Representative - QA

2 weeks ago

Indianapolis, Indiana, United States Eli Lilly and Company Full time

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 Process Team member 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.

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 STEM discipline (science or engineering related preferred)Demonstrate 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 skillsAdditional 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 Lilly Event and Change Management processesProficiency with computer systems including Microsoft Office products, Regulus, TrackWise, PMX, and SAPAdditional Information:Overtime may be required. May be required to respond to operational issues outside of core business hours/days.Work in various areas in Parenteral Plant. Some allergens are present. Mobility and potential exposure to allergens should be considered when applyingPosition is located on site in Indianapolis at the Lilly Technology Center – South.Position is day shift, minimal travel required. Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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. #WeAreLilly

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