Sarah Rainey work email
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Sarah Rainey personal email
•Demonstrated knowledge and application of federal regulations including quality systems and compliance•Demonstrated auditing skills and managment of business partners•Strong critical thinking/problem solving skills with particular expertise in defining business processes•Demonstrated strong organizational skills, including the ability to prioritize workload and manage change.•Excellent written, oral communication and presentation skills•Ability to work independently and collaboratively on resolution of significant issues and new projectsSix Sigma Green Belt certifiedISO9001:2015 Lead Auditor certified
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Global Regulatory Process Excellence LeadViatris Jun 2023 - PresentPittsburgh, Pennsylvania, Us -
Regulatory Implementation LeadCorteva Agriscience Oct 2022 - Jun 2023Indianapolis, Indiana, UsResponsible for defining and championing the implementation processes and associated activities for the execution of Regulatory plans. -
Global Regulatory Program ManagerCorteva Agriscience Aug 2018 - Oct 2022Indianapolis, Indiana, UsAccountable for planning, management and sustainable implementation of the regulatory programs and projects for a portfolio of molecules in in alignment with regulatory strategies. Manages plan of work and budgeting.
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Scholarship ChairAsq 2016 - Dec 2018Milwaukee, Wi, Us -
Scholarship ChairAsq 2016 - 2016Milwaukee, Wi, Us
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Quality Assurance SpecialistCorteva Agrisciencetm Agriculture Division Of Dowdupont Nov 2017 - Aug 2018
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Quality Assurance SpecialistDow Agrosciences Feb 2014 - Nov 2017Indianapolis, In, UsLead implementation of quality management systems partnering with R&D, Operations and Regulatory functions. Identify and establish quality standards and operating discipline to ensure that product quality and product integrity are maintained through all phases of development and commercialization. -
Quality ConsultantEli Lilly And Company Feb 2007 - Jan 2014Indianapolis, Indiana, UsImplement quality systems for the US Affiliate, Sample Compliance OrganizationAssess, establish and support quality systems within LillyUSASupport Business Partner Alliances ( risk assessments, Quality Agreements, Business Rules, Audits)Apply regulations to business to ensure compliance -
Recall CoordinatorEli Lilly And Company Sep 2003 - Feb 2007Indianapolis, Indiana, UsCoordinate and execute market actions (recalls, corrections, withdrawals) for FDA regulated areasPrepare and submit market action status reports to the FDASupport OUS sites involved in market actionsPrepare quarterly global market action metrics and reportsProject manager for mock market action exercise.
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Board MemberPdma Alliance Jan 2010 - Dec 2011
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Quality Control ManagerNational Notification Center Feb 2000 - Aug 2003Implemented and managed procedure and policy system, deviations and change managementPerformed internal audits, hosted client audits, included responding to observationsProject manager for retrospective validation of computer systemDefined and implemented training program
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Quality Control RepresentativeEli Lilly And Company Apr 1998 - Feb 2000Indianapolis, Indiana, UsResponsible for quality oversight of a multiple step manufacturing process to ensure compliance with quality and GMP requirements in an FDA regulated processDefined, managed and implemented quality deliverables for the processSupervised quality control assistants
Sarah Rainey Skills
Sarah Rainey Education Details
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Indiana University IndianapolisCytotechnology -
Jefferson Community College, KentuckyMedical Technologist
Frequently Asked Questions about Sarah Rainey
What company does Sarah Rainey work for?
Sarah Rainey works for Viatris
What is Sarah Rainey's role at the current company?
Sarah Rainey's current role is Global Regulatory Process Excellence Lead.
What is Sarah Rainey's email address?
Sarah Rainey's email address is ra****@****lly.com
What schools did Sarah Rainey attend?
Sarah Rainey attended Indiana University Indianapolis, Jefferson Community College, Kentucky.
What skills is Sarah Rainey known for?
Sarah Rainey has skills like Fda, Validation, Pharmaceutical Industry, Gmp, Quality Assurance, Quality Auditing, Quality System, Change Control, Quality Control, Capa, Quality Process Development, Product Quality.
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