QC Supervisor

1. 岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB
l  作为QC主管,负责苏州QC实验室及运营，负责原材料、半成品、成品检测及环境监测等工作。
 Run QC lab in Suzhou as QC Supervisor, focus on raw material, semi-finished products testing, finished products testing and environment monitoring program and so on.
 l  建立运行维护的管理系统，在实验室建立GLP理念，保证法律法规、相关标准和梅里埃总部规范得到有效贯彻。
 Set up and maintain the Quality Control lab activities, build up GLP concept in Lab, make sure that all regulations, standards and Biomerieux Global directives are fully implemented.
 l  把分配到的工作进行组织和协调。Organize and coordinate the assigned work

2. 主要职责 / MAIN ACCOUNTABILITIES
1. 安全，卫生和安全/Safety, Health & Environment
 l  确保所有安全、卫生和环境要求和公司集团政策以及当地法规一致。
 Ensure that all applicable Safety, Health & Environment requirements are compliant to group policy and local legal requirements.
 2. 质量和法规符合/ Quality and Compliance
 l  和QA、生产、仓库、工业化等部门合作，确保所有操作满足相关质量法规要求。
 Collaborate with QA, Production, Warehouse, Industrial department and so on to make sure Right to operate through compliant to all related regulatory requirements.
 3 QC 业务/ QC Business
 l  负责日常的实验室人员管理及业务安排及资质培训
 Be responsible for routine QC staff management and business arrangement and training
 l  负责维护QC实验室管理及各种物料检验及环境控制等相关程序文件。
 Be responsible for maintaining SOPs for QC Lab management and material inspection/test and environment monitoring and so on
 l  负责监督QC的程序文件在实验室得到良好的执行，比如QC记录及时复核等等。
 Be responsible for supervising good lab practice in compliance with procedures, such as QC record review in time.
 l  负责QC仪器设备校验及维护管理和验证管理
 Be responsible for QC instrument/equipment calibration/maintenance/qualification management
 l  负责QC实验室的物料耗材等的库存管理工作
 Be responsible for safety storage management
 for QC material/consumable
 l  负责完成原辅料包材、中间品、产品等的QC检测，保证生产任务按时完成。
 Be responsible for QC test completed in time for
 raw material, packaging material, semi-product, finish product and so on  
 l  负责环境控制、纯水检验等的QC检测工作，并做好结果的趋势分析。
 Be responsible for QC test for environment/PW monitoring
 and complete trend analysis in time
 l  负责QC实验室的样品及留样管理及稳定性测试安排
 Be responsible for sample and retained sample
 management and stability test arrangement
 l  负责实验室相关的OOS调查，并支持不合格、偏差及投诉的调查
 Be responsible for OOS investigation in Lab and support investigation
 from NC/AR/complaint
 l  负责根据产品的放行单和相关文件出具COA
 Be responsible for COA issue according to
 product release document.
 l  负责QC日常检验数据的统计分析
 Be responsible for routine QC data analysis
 l  支持QMS内审及外审工作
 Support QMS
 internal/external audit
 l  保持和公司内部部门及美国工厂的良好沟通
 Keep good
 communication with business related department in site and sending site
 l  如需，参与到日常检验工作，及时完成检验
 If needed, participate in routine test to complete test task in time
履行由公司规程规定或由直属上级指派的其他任务。
Other tasks as defined in related company procedure, or assigned by the direct supervisor.
        
3. 知识、语言和经验要求 / KNOWLEDGE, LANGUAGE AND EXPERIENCE
l  本科及以上学历，生物，药学，医学相关专业
Bachelor degree (equivalent) or above educational background, majoring in biology, pharma, medicine or related working experience.
l  起码有5年以上微生物实验员经验，并有3年以上的实验室管理经验，熟悉实验室
At least 5 years work experience as microbial analyst and 3 year experience as lab supervisor, be familiar with lab management.
l  语言技能：英语和中文听、说、读、写熟练。
Language skills: Proficient in Listening, Speaking, Reading and Writing of both English & Chinese.
l  熟练的Word, Excel等办公软件的操作
Skilled with Microsoft Word and Excel
l  有良好的团队合作能力
Good Interpersonal skill and team player.
l  额外有气相色谱经验者优先
GC experience is a plus
l  熟悉ISO19001, ISO 13485 和GMP等医疗器械相关的法规规范
Be familiar with relative medical device regulation or codes, such as ISO 19001, ISO 13485 and GMP