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 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.

Responsibilities

The Quality Assurance Floor Support Team assures patients worldwide of safe and efficacious drug products, through effective quality oversight of Indianapolis Parenteral Operations activities.

The QA Floor Support Lead Technician (Night Shift) is responsible for providing daily support and oversight to GMP operations at Indianapolis Parenteral Manufacturing. The QA Floor Support Lead Technician works as a team member supporting multiple production functions, from operations to maintenance, to achieve site goals while providing Quality oversight and guidance.

Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.Provides daily presence in operational areas to:Monitor GMP programs and quality systems and ensure adherence and understanding of good documentation practices and compliance with applicable procedures for both Operations and Support personnelMonitors for, retrieves, and completes review of all paperwork in need of quality review in each area supported and coordinates delivery to the associated area when complete.Review and approve GMP documentation in support of daily operations such as:Maintenance Action PlansReturn to Service and Release of equipment, product, and area HOLDsCycle Summary Reports for equipmentTicket Check - InWork Order assessments and issue resolutionRelease of Sanitization Agents and pH AdjustersOther documents as required.Provide guidance and assistance in identifying potential product quality impact and assessing if Observations are required.Performs observational requirements for Aseptic Process Simulation 14-Day Reads and supporting observation during formulation and fill related aseptic activities.Provide QA systems support to reconcile issues in multiple systems such as:LMSPMXTrackWiseEDMSGMARSAnd other systems as required.Work within QA Lead Technician team to ensure all manufacturing areas receive QA support needed to maintain daily operations.Reviews GMP documents (e.g., Procedures, Protocols, and Production Record Instructions).

Basic Requirements

High School Diploma or equivalentExperience working in a GMP facilityExperience with computer systems including Microsoft Office products, LMS, Darwin, TrackWise, Veeva Vault, and PMX.Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role.

Additional Preferences

Demonstrated relevant experience in a GMP facilityDemonstrated strong interpersonal skills and the ability to work as a teamDemonstrated organization skillsDemonstrated ability to learn quickly and utilize new skillsProficiency with computer systems including Microsoft Office products, LMS, Darwin, TrackWise, Veeva Vault, and PMX.Night Shift schedule flexibility.3+ years of parenteral manufacturing experienceStrong oral and written communication and interpersonal skillsStrong attention to detailExperience in Production QA, QC is desirableExperience with TrackWise/Veeva OneQMS Deviation and Change Management processes.

Other Information

Applicant may work in various areas within the Parenteral Plant.  Some allergens are present in the Parenteral Manufacturing plant.  Mobility requirements and exposure to allergens should be considered when applying for this positionMaintain qualifications and certifications for access to all supported areas required of the position, including but not limited to aseptic gowning certificationMay be subject to Post Offer ExamMandatory overtime may be required, planned and unplanned

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

$28.84 - $46.54

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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