QC Analyst / 质控分析员（微生物检测方向）
浙江康泰伦特江元堂生物科技有限公司
- 公司规模：150-500人
- 公司性质：合资(非欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2017-07-19
- 工作地点：海宁
- 招聘人数：1人
- 工作经验：2年经验
- 职位类别：质量检验员/测试员
职位描述
职位描述：
I. Essential Functions:
确保及时完成原辅料、中间产品、成品及稳定性样品的测试，及时完成分析方法验证、确认和转移等相关实验。执行OOS 调查以及相关CAPA计划的建立、执行。
Complete the testing for raw materials, packing material, intermediate products, finished products, and the stability samples in time, furthermore complete the method validation, verification and transfer in time. Conduct the OOS investigation and CAPA plan set up if applicable.
II. Specific Duties, Activities, and Responsibilities:
? 按期按照SOP原料标准，成品标准完成进厂原辅料、包装材料、成品、稳定性产品及其他检测项目的检验。
Perform the testing for raw materials, packing materials, finished products, the stability study products, and other testing according to the approved SOP, raw material and product specification and schedule.
? 负责实验室的试剂、标准品和实验室消耗品的管理，测试液的配制和标定，并维持足够的库存以保证检验活动。
Supervise the maintenance of lab consumables and chemical reagents, standards, medium etc. Maintain sufficient/adequate stock of regents and glassware necessary to support testing activities.
? 实验室仪器的日常维护，校准以及预防性维护。
Ensure the calibration and maintenance status of laboratory equipment. Perform routine maintenance, preventive maintenance for laboratory instruments and equipment.
? 维护、回顾、编写实验室文件，记录以及控制表。
Maintain/ Review/Develop laboratory documents, records and control chart.
? 严格按照GLP/GMP/CNAS要求进行操作，并进行持续改进。
Strictly follow the guidance to GLP/GMP, and forward any opportunities to improve GLP/GMP program.
? 管理样品，留样，稳定性样品，管理台账，按时执行相关测试或者销毁过期样品。
Manage the sample and retain sample, stability sample, and manage a trace list with the retain sample and stability sample, on time to do the test or destroy the expired sample.
? 发现OOT和OOS时，进行调查以及CAPA计划制定。
Quickly and objectively perform lab investigation on out of specification cases (OOT&OOS), and implement CAPA effectively.
? 进行方法优化，编写草案/文件并执行方法转移/检测设备验证。解决检验方法及检验设备的故障。
Methods optimization, Prepare protocol/document and perform test method transfer/ test instrument validation. Conduct trouble shooting of the test methods and instrument operation.
? 理解并实施实验室的环境、健康和安全规则。推动发展EHS的管理。按要求穿戴PPE。及时向主管汇报任何事故或Near Misses（不安全的行为，情况）。
Understand and practice laboratory Environment, Health and Safety rules. Forward any opportunities to improve the EHS program to supervision. Wear all PPE as required. Report any EHS incidents and/or Near Misses (unsafe acts and conditions) promptly to supervision.
? 与主管合作，持续提高实验室绩效
Cooperate with his/her supervision, continuous improves lab’s performance.
? 完成主管临时指派的任务。
Willing to take extra tasks/works assigned to him/her by his/her supervision.
III. Position Requirements:
Education or Equivalent: (Minimum required to perform job)
? 大专以上学历，化工，食品或其他相关专业。
College or above in chemistry, food, or related.
? 食品，营养品，或者制药工厂实验室2年以上相关工作经验。有CNAS/GMP 实验室工作经验尤佳。
At least 2 years extensive experience in Food, Nutritional or Pharmaceutical manufacturing Lab is preferred. Work experience under CNAS circumstance is preferred.
Knowledge/Skills Requirements:
? 熟悉检测方法和设备维护
Be familiar with test methods and lab instrument maintenance.
? 熟悉操作维护检测仪器，例如HPLC,GC,AA,UV,IR等检验设备。
Be familiar with operation and maintenance of HPLC, GC, AA, UV, IR, etc.
? 有良好的GLP/GMP知识
Have a good awareness and practice of GLP/GMP.
? 良好的英文读写能力
Good English language skills, reading and writing.
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I. Essential Functions:
确保及时完成原辅料、中间产品、成品及稳定性样品的测试，及时完成分析方法验证、确认和转移等相关实验。执行OOS 调查以及相关CAPA计划的建立、执行。
Complete the testing for raw materials, packing material, intermediate products, finished products, and the stability samples in time, furthermore complete the method validation, verification and transfer in time. Conduct the OOS investigation and CAPA plan set up if applicable.
II. Specific Duties, Activities, and Responsibilities:
? 按期按照SOP原料标准，成品标准完成进厂原辅料、包装材料、成品、稳定性产品及其他检测项目的检验。
Perform the testing for raw materials, packing materials, finished products, the stability study products, and other testing according to the approved SOP, raw material and product specification and schedule.
? 负责实验室的试剂、标准品和实验室消耗品的管理，测试液的配制和标定，并维持足够的库存以保证检验活动。
Supervise the maintenance of lab consumables and chemical reagents, standards, medium etc. Maintain sufficient/adequate stock of regents and glassware necessary to support testing activities.
? 实验室仪器的日常维护，校准以及预防性维护。
Ensure the calibration and maintenance status of laboratory equipment. Perform routine maintenance, preventive maintenance for laboratory instruments and equipment.
? 维护、回顾、编写实验室文件，记录以及控制表。
Maintain/ Review/Develop laboratory documents, records and control chart.
? 严格按照GLP/GMP/CNAS要求进行操作，并进行持续改进。
Strictly follow the guidance to GLP/GMP, and forward any opportunities to improve GLP/GMP program.
? 管理样品，留样，稳定性样品，管理台账，按时执行相关测试或者销毁过期样品。
Manage the sample and retain sample, stability sample, and manage a trace list with the retain sample and stability sample, on time to do the test or destroy the expired sample.
? 发现OOT和OOS时，进行调查以及CAPA计划制定。
Quickly and objectively perform lab investigation on out of specification cases (OOT&OOS), and implement CAPA effectively.
? 进行方法优化，编写草案/文件并执行方法转移/检测设备验证。解决检验方法及检验设备的故障。
Methods optimization, Prepare protocol/document and perform test method transfer/ test instrument validation. Conduct trouble shooting of the test methods and instrument operation.
? 理解并实施实验室的环境、健康和安全规则。推动发展EHS的管理。按要求穿戴PPE。及时向主管汇报任何事故或Near Misses（不安全的行为，情况）。
Understand and practice laboratory Environment, Health and Safety rules. Forward any opportunities to improve the EHS program to supervision. Wear all PPE as required. Report any EHS incidents and/or Near Misses (unsafe acts and conditions) promptly to supervision.
? 与主管合作，持续提高实验室绩效
Cooperate with his/her supervision, continuous improves lab’s performance.
? 完成主管临时指派的任务。
Willing to take extra tasks/works assigned to him/her by his/her supervision.
III. Position Requirements:
Education or Equivalent: (Minimum required to perform job)
? 大专以上学历，化工，食品或其他相关专业。
College or above in chemistry, food, or related.
? 食品，营养品，或者制药工厂实验室2年以上相关工作经验。有CNAS/GMP 实验室工作经验尤佳。
At least 2 years extensive experience in Food, Nutritional or Pharmaceutical manufacturing Lab is preferred. Work experience under CNAS circumstance is preferred.
Knowledge/Skills Requirements:
? 熟悉检测方法和设备维护
Be familiar with test methods and lab instrument maintenance.
? 熟悉操作维护检测仪器，例如HPLC,GC,AA,UV,IR等检验设备。
Be familiar with operation and maintenance of HPLC, GC, AA, UV, IR, etc.
? 有良好的GLP/GMP知识
Have a good awareness and practice of GLP/GMP.
? 良好的英文读写能力
Good English language skills, reading and writing.
职能类别： 质量检验员/测试员
公司介绍
Catalent Overview
Catalyst + Talent! Our name combines these ideas. As the world’s #1 drug development, delivery and supply partner with over 80 years of experience, we are the catalyst for your success. We have helped thousands of innovators by optimizing and manufacturing thousands of pharmaceutical, biologic, consumer health, beauty products and animal health utilizing our superior and innovative drug delivery technologies to improve their value to patients and consumers.
Catalent is a vibrant growing community of 8,500 global employees with the passion to unlock the potential of your product. From early development to clinical supply and commercial manufacturing, our 30+ global site teams support you through all phases of development, delivery, and supply, accelerating your product’s path to market in segments. Our legacy of drug development goes much deeper, incorporating the inventions and innovations which have transformed the pharmaceutical industry. On July 30, 2014 Catalent announced its initial public offering and became a publicly traded on the New York Stock Exchange under the ticker symbol CTLT.
Additionally, we have over 700 products in development at any time and partner with
• 87 of the top 100 pharmaceutical companies
• 24 of the top 25 biotechnology companies
• 22 of the top 25 generic drug companies
• 21 of the top 25 consumer health companies
Catalent. More products. Better treatments. Reliably supplied.™
For more information please visit our website www.catalent.com
康泰伦特概览
催化剂 + 人才！我们的名称结合于这两个概念。作为全球第一的药品研发、给药技术及供应的合作伙伴，我们已拥有80多年的经验，也是客户成功的催化剂。我们与成千上万家企业进行合作，运用全球最尖端领先的给药技术去协助客户优化及生产过几千种药品及生物制剂、健康消费品、美容产品和动物健康品，从而提升客户在患者与消费者心中的价值。
康泰伦特是一家朝气蓬勃的公司，在全球拥有8500名雇员为客户提供最专业的服务。我们在全球拥有30多家工厂，从临床研发初期到正式生产上市的每一个环节（研发、给药技术、供应），我们均可根据客户不同产品的市场定位和需求提供本领域最专业技术解决方案。我们专注于药品研发持续性的革新与创新，并且为整个制药行业的变革带来深远的意义。康泰伦特于2014年7月30日正式宣布首次在美国纽约证券交易所挂牌上市，股票代号：CTLT。
此外，我们拥有700多个产品随时在与客户进行研发合作：
• 全球前100强中的87家制药企业
• 全球前25强中的24家生物技术企业
• 全球前25家中的22家仿制药企业
• 全球前25家中的21家健康消费品企业
康泰伦特。更多的产品。更好的治疗。可靠地供应。™
获取更多信息请浏览公司官网 www.catalent.com
Catalyst + Talent! Our name combines these ideas. As the world’s #1 drug development, delivery and supply partner with over 80 years of experience, we are the catalyst for your success. We have helped thousands of innovators by optimizing and manufacturing thousands of pharmaceutical, biologic, consumer health, beauty products and animal health utilizing our superior and innovative drug delivery technologies to improve their value to patients and consumers.
Catalent is a vibrant growing community of 8,500 global employees with the passion to unlock the potential of your product. From early development to clinical supply and commercial manufacturing, our 30+ global site teams support you through all phases of development, delivery, and supply, accelerating your product’s path to market in segments. Our legacy of drug development goes much deeper, incorporating the inventions and innovations which have transformed the pharmaceutical industry. On July 30, 2014 Catalent announced its initial public offering and became a publicly traded on the New York Stock Exchange under the ticker symbol CTLT.
Additionally, we have over 700 products in development at any time and partner with
• 87 of the top 100 pharmaceutical companies
• 24 of the top 25 biotechnology companies
• 22 of the top 25 generic drug companies
• 21 of the top 25 consumer health companies
Catalent. More products. Better treatments. Reliably supplied.™
For more information please visit our website www.catalent.com
康泰伦特概览
催化剂 + 人才！我们的名称结合于这两个概念。作为全球第一的药品研发、给药技术及供应的合作伙伴，我们已拥有80多年的经验，也是客户成功的催化剂。我们与成千上万家企业进行合作，运用全球最尖端领先的给药技术去协助客户优化及生产过几千种药品及生物制剂、健康消费品、美容产品和动物健康品，从而提升客户在患者与消费者心中的价值。
康泰伦特是一家朝气蓬勃的公司，在全球拥有8500名雇员为客户提供最专业的服务。我们在全球拥有30多家工厂，从临床研发初期到正式生产上市的每一个环节（研发、给药技术、供应），我们均可根据客户不同产品的市场定位和需求提供本领域最专业技术解决方案。我们专注于药品研发持续性的革新与创新，并且为整个制药行业的变革带来深远的意义。康泰伦特于2014年7月30日正式宣布首次在美国纽约证券交易所挂牌上市，股票代号：CTLT。
此外，我们拥有700多个产品随时在与客户进行研发合作：
• 全球前100强中的87家制药企业
• 全球前25强中的24家生物技术企业
• 全球前25家中的22家仿制药企业
• 全球前25家中的21家健康消费品企业
康泰伦特。更多的产品。更好的治疗。可靠地供应。™
获取更多信息请浏览公司官网 www.catalent.com
联系方式
- Email：recruiter.china@catalent.com
- 公司地址：上班地址：长安镇