(Senior) QC Engineer

岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB

负责原材料、半成品、成品检测及环境监测等检测工作。
Be responsible for raw material, semi-finished products testing, finished products testing and environment monitoring program and so on.
支持/负责实验室检测方法的确认/验证工作。
Support/lead the validation and verification of laboratory testing methods.

主要职责 / MAIN ACCOUNTABILITIES

1. Routine testing /日常检测
负责完成原辅料包材、中间品、产品、生产及实验室环境控制、纯水等的QC检测，并做好结果的趋势分析。
Be responsible for QC test completed in time for raw material, packaging material, semi-product, finish product, production and QC lab environment, PW monitoring and complete trend analysis in time.
执行微生物检验，包括培养基适用性检查、菌株传代、接种、培养、鉴定及样品的检测
Perform microbiological testing, including media performance check, strain passage, inoculation, culture, identification and sample testing。
对QC相关文件进行复核，包含但不仅限于原材料检验、半成品检验、成品检验、稳定性检测、日常环境检测等。
Review all QC related document, including but not limited to raw material testing, semi-finished products testing, final goods testing, stability program, routine environment monitoring and so on.
支持/负责根据产品的放行单和相关文件出具COC。
Support/ Be responsible for COC issue according to the release notice and other controlled document.
支持/负责实验室相关的OOS/ 无效数据和质量相关的偏差调查。
Support/ Be responsible for lab OOS/ Invalid data and quality related deviation investigation. 

2. Instrument management/仪器管理
支持/负责实验室仪器设备的验证、校验，以及简单的问题排查。
Support/Be responsible for laboratory instrument validation, calibration, and basic trouble shooting.

3. Method/方法
支持/负责实验室检测方法的确认/验证工作。
Support/lead the validation and verification of laboratory testing methods.
支持/负责对QC人员进行检测方法相关的培训以及人员资质认定。
Support/ Be responsible for the training and qualification of QC personnel on testing methods.

4. Material/物料
负责确保试剂、培养基、耗材的安全库存，以及采购、接收、使用、库存盘点、效期管理等
Be responsible for ensuring the safety stock for reagent, media and consumables, and the management of purchasing, receiving, usage, stack taking and expiration date
负责实验室样品及留样的管理。
Be responsible for the management of test samples and retention samples.

5. Others /其他
遵守公司以及当地HSE政策、法规。
Comply with Health, Safety & Environment policies and local legal requirements.
确保所有操作满足相关质量法规要求。
Make sure all operations meet quality and related regulatory requirements.
支持内审及外审工作
Support internal/external audit

和其他部门进行沟通合作，确保工作任务的及时完成。
Collaborate with other related departments to make sure the assigned tasks are completed in time.

知识、语言和经验要求 / KNOWLEDGE, LANGUAGE AND EXPERIENCE

本科及以上学历，生物，化学，医学相关专业或工作经验
Bachelor degree (equivalent) or above educational background, majoring in biology, chemistry, medicine or related working experience .
语言技能：英语听、说、读、写熟练。
Language skills: Proficient in Listening , Speaking, Reading and Writing of English.
熟练的Word Excel等办公软件的操作
Skilled with Microsoft Word and Excel 
有良好的团队合作能力
Good interpersonal skill and team player. 
至少有10年以上微生物检测经验（包括培养基适用性检查、菌株传代、接种、培养、鉴定等）, 拥有理化检测经验者优先。
At least five years of microbiology testing experience, including media performance check, strain passage, inoculation, culture, strain identification etc. Experience with chemical testing is preferred.
熟悉ISO 19001, ISO 13485 和GMP等医疗器械相关的法规
Be familiar with relative medical device regulation, such as ISO 19001, ISO 13485 and GMP.