Quality (QA) Representative - Secondary Loop

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. We are looking for a "quality always" minded team member who works well cross functionally! This role is a secondary loop role, which means that you will provide support to the plant from a quality standpoint on projects, initiatives, escalations, etc. This role also provides support to the primary loop individuals from a quality technical standpoint, but does not have direct reports. Some off hour support may be needed, but is more limited compared to a primary loop role. Key attributes needed for this role are proactiveness, initiative, quality mindset, cross functional partnership, ability to influence, and technical aptitude. Position Brand Description: The mission of Quality Assurance is to provide independent oversight for manufacturing operations to ensure all products and materials meet quality requirements for their intended use and that quality systems are created, monitored, and maintained. The Secondary Loop QA Rep in Parenteral Manufacturing is a key member in a cross-functional team who provides assistance and guidance to Floor Support staff to achieve the reliable and compliant manufacture of parenteral drug product. The Secondary Loop QA Rep position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval / General Inspections by various regulatory agencies. Organization Overview: The Indianapolis Parenteral Manufacturing organization is located in Indianapolis, IN and provides various parenteral products for patients around the world. The mission of Quality Assurance is to provide independent oversight for manufacturing operations to ensure all products and materials meet quality requirements for their intended use and that quality systems are created, monitored, and maintained. The Secondary Loop QA Rep in Parenteral Manufacturing is a key member that can work effectively cross-functionally, is engaged, proactive, and provides support and guidance to Floor Support staff to achieve the reliable and compliant manufacture of parenteral drug product. The Secondary Loop QA Rep position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval / General Inspections by various regulatory agencies. Key Objectives / Deliverables: * Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals. * Lead, mentor, and coach operations and support personnel on quality matters. * Ensure regular presence in operational areas to monitor GMP programs and quality systems. * Interact with process teams by representing the Quality function to support improvement and productivity objectives including development and implementation of process improvement, including capital expansions and technical projects. Some projects will be given from supervision, but others should be identified/completed based on quality initiatives identified by the team member in the role. * Ability to assess and triage deviations / observations that occur within the local process teams. As well as other quality system management activities. * 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. * Work within cross-functional teams in a positive fashion to implement quality objectives and deliver on business plan and site objectives. * Lead and support project and process improvement initiatives for Plant Process Teams as representative of the Quality function. * Author, review, or approve documents, including control strategies, investigations, change controls, validations, qualifications, procedures, technical studies, etc. to ensure quality attributes are met and compliance with quality standards. * Network with Global Parenteral Network sites as resources and benchmarking sources Minimum Requirements: * Proficiency with computer systems including Microsoft Office products. * Good written and oral communication and interpersonal skills. * Knowledge and understanding of manufacturing process and Quality Systems. * Strong technical writing skills. * Ability to work independently or as part of a team to resolve an issue. * Strong decision making and problem - solving skills. * Strong attention to detail. Additional Preferences: * Demonstrated relevant experience in a GMP facility. * Knowledge of parenteral manufacturing and aseptic manufacturing practices. * Proficiency with local computer systems including QualityDocs, PMX, SAP, EWM, and LMS. Education Requirements: * Minimum of Bachelor's Degree required in scientific disciplines of Engineering, Biochemistry, Protein Chemistry, Biophysical Chemistry, Bioanalytical Chemistry, Microbiology, or Analytical Chemistry (or equivalent work experience). Other Information: * Day Shift, possible off - shift support. * This position will be in Indianapolis, but could require some travel, less than 10%, including international. * Tasks require entering manufacturing areas which require wearing appropriate PPE. * This position is tech ladder approved. 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 (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 - $162,800 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. #WeAreLilly

Created: 2025-09-27