work)
- Ability to work overtime as required.
- Ability to travel up to 10% for meetings and training required
This 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 supervisor regarding your actual job responsibilities and any related duties that may be required for the position. 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 ( for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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. #WeAreLilly