Quality Assurance Representative

Job Listing No: 9740000

Quality Assurance Representative

?Company Overview:Elanco is a global research-based company that develops and delivers product and services to enhance animal health and production. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 7,000 employees worldwide. Founded in 1954, Elanco is a division of Lilly. Our worldwide headquarters and research facilities are in Greenfield, Indiana.Responsibilities:The Quality Assurance Representative provides daily assistance and guidance to issues such as non-conformance investigations, change controls, procedure/manufacturing batch record changes, validations, batch disposition, and qualification activities. ?The Quality Assurance Representative works as a team member within the operations teams to achieve site goals while maintaining a strong quality mindset.Key Objectives/Deliverables:?Ensure regular presence in operational areas to monitor compliance and quality systemsAssist with ?batch disposition of incoming materials, semi-finished(antigen), and finished materials (vaccine)Lead, mentor, and coach operations and support personnel on quality mattersProvides guidance in operational areas to ensure robust quality systems and complianceSupport during internal/external regulatory inspectionsEffectively review/approve controlled documents to ensure quality attributes are met (i.e., non-conformances, procedures, technical studies, validation protocols, change controls, engineering documents, etc.)Assess ?non-conformances that occur within the local process teamCollaborates with cross-functional partners (i.e., operations, TSMS, engineering, QC, logistics, etc.) to investigate deviations, reduce compliance risks andAssist partners with writing change controls, deviations, and performing investigationsMentor and coach site personnel on Quality mattersAssist with and participate in Lean, Six-Sigma and Operational Excellence activities. Provide guidance to QA team and other areas for these initiatives.Provide guidance in root cause investigations and CAPAs utilizing Six Sigma tools.Assist with and oversee the implementation and adherence with the EGQSs.Assist with the day-to-day Quality operational activities (batch disposition, compliance checks, material handling)Serve on project teams, as assigned, to provide Quality and compliance guidance and inputBasic Qualifications:?? ?5 years of experience in Quality Systems regulated environmentBachelor's of Science Degree?Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.Additional Skills/Preferences:?? ?Preferable experience in the pharmaceutical or a healthcare related industryDemonstrate strong oral, written, and interpersonal skillsDemonstrated ability to work on a teamDemonstrated problem solving skillsRoot cause analysis and troubleshooting skillsProficiency with applicable computer systemsAbility to lead without authorityTechnical writing skillsTasks require entry to manufacturing areas which require appropriate Personal Protective EquipmentKnowledge of or experience in Lean, Six-Sigma or Operational ExcellenceExperience working in an FDA or USDA regulated industryExcellent communication, organization, and leadership skillsStrong interpersonal and team building skills; ability to lead and influence in a team environmentComputer skills – Excel, Word, and PowerPointMust not have contact with avian species (birds) at home due to the nature of the manufacturingM.S highly desirable.?Additional Information: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. ? ? ??? ? ??Removal Date: 21-Feb-2017

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