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QC Specialist
9-12K/月江苏省-南通/本科及以上/3-5年
李秀英一周前来过
北京艾锐达管理顾问有限公司
职位详情
岗位职责
任职要求：
• Education:
College or University level. (Microbiology, Biochemistry, pharmaceutical, food etc.)
学院或大学水平。（微生物学、生物化学、制药、食品等）
• Working Experience:
1. Attainment of qualified/responsible person status under local/international legislative requirements.
根据当地/国际立法要求获得合格/负责人身份。
2. At least 3 years of Micro biological tests experiences in QC lab (experience in biological lab will add value). Familiar with CHO, HEK293 and Vero cell. SAP experience will add value.
至少3年QC实验室微生物检测经验（有生物实验室经验者优先），熟悉CHO、HEK293和Vero细胞、SAP者优先。
3. Cross-functional working environment.
跨职能工作环境
4. Team working.
团队协作
• Technical & Professional Knowledge:
1. Local language, Basic English speaking, good English reading and understanding
当地语言，基础英语口语，阅读和理解能力。
2. Skillful in using office application software (MS-Word, MS-Excel, MS-Outlook)
熟练使用办公应用软件（MS-Word、MS-Excel、MS-Outlook）
3. Be able to work independently
能够独立工作
4. Perform the analysis work within cGMP environment and minimize laboratory errors.
在cGMP环境下进行分析工作，尽量减少实验室错误。
岗位职责：
• Perform laboratory tests (such as Cell growth test, Cell Thawing, Cell Passing, Freezing Cells, Cell counting, Cell Adaptation, cell bank management, EM, Microbial limit test, sterility test, endotoxin test, cell culture test and simple physical and chemical test) through operating standard and specialized laboratory equipment in accordance with SOPs, working instructions procedures and testing monographs, and document properly in a timely manner.
按照相应的标准操作规程、工作指导书和测试方法进行实验室测试（如细胞生长测试、细胞冻存、细胞传代、细胞适应性、环境监测、微生物限度检测、无菌检测、细菌内毒素、细胞培养和基本的理化检测），并及时妥善记录。
• Responsible for sampling of in-coming goods including packaging material, water, responsible for sampling room running and maintenance.
负责来料取样，包括原料包材、水；负责取样间的运行与维护。
• Perform lab equipment qualification/calibration, method transfer and validation analytics assigned.
根据方案进行实验室设备确认、方法转移和验证。
• Contribute to problem solving associated with laboratory work such as OOT/OOS/DEV investigation.
致力于解决与实验室工作相关的问题，例如OOT/OOS/DEV 调查。
• Maintain high level of safety, environmental protection and housekeeping in all laboratory operations, comply to relevant Quality System cGMP requirement. Contribute also in the system establishment.
在所有实验室操作中保持高水平的安全、环境保护和内务管理，遵守相关的质量体系 cGMP 要求。也为系统的建立做出贡献。
• Strictly comply with company EHS safety regulations and master skill of safety work and emergency rescue knowledge.
严格遵守公司EHS的安全规定，掌握安全工作技能和应急救援的知识。
• Take responsibilities in assigned projects as appropriate.
在分配的项目中适当承担相应的责任。
• Be a valuable team member of Quality organization and develop self and others (e.g. junior lab staff/new comer training) through close teamwork and cross functional/sectional activities. Be a continuous improver.
成为质量组织中有价值的团队成员，通过紧密的团队合作和跨职能/跨部门活动发展自我和他人（例如初级实验室工作人员/新人培训），持续改进。
• Maintain and control Biological-lab consumable, microbiological media, strains and biological indicator.
维护和控制生物实验室的耗材、微生物培养基、菌种和生物指示剂。
• Actively participate in quality culture building and quality related activities
积极参与工厂的质量文化建设和质量相关活动
• Actively report quality related events and participate in continuous quality improvement activities
主动汇报质量相关事件，积极参与工厂的质量持续改进的活动
• Maintain the high GMP compliance and DI for Bio QC lab
将生物实验室维持在一个较高的GMP和DI水平
• Contribute to digital visualization
致力于数字可视化工作
• Education:
College or University level. (Microbiology, Biochemistry, pharmaceutical, food etc.)
学院或大学水平。（微生物学、生物化学、制药、食品等）
• Working Experience:
1. Attainment of qualified/responsible person status under local/international legislative requirements.
根据当地/国际立法要求获得合格/负责人身份。
2. At least 3 years of Micro biological tests experiences in QC lab (experience in biological lab will add value). Familiar with CHO, HEK293 and Vero cell. SAP experience will add value.
至少3年QC实验室微生物检测经验（有生物实验室经验者优先），熟悉CHO、HEK293和Vero细胞、SAP者优先。
3. Cross-functional working environment.
跨职能工作环境
4. Team working.
团队协作
• Technical & Professional Knowledge:
1. Local language, Basic English speaking, good English reading and understanding
当地语言，基础英语口语，阅读和理解能力。
2. Skillful in using office application software (MS-Word, MS-Excel, MS-Outlook)
熟练使用办公应用软件（MS-Word、MS-Excel、MS-Outlook）
3. Be able to work independently
能够独立工作
4. Perform the analysis work within cGMP environment and minimize laboratory errors.
在cGMP环境下进行分析工作，尽量减少实验室错误。
岗位职责：
• Perform laboratory tests (such as Cell growth test, Cell Thawing, Cell Passing, Freezing Cells, Cell counting, Cell Adaptation, cell bank management, EM, Microbial limit test, sterility test, endotoxin test, cell culture test and simple physical and chemical test) through operating standard and specialized laboratory equipment in accordance with SOPs, working instructions procedures and testing monographs, and document properly in a timely manner.
按照相应的标准操作规程、工作指导书和测试方法进行实验室测试（如细胞生长测试、细胞冻存、细胞传代、细胞适应性、环境监测、微生物限度检测、无菌检测、细菌内毒素、细胞培养和基本的理化检测），并及时妥善记录。
• Responsible for sampling of in-coming goods including packaging material, water, responsible for sampling room running and maintenance.
负责来料取样，包括原料包材、水；负责取样间的运行与维护。
• Perform lab equipment qualification/calibration, method transfer and validation analytics assigned.
根据方案进行实验室设备确认、方法转移和验证。
• Contribute to problem solving associated with laboratory work such as OOT/OOS/DEV investigation.
致力于解决与实验室工作相关的问题，例如OOT/OOS/DEV 调查。
• Maintain high level of safety, environmental protection and housekeeping in all laboratory operations, comply to relevant Quality System cGMP requirement. Contribute also in the system establishment.
在所有实验室操作中保持高水平的安全、环境保护和内务管理，遵守相关的质量体系 cGMP 要求。也为系统的建立做出贡献。
• Strictly comply with company EHS safety regulations and master skill of safety work and emergency rescue knowledge.
严格遵守公司EHS的安全规定，掌握安全工作技能和应急救援的知识。
• Take responsibilities in assigned projects as appropriate.
在分配的项目中适当承担相应的责任。
• Be a valuable team member of Quality organization and develop self and others (e.g. junior lab staff/new comer training) through close teamwork and cross functional/sectional activities. Be a continuous improver.
成为质量组织中有价值的团队成员，通过紧密的团队合作和跨职能/跨部门活动发展自我和他人（例如初级实验室工作人员/新人培训），持续改进。
• Maintain and control Biological-lab consumable, microbiological media, strains and biological indicator.
维护和控制生物实验室的耗材、微生物培养基、菌种和生物指示剂。
• Actively participate in quality culture building and quality related activities
积极参与工厂的质量文化建设和质量相关活动
• Actively report quality related events and participate in continuous quality improvement activities
主动汇报质量相关事件，积极参与工厂的质量持续改进的活动
• Maintain the high GMP compliance and DI for Bio QC lab
将生物实验室维持在一个较高的GMP和DI水平
• Contribute to digital visualization
致力于数字可视化工作
任职要求
无
工作地点
- 南通崇川区江港路39号
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