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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

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.

Job Description: 

Support complaint handling and associated activities for devices, drug/device combination products and Connected Care products as needed.

Key Objectives / Deliverables:

·       Support timely completion of product complaint investigations, in compliance with global and local procedures

·       Assess incoming complaints and determine next steps needed to adequately address the complaint issue(s) in a timely manner

·       Determine the appropriate level of return sample analysis needed

·       Perform visual and/or functional analysis as needed

·       Complete all training for multiple devices

·       Verify and close relevant complaints with minimal supervision

·       Perform acceptance, safety query, and 20-day reporting duties as assigned

·       Support inventory management of complaint samples

·       Support QA personnel in writing GMP documents, and completing complaint process metrics, including second person verification (SPV) of complaints data

·       Ensure all complaints are appropriately and accurately documented in the Quality Management System (QMS)

·       Escalate significant issues to management as necessary

·       Utilize SMART LAB for the execution of the Non-Method Procedures (NMPs)

·       Support Complaint Lab’s 5S and Daily Management System (DMS) tasks as needed

·       Complete all project work and special assignments as applicable

·       Support continuous product and process improvements

Education Requirements: 

High school diploma or GED required, with some post-secondary education or Associates degree preferred.

Minimum Requirements:

·       Strong computer literacy in all Microsoft Office applications

·       Strong attention to detail

·       High degrees of self-management and problem solving

Additional preferences:

·       Knowledge of regulatory requirements (e. g. cGMP, 21 CFR 820, ISO 13485, Canadian MDR)

·       Knowledge of complaint handling and quality systems; device/combination product complaint experience preferred

·       Veeva QualityDocs experience

Other Information: 

Must be able to handle return complaint samples requiring execution of universal precautions and medical surveillance panel.

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 (https://careers.lilly.com/us/en/workplace-accommodation) 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.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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