Floor Representative – QA in Indianapolis

Job Description

Join American pharmaceutical leader Eli Lilly and Company, currently hiring Floor Representative – QA in Indianapolis, Apply Lilly careers in Indianapolis Indiana.

 

Position : Floor Representative – QA

Location : Indianapolis, Indiana

Job id: R-33705

 

Job Details

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 35,000 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.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.The QA Representative for the Floor Support 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 supports and/or drives issue resolution and process improvements as a content expert technical resource. In addition, the QA representative for the floor support provides monthly metrics, operational coaching, and process improvements within team. The QA-Representative must be capable of functioning as back up to other Plant Inspection Floor Support personnel.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)Support 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 Qualifications:Bachelor’s Degree in STEM discipline, Science or Engineering preferredAdditional Skills/Preferences:Working knowledge and proven application of cGMPs (e.g. relevant experience in GMP facility)Demonstrate technical writing and communication skillsDemonstrated ability to understand, interpret data and adjust actions (flexibility)Demonstrated decision making and problem-solving skillsDemonstrated proficiency with computer systems and multiple software applications including Microsoft Office products, Regulus, Trackwise, PMX and SAP.Demonstrated excellence in teamwork (Team Lilly framework) and interpersonal skillsPrevious experience in Inspection preferred.Experience in visual inspection, parenteral or packaging operationsProven ability to work independently or as part of a team to resolve issueStrong attention to detailExperience in Lean operations leveraging a Daily Management System (e.g. visual management, KPI, daily huddles, six sigma)Additional Information:Position supports a 24/7 operation and is expected to be flexible in maintaining availability for support in decision making and issue resolution as necessary to support operations of the facility.Overtime may be required. May be required to respond to operational issues outside of core business hours/days.Applicant will 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.Position is day shift, minimal travel required.#WeAreLillyEli 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 ( Lilly_Recruiting_Compliance@lists.lilly.com ) 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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

 

 

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