QC专员
安倍医疗器械贸易（上海）有限公司
- 公司规模：50-150人
- 公司性质：外资(欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2015-06-30
- 工作地点：上海-浦东新区
- 招聘人数：1
- 学历要求：本科
- 语言要求：英语熟练
- 职位月薪：面议
- 职位类别：质量检验员/测试员
职位描述
Position Summary:
Responsible for performing the raw material and finished product testing. Interacts with other departments to expedite material through the system for release into inventory for timely sale to the customer. Maintains required documentation in a timely manner. Provides feedback and information on product performance to Technical Service, Manufacturing, Inventory Control, and Shipping personnel to allow appropriate planning and corrective action where required. Has an in-depth knowledge of the MP Biomedicals Quality System and both ISO 13485:2003 and 21 CFR 820 quality systems regulations.
Duties:
1, Product Availability
* Perform finished product and raw material testing.
* Conduct lab procedures such as IR, mp, Ph, UV, Optical rotations, Loss on drying, etc
* Interact with Manufacturing, Physical Production, Inventory Control, Assembly, and Shipping to give and receive information and updates concerning product status.
* Reprioritize when required. Keep Director of QC up to date on critical issues and product status.
* Work with other QC staff to maintain efficiency.
* Complete all required documentation for product release in a timely manner, assuring availability. Do not allow release until all documentation is complete and reviewed.
* Where required, document release of non-conforming material via the MRB system. Write and assist in writing specific MRB release documentation for review by management.
* Keep minimal to no back orders.
2. Product Support
* Perform stability and re-assay work as required to confirm expiration dating and product performance throughout shelf life.
* Extend dating on all products where possible to allow more efficient manufacture. Document all work and make any changes via the QER system.
* Interact with Inventory Control on date extension requests to reduce discards.
* Confirm results where required and document all work as required by Design Control regulations and as per approved validation plans.
* Interact with Technical Services to perform assay work for troubleshooting or confirming customer complaints.
* Provide results in a neat and organized format, in a timely manner.
3. Quality Systems
* Conform to internal specifications and procedures as well as the Quality Systems Regulations as defined in 21 CFR 820.
* Maintain scheduled calibrations and validations for lab equipment, including pipettes. Perform required calibrations according to procedure within one week of due date.
* Review Systems, Procedures, and specifications as used.
* Make improvements/changes as required, utilizing the QER System after appropriate data review or validation.
Requirements:
* Bachelor’s in Chemistry, Masters in Chemistry preferred
* Prior experience with lab procedures such as IR, mp, Hh, UV-vis, Optical rotation, Loss on drying, etc.
Responsible for performing the raw material and finished product testing. Interacts with other departments to expedite material through the system for release into inventory for timely sale to the customer. Maintains required documentation in a timely manner. Provides feedback and information on product performance to Technical Service, Manufacturing, Inventory Control, and Shipping personnel to allow appropriate planning and corrective action where required. Has an in-depth knowledge of the MP Biomedicals Quality System and both ISO 13485:2003 and 21 CFR 820 quality systems regulations.
Duties:
1, Product Availability
* Perform finished product and raw material testing.
* Conduct lab procedures such as IR, mp, Ph, UV, Optical rotations, Loss on drying, etc
* Interact with Manufacturing, Physical Production, Inventory Control, Assembly, and Shipping to give and receive information and updates concerning product status.
* Reprioritize when required. Keep Director of QC up to date on critical issues and product status.
* Work with other QC staff to maintain efficiency.
* Complete all required documentation for product release in a timely manner, assuring availability. Do not allow release until all documentation is complete and reviewed.
* Where required, document release of non-conforming material via the MRB system. Write and assist in writing specific MRB release documentation for review by management.
* Keep minimal to no back orders.
2. Product Support
* Perform stability and re-assay work as required to confirm expiration dating and product performance throughout shelf life.
* Extend dating on all products where possible to allow more efficient manufacture. Document all work and make any changes via the QER system.
* Interact with Inventory Control on date extension requests to reduce discards.
* Confirm results where required and document all work as required by Design Control regulations and as per approved validation plans.
* Interact with Technical Services to perform assay work for troubleshooting or confirming customer complaints.
* Provide results in a neat and organized format, in a timely manner.
3. Quality Systems
* Conform to internal specifications and procedures as well as the Quality Systems Regulations as defined in 21 CFR 820.
* Maintain scheduled calibrations and validations for lab equipment, including pipettes. Perform required calibrations according to procedure within one week of due date.
* Review Systems, Procedures, and specifications as used.
* Make improvements/changes as required, utilizing the QER System after appropriate data review or validation.
Requirements:
* Bachelor’s in Chemistry, Masters in Chemistry preferred
* Prior experience with lab procedures such as IR, mp, Hh, UV-vis, Optical rotation, Loss on drying, etc.
公司介绍
MP Biomedicals是全球少数能够全面提供生命科学、精细化学及临床诊断类产品的公司之一。目前生产和销售的产品超过5.5万种，在生命科学及体外诊断领域品牌认可度高，主要产品已通过欧盟CE、中国CFDA、美国FDA等卫生监管部门的认证。
经过50多年的发展，MP已经形成了布局全球的销售网络和渠道。MP 总部位于美国加利福尼亚州，在中国、新加坡、澳大利亚、法国等全球14个国家设有16家子公司。2016 年，MP被中节能万润股份有限公司全资收购，成为旗下子公司。
生命科学业务主要产品包括分子生物学产品、细胞生物学、免疫化学产品、生物化学产品以及精细化学品，主要用于基因组学、蛋白质组学、代谢组学、药物开发、食品安全检测及科学探索的其他领域
体外诊断业务主要产品包括***诊断试剂、快速诊断试剂、免疫诊断试剂及配套仪器，主要用于艾滋病、各型肝炎、癌症、心脑血管疾病、登革热等疾病的诊断及毒品滥用、内分泌水平的检测
经过50多年的发展，MP已经形成了布局全球的销售网络和渠道。MP 总部位于美国加利福尼亚州，在中国、新加坡、澳大利亚、法国等全球14个国家设有16家子公司。2016 年，MP被中节能万润股份有限公司全资收购，成为旗下子公司。
生命科学业务主要产品包括分子生物学产品、细胞生物学、免疫化学产品、生物化学产品以及精细化学品，主要用于基因组学、蛋白质组学、代谢组学、药物开发、食品安全检测及科学探索的其他领域
体外诊断业务主要产品包括***诊断试剂、快速诊断试剂、免疫诊断试剂及配套仪器，主要用于艾滋病、各型肝炎、癌症、心脑血管疾病、登革热等疾病的诊断及毒品滥用、内分泌水平的检测
联系方式
- 公司地址：北京海淀区首体南路6号新世纪日航饭店写字楼