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.
Organization 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.
Position Brand Description:
The QA Representative for the Chemical Dispensing team provides daily oversight, assistance, and guidance to issues such as non-conformance investigations, change control proposals, procedure / master formula revisions, validations, batch disposition, commissioning, and qualification activities. Advise and provide support for other floor support QA Representatives. The QA Representative 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 adhering to safety rules and maintaining a safe work environment for both yourself 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 systemsActive on local process team, as outlined in MSOE standard, or indirect participation through project support activitiesAbility to assess and triage deviations / observations that occur within the local process teamWork with Lilly support groups and external partners to resolve or provide advice on product related issuesParticipate in self-led inspections and provide support during internal / external regulatory inspectionsAbility 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 organizationSupport project and process improvement initiatives for Plant 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 assignmentBasic Requirements:
Bachelors Degree in a scientific field, or similar3+ years of manufacturing experience, floor support experience preferredAt least 1 year supporting quality
Additional Preferences:
Proven ability to work independently or as part of a team to resolve an issueStrong attention to detailExperience in GMP production environments or QCL is desirablePrevious experience with Deviation and Change Management processesProficiency with computer systems including Microsoft Office products, Regulus, TrackWise, PMX, and SAPDemonstrate strong oral and written communication and interpersonal skillsDemonstrated decision making and problem solving skillsDemonstrate technical writing and communication skillsOther Information:
May be required to respond to operational issues outside of core business hours/days.Applicant may work in various areas within the Parenteral Plant. 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 ExamLilly 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 - $140,800Full-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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