QA Representative DAP

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 Quality Assurance Representative for the Device Assembly and Packaging team provides daily oversight, assistance, and guidance to issues such as non-conformance investigations, change control proposals, procedures revisions, validations, batch disposition, commissioning, and qualification activities. The Quality Assurance Representative position is essential for maintaining GMP compliance and providing support during preparation for General Inspections by various regulatory agencies. Key Objectives/Deliverables: Responsible for adhering to safety rules and maintaining a safe work environment for both you and others by supporting HSE corporate and site goals. Lead, mentor, and coach operations and support personnel on quality matters. Ensure regular presence in device assembly and packaging areas to monitor GMP programs, and quality systems. Active on local process teams or indirect participation through project support activities. Ability to assess and triage deviations / observations that occur within the device assembly and packaging areas. 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. 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 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. Requirements (Education, Experience, Training): Minimum 5 years experience in GMP facility. Bachelor’s degree Preferred attributes but not required: 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) CSQA experience Previous experience in GMP production environments. Previous facility or area start up experience. 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. Strong attention to detail Proficiency with computer systems including Microsoft office products, SAP, Veeva Quality Docs, etc. Proven ability to work independently or as part of a team to resolve issues.

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

$65,250 - $169,400

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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