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:
The QA Representative will report to the Associate Director Quality (Materials). The Quality Assurance Representative for the Warehouse provides assistance and guidance to incoming material technicians and will advise on issues such as non-conformance investigations, change control proposals, procedures, commissioning, and qualification activities, with a focus on Warehouse operations. This person will also support activities within Warehouse operations, including goods receipt, sampling, and outbound shipping process as well as perform incoming inspections including ID testing, sampling of raw materials/GMP supplies (components, printed packaging materials, etc.) utilizing SAP and LIMS. Persons must be able to lift items up to 50 pounds.
Responsibilities:
- Practices safety behaviors with proper PPE and lifting techniques. Supports all HSE Corporate and Site Goals.
- Documenting inspections in accordance with procedures and specifications.
- Lead, mentor, and coach operations and support personnel on quality matters.
- 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.
- Participate in self-led inspections and provide support during internal / external regulatory inspections
- Ensuring materials not meeting specifications are quarantined, per local procedures.
- Evaluating damaged materials found on inbound shipments or within the warehouse and determine acceptability.
- Evaluating temperature excursions on shipments received at the warehouse.
- Identifies and assists in resolving issues on 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.)
- Initiates complaints/remarks to supplier for materials not meeting Lilly expectations.
- May participate in investigations regarding materials or service complaints.
- Authors/revises SOPs, materials specifications, as needed.
- Interacts with other functions and supports material related Supplier Change Notifications.
- Participates in/supports regulatory inspections, as needed.
Requirements:
- BA/BS degree in the sciences required.
- Must be able to lift up to 50 lbs.
- Position is 8 hour days - Monday through Friday
- Ability to work overtime, as required.
- Demonstrated understanding of cGMP regulations related to QA Warehouse and 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
- Previous facility or area start up experience.
- Previous experience in GMP production and warehouse environments.
- Understanding of statistical tools and analysis.
- Experience in inventory management systems (EWM, SAP, etc.)
- Experience using Trackwise
Additional Information:
- Ability to work 8 hour days - Monday through Friday.
- Ability to work overtime as required.
- This role will be permanently located at the Salisbury NC Warehouse with a 6 month temporary assignment for training purposes at the Concord Lilly site.
- This role will have training assignments at the RTP (Durham, NC) facility.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.