QA Associate

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

统计学检查要求: Responsibility for Statistical Inspection

-确保良好的文件行为，符合灯检操作文件要求 -Ensures Good Documentation practices and compliance with inspection and operational related documents

-依据生产计划要求，完成苏州工厂的人工目视检查的工作任务，以及完成SOP所要求的房间清洁 -Complete manual visual statistical sorting inspection for Suzhou Parenteral products in alignment with production schedule, and also to finish the room clean base on the SOP requirements

-依据批记录灯检部分的要求来记录产品的缺陷分类 -Document defect classification information within manufacturing ticket associated with statistical inspection

-确保从最终半成品中进行取样，以及送样至实验室并且完成相关文件记录 -Ensure appropriate sampling of final semi-finished product, delivering the samples to the appropriate laboratories and completing all associated documentation

其他

Others

-支持生产操作人员完成培训以及资质认定 -Support Operational inspection personnel with completion of required training and qualification activities

-建立工艺和设备知识，尤其是与笔芯灌装控制策略相关方面 -Develop process and equipment knowledge, in particular as it relates to the control strategy for cartridge filling

-执行/支持偏差评估或调查 -Perform/support deviation assessment or investigations

-为灯检工序提供日常质量监督管理，包括工单日志审核/批记录审核/日常运营质量相关问题处理等

-Act as quality routine oversight for visual inspection process, include workorder/log review, batch record review, routine quality related issue handling, and so on.......

-灵活支持EM团队公用系统及环境监测取样活动或shift QA团队任务

-Flexible support EM team utility/environment monitor sampling activities or shift QA team task execution

基本要求

Basic Requirement： 大专及以上学历，药学、化学或相关学科专业 Associate degree or above, majored in pharmaceuticals, chemistry or related sciences. 1-3年的生产或QA或QC经验 One to three years of experience in production or QA or QC 能够通过年度视力检查，应无色盲 Pass an annual vision test and be free of color blindness 远距离和近距离视力测验，均应为4.9及以上（矫正后视力应为5.0及以上） Must be equivalent to 4.9 or above vision acuity(5.0 or above correctable vision acuity) 较强的细节关注能力 Strong Attention to detail 根本原因分析、问题解决技巧，以及要求具备良好的沟通技巧 Root cause analysis/Troubleshooting skills and requires good communication skills

其他要求

Additional Preference: 具备生产、工程、QC、QA、技术服务或法规的相关经验 Experience in Production, Engineering, QC, QA, Technical Services, or Regulatory is desirable. 可能需要加班或24h翻班 Overtime or 24h shift may be required. 在确认、验证及日常生产期间，将被要求携带寻呼机或者手机，在不当班时间内回答生产问题 During qualification, validation, and routine operations, will be required to wear pager or carry a phone for off- shift coverage and respond to operational issues. 申请者可能会在注射药物工厂的各种区域工作。由于注射剂工厂存在部分过敏原，在申请这些岗位时，过敏原的流动性要求和暴露量应当被考虑。 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.

Lilly 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 ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly 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.

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