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.

Company Overview:

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.

Organization Overview:
The Device Assembly Quality Assurance (QA) Representative for the Floor Support team member provides daily oversight, assistance, and guidance to issues such as non-conformance investigations, change control proposals, procedure and master formula revisions, validations, batch disposition, commissioning, and qualification activities for the assembly processes. The QA Representative also advises and provides support for other floor support QA Representatives. The QA Representative position is essential for maintaining GMP compliance and providing support during preparation for Inspections by various regulatory agencies.

Responsibilities:

Lead, mentor, and coach operations and support personnel on quality matters.Ensure regular presence in operational areas to monitor GMP programs and quality systems.Active on local process team, as outlined in internal standards, or indirect participation through project support activities.Ability to assess and triage deviations that occur within the local process team.Work with Lilly support groups and external partners to resolve or provide advice on product related issues.Participate in self-led inspections and provide support during internal / external regulatory inspections.Ability to effectively review and / or redline documents 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.Approve commissioning, qualification / validation documents for computer systems and equipment to ensure compliance with quality standards.Network with other device and packaging sites as resources and benchmarking sources as applicable flexibility within job assignment.

Basic Requirements:

Bachelor's Degree in STEMMinimum 1 year experience in a GMP facility.

Additional Skills/Preferences:

Proven ability to work independently or as part of a team to resolve an issue.Strong attention to detail.Experience in GMP production environments or QCL is desirable.Proficiency with computer systems including Microsoft Office products, Veeva, TrackWise, PMX, and SAP.Demonstrated strong oral and written communication and interpersonal skills.Demonstrated decision making and problem-solving skills.Demonstrated knowledge and understanding of manufacturing process and Quality Systems.Demonstrated technical writing and communication skills.Responsible for adhering to safety rules and maintaining a safe work environment for both you and others by supporting HSE corporate and site goals.

Additional Information:

May be required to respond to operational issues outside of core business hours / days.Applicant may work in various areas within the IDAP Plant. Some allergens are present in the IDAP Plant. Mobility requirements and exposure to allergens should be considered when applying for this position.Position is located at the Lilly Technology Center - South.

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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

$63,000 - $140,800

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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