Scientist - QA

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.The QA Representative for manufacturing floor support within the Indianapolis Parenteral Manufacturing site 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 in support of making and releasing medicine to patients around the world. The QA Representative will be a member of a cross functional process team supporting manufacturing processes and will also 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.Responsibilities:Responsible for adhering to safety rules and maintaining a safe work environment for both you and others by supporting health, safety and environmental 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 (manufacturing standards of operational excellence) standards, or indirect participation through project support activitiesAbility to assess and triage deviations 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, procedures, technical studies, validation protocols, change controls, and engineering documents)Participate and contribute in/to Lean initiatives to help improve productivity within the local process team or quality organizationSupport project and process improvement initiatives for Plant Process Teams as a representative of the Quality functionApprove commissioning, qualification and validation documents for computer systems and equipment to ensure compliance with quality standardsNetwork with Global Parenteral Network sites as resources and benchmarking sources as applicableBasic Requirements:Bachelor's or equivalent (Science or Engineering degree)Demonstrate knowledge and understanding of manufacturing process and Quality SystemsAdditional Skills/Preferences:Experience in GMP production environments or Quality AssurancePrevious experience with Deviation/Event, Root Cause Investigation and Change Management processesProven ability to work independently and as part of a team to resolve issuesCritical thinking and understanding of compliance expectationsDemonstrate strong oral and written communication and interpersonal skillsDemonstrate technical writing and communication skillsDemonstrated decision making and problem-solving skillsStrong attention to detailProficiency with computer systems including Microsoft Office products, TrackWise, PMX, and SAPAdditional Information:Overtime may be required.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 Exam.

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