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Advanced Technical Quality Control_Suzhou in Suzhou, China at Beckman Coulter Diagnostics

Date Posted: 2/7/2019

Job Snapshot

Job Description

Job ID: BEC013483

About Us

Founded in America by Professor Beckman and the Coulter brothers, Beckman Coulter Limited is dedicated to the to the development and sale of instruments, reagents, software and products that simplify and automate laboratory processing that are widely used in hospitals, clinics, and commercial laboratories worldwide. Clinical diagnostic tools implemented within company products include: laboratory automation systems, biochemical analytical systems, immunoassay systems, hematology systems, protein chemistry systems, urinalysis systems, microbiological detection and analysis systems, and blood bank analytical systems. In future developments, Beckman Coulter will continue to lead in the field of medical equipment research and development with cutting-edge technology and complete product lines, and continue to make outstanding contributions to the development of global scientific research! For more information, please visit www.beckmancoulter.com.


Description

本岗位工作偏重于“产品质量、过程质量”的“确认、符合”等相关质量活动。工作范围包含供应商来料检查、生产现场检查和成品检验等产品实现过程直接相关的检查和检验活动, 在实验室指定领域或工作小组从事所分配的检验工作,包含:
l 实验室检查,包材或原料检查(完成指定的实验操作)
l 实验室检查,仪器或生物分析(完成指定的实验操作)
l 过程中控制,在线或中间检查(完成指定的在线检查)
主要职责:
1. 在上述一个或多个领域内从事检验工作,了解实验室安全和质量控制要求;
2. 按规定的程序要求开展检验工作并维护合适的实验室检验记录;
3. 按规定的实验室安全要求进行检验和日常操作;
4. 可在血细胞试剂组、Sychron组或AU组配合工程师完成实验室检验工作;
5. 按文件要求进行血液学试剂、生化试剂、其他试剂的功能性试验;
6. 完成来料检验或检查、COA确认等供应商质量控制相关的工作。
7. 手工或仪器的无机离子分析技术(如Na, K, CL, F, pH, 磷、铁等分析);
8. 粒子数、渗透压、电导率、密度、水分、浊点等物理特性的常规分析;
9. 称量、鉴定、滴定、过滤等定性或半定量(如水、普通原料)的化学分析;
10. 原料的颜色、性状、密闭性、标签、条码、供应商COA等常规检查等;
11. 包装材料(GPM,BPM)的检查和放行;
12. 功能性包装材料(管理卡、校准条、条码、印刷包装材料等)检查与放行;
13. 生产现场质量检查、沟通和生产现场改进的推动;
14. 配料相关过程(清洁、称料、投料、配料、放行等)中间控制;
15. 包装相关过程(清洁、灌装、包装、中间品、标签条码等)中间控制;
16. 取样、留样、顾客产品质量抱怨的再检验和稳定性实验的开展;
17. 实验室常规设备(天平、加液器、pH 计等)的日常使用、维护、确认;
18. 按文件要求进行颗粒计数仪的维护,校准和确认;
19. 按文件要求进行火焰光度计、分光光度计的维护,校准和确认;
20. 按文件要求进行标准溶液的配制、标定、管理;
21. 使用图表,数据汇总等提高检验数据的分析能力和问题的沟通;
22. 完成质量控制主管或工程师安排的其他工作。

Job Requirements



Qualifications

l 1.化学或临床检验类大专三年以上(或本科一年以上)工作经验;
l 2.接受过产品相关的法律法规培训(如IVD-GMP等)和实验室安全培训;
l 3.专业性的化学分析能力和问题汇报能力;
l 4.具有汇报、分析、解决和发现潜在问题的能力;
l 5.在质量活动中有较好的组织能力,并有较好的管理能力和沟通技巧;
l 6.良好的管理时间技巧,掌握轻重缓急,人员管理和协调能力;
l 7.良好的英语沟通(英文读写和基本口语)能力;
l 8.良好的电脑运用技能。

Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.