Associate - Quality Assurance IAPI

Eli Lilly

United States

United States

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divh2Associate QA IAPI/h2pAt 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. Were looking for people who are determined to make life better for people around the world./ppThe Associate QA IAPI provides support to Indianapolis API Operations manufacturing and laboratories and ensures quality systems and GMP compliance. The QA Associate provides assistance and guidance in deviation investigations, change control proposals, procedure and master production revisions, validations and batch dispositions. The QA Associates position is essential for maintaining quality systems, ensuring GMP compliance and in the preparation for inspections by various regulatory agencies./ppKey Objectives/Deliverables:/pulliProvide direct quality oversight of production, warehouse/material management, engineering, automation and laboratory operations./liliReview and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods and computerized system validations./liliProvide quality guidance and recommendations with regard to manufacturing, materials, utilities, maintenance and laboratory issues./liliParticipate in aberrant data investigations./liliConduct analytical data review including stability data./liliDisposition API Intermediates and raw materials, as appropriate./liliProvide coaching, feedback and mentoring to QA Specialists as it relates to execution of quality systems./liliInvestigate customer complaints./liliParticipate in and/or support recalls, as appropriate./liliContribute to and review Annual Product Reviews (APR), laboratory periodic reviews and equipment/computer system periodic reviews, as appropriate./liliConduct gap assessments of global requirements and ensure implementation of the governing standards./liliParticipate in and/or lead self-inspection activities./liliParticipate in and/or support regulatory inspections and audits./liliMaintain and improve quality systems./liliAssist others in the interpretation of regulatory and corporate requirements./li/ulpBasic Requirements:/pulliBS in Engineering or a science-related field or equivalent experience./li/ulpAdditional Preferences:/pulliExperience with computer system validation./liliDemonstrated strong written and verbal communications skills./liliStrong attention to detail./liliProficiency with computer system applications./liliKnowledge of cGMPs and quality systems./liliUnderstanding of statistical tools and analysis./liliExcellent interpersonal skills and networking skills./liliAbility to organize and prioritize multiple tasks./liliPrevious experience in QA, QC, Manufacturing, Engineering, Tech Services or Regulatory Affairs./li/ulpEducation Requirements:/pulliBS in Engineering or science-related field or equivalent experience./li/ulpOther Information:/pulliMust complete Learning Plan for Associate QA IAPI./liliNo certifications required./liliTasks require entering manufacturing and laboratory areas which require wearing appropriate PPE./liliMust support 24 hour/day operations./li/ulpThe job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification./ppLilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance./ppLilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status./ppOur employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Womens Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups./ppActual compensation will depend on a candidates education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400./ppFull-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lillys compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees./p/div

United States

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