Supplier Quality Specialist
对于质量系统领域的制造服务，支持供应商和原材料变化控制。你是什么样子：作为供应商变化控制的拥有者加入生物制药生产业的质量系统部门。在这个角色中，你将确保对原料或组件的所有变化都得到正确评估，记录和实施，并通过关闭管理与供应商有关的不符合性和 CAPA.技术部分：·学士学位科学，具有四 (4) 年经验在制药或监管行业中的科学家。·双语 （英语和西班牙语）. ·项目管理技能。·转换：行政，如有必要。· 工作模式：远程，需要进行现场审计。· 在以下过程中经验：· 变化控制，包括供应商的变化通知和与供应商相关质量记录的影响评估 · 原材料和组件，包括规格和材料文档 · TrackWise 和 SAP · 非合规/CAPA 调查编写和关闭管理人格部分：· 想象自己在实验室里...拥有所有你需要的设备来发挥多任务，科学，创造性 （为了完成所有这些实验！）的技能。想象一下一个健康的竞争，团队合作，道德和以一切可能的方式使用科学方法的环境。如果你喜欢这种听起来，那么这可能是你的工作。把它带来！作为一个合适的部分，你会：（每天在工作中）·自主控制从启动到关闭的供应商相关变化，确保及时并符合实施。·评估供应商变化通知和质量记录，以确定它们对原材料，工艺和产品质量的影响，与供应商质量，材料管理，质量控制和制造协调。· 启动，修订和批准生产程序和供应商变化影响的原材料文档。作为文件所有者。· 在 TrackWise 和 SAP 中追踪和记录变化控制活动。·确保所有与供应商有关的不符合性均在已确定的目标范围内进行排序。· 作者调查报告并执行纠正行动。· 在既定目标内管理 NC/CAPA 关闭。·监控和沟通供应商和事件趋势。·协助生成与流程和物质变化相关的培训资料。谁是我们？
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For Manufacturing Services in the Quality Systems area, supporting supplier and raw material change control.
WHAT MAKES YOU A FIT:
Join the Quality Systems area of a biopharmaceutical manufacturing operation as the owner of supplier change control. In this role, you’ll ensure every change to a raw material or component is assessed, documented, and implemented correctly, and you’ll manage supplier-related non-conformances and CAPAs through closure.
The Technical Part:
- Bachelor's Degree in a Science, with four (4) years of experience as a Scientist in the pharmaceutical or regulated industry.
- Bilingual (English & Spanish).
- Project Management skills.
- Shift: Administrative, as needed.
- Work Model: Remote, with on-site presence required for audits as needed.
- Experience in:
- Change Control processes, including supplier change notifications and impact assessments of supplier-related quality records
- Raw materials and components, including specifications and material documentation
- TrackWise and SAP
- Non-conformance/CAPA investigation authoring and closure management
The Personality Part:
· Picture yourself in a lab… with all the equipment you need to put your multitasking, scientific, creative (to come up with all those experiments!) skills to work. Picture as well an environment of healthy competition, teamwork, being ethical, and of using the scientific method in all ways possible. If you like how this sounds, then this might be the job for you. Bring it on!
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
- Own supplier-related change controls from initiation through closure, ensuring timely and compliant implementation.
- Assess supplier change notifications and quality records to determine their impact on raw materials, processes, and product quality, coordinating with Supplier Quality, Materials Management, Quality Control, and Manufacturing.
- Initiate, revise, and approve manufacturing procedures and raw material documentation affected by supplier changes. Serve as a document owner.
- Track and document change control activities in TrackWise and SAP.
- Ensure all supplier-related Non-conformances are triaged within the established goal.
- Author investigation reports and execute corrective actions.
- Manage NC/CAPA closure within established goal.
- Monitor and communicate supplier and incident trends.
- Assist in the generation of training materials related to process and material changes.
WHO WE ARE:
We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS!
Are you the next piece?
Originally posted on Himalayas