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

$63,000 - $162,800

Organization 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 39,000 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. Indianapolis Parenteral Manufacturing manufactures multiple parenteral drug products for our patients around the world.

Position Description:

The QA Representative provides daily oversight, assistance, and guidance to the Insulin Plant and supports issues such as non-conformance investigations, change control proposals, procedure / master formula revisions, validations, batch disposition, commissioning, and qualification activities. The QA Representative position is essential for maintaining GMP compliance and providing support to Parenteral Manufacturing.

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 goalsLead, mentor, and coach operations and support personnel on quality mattersEnsure regular presence in operational areas to monitor GMP programs and quality systems including various production activities such as drug product formulation, equipment preparation and aseptic filling activity.Lead triage to assess deviations that occur within process teamsPrepare metrics for process teams and represent QA at daily huddlesParticipate in self-led inspections and provide support during internal or external inspectionsAbility to effectively review and / or redline documents to ensure quality attributes are met (i.e., deviations, procedures, technical studies, validation protocols, change controls, and engineering documents)Participate in Lean OpEx Projects to help improve productivity within the local process teams and quality organizationSupport project and process improvement initiatives for process teams as representative of the Quality functionApprove commissioning qualification / validation documents for computer systems and equipment to ensure compliance with quality standardsNetwork with Global Parenteral Network sites as resources and benchmarking sources as applicable flexibility within job assignment

Additional Preferences:

Ability to work independently or as part of a team to resolve issuesStrong attention to detail and ability to make decisions in support of quality and compliance within the manufacturing environmentExperience in GMP production environments is desirable (operations, QA)Proficiency with computer systems including Microsoft Office products, Veeva, TrackWise, PMX, and SAPDemonstrate strong oral and written communication and interpersonal skillsDemonstrated decision making and problem-solving skillsDemonstrate knowledge and understanding of manufacturing process and Quality SystemsDemonstrate technical writing and communication skillsExperience with CAPA implementation and root cause investigations

Education Requirements:

Bachelor's Degree or equivalent (Science or Engineering related degree preferred).

Other Information:

This is a 12-hour day shift role on a 3-2-2-3 rotating scheduleOvertime may be required.May be required to respond to operational issues outside of core business hours / days.Applicant may work in various areas within the Parenteral Plants.  Some allergens are present in the Parenteral Plant.  Mobility requirements and exposure to allergens should be considered when applying for this position.May be subject to Post Offer Exam

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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