QA Dry External Intermediates Manufacturing Associate

Eli Lilly

United States

United States

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divh2Dry Em Quality Assurance Representative/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 Dry EM Quality Assurance Representative provides support to all quality activities at Contract Manufacturing organizations (CMs) related to the manufacturing process of intermediates such as spry dry dispersion (SDD). The QA Representative position is essential for ensuring that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments./ppKey Objectives/Deliverables:/pulliServe as a liaison between CMs and Lilly./liliProvide quality oversight of CMs including being the initial point of contact for all quality-related issues./liliEscalate quality issues at CMs to Lilly QA management./liliAssist in the establishment and revisions of Quality Agreements with affiliates and customers./liliEnsure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs)./liliProvide quality oversight of Lilly/Dry-EM Quality Plans/liliCoordinate and perform QA responsibilities of API shipments./liliParticipate in regulatory inspection preparations with CMs. Provide on-site support during inspections./liliParticipate on the Technical Review Board/liliEvaluate and disposition batches of intermediate, if required./liliEnsure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release./liliProvide quality support of the manufacturing process for intermediates (such as Spry dry dispersion technology) with the focus on holistic review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures./liliAssess the impact of deviation investigations and changes and ensure that all appropriate records are documented and retrievable./liliEnsure all processes are in an appropriate state of control./liliMaintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product./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./liliParticipate in APR activities./liliParticipate in projects to improve productivity./liliParticipate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams./li/ulpBasic Requirements:/pulliBS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences./lili3+ years of GMP manufacturing knowledge and/or experience in API/intermediates or finished product manufacturing, QC, QA or Engineering./li/ulpAdditional Preferences:/pulliExperience in quality support for Quality Control activities/liliThorough technical understanding of quality systems and regulatory requirements./liliKnowledge of pharmaceutical manufacturing operations./liliDemonstrated coaching and mentoring skills./liliExperience in root cause analysis./liliDemonstrated application of statistical skills./liliDemonstrated strong written and verbal communications skills./liliStrong attention to detail./liliProficiency with computer system applications./liliExcellent interpersonal skills and networking skills./liliAbility to organize and prioritize multiple tasks./liliAbility to influence diverse groups and manage relationships./li/ulpAdditional Information:/pulliMust complete required training for Dry-EM Quality Assurance./liliNo certifications required./liliMust be able to support 24 hour/day operations./liliWillingness to travel, expected 30% travelling./li/ulpLilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you need 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./p/div

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