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Senior Lab Analyst

4 months ago

Shanghai, China Straumann Group Full time

Position Summary

Manufacturing and operations are at the centre of our business, ensuring the production of our products and equipment that meet the needs of our customers and their patients. A career in manufacturing and operations requires a unique combination of technical expertise, attention to detail, and the ability to work collaboratively with a variety of different people. 

Our team manages the production process, ensuring quality control measures are in place, and implementing innovative and efficient systems to ensure timely delivery of products to customers. If you have a passion for precision, a strong work ethic, and are ready to make a real impact on people's lives join us at Straumann Group and unlock your true potential. 

This role is responsible for the routine test items of the Microbiology Laboratory group, as a part of the Quality Department for our manufacturing facility. 

This position is based in our Shanghai Campus, reports directly to the Lab Manager. 

Job Responsibilities 

Perform Bioburden testing and Bacterial endotoxin test of In-Process and Final products. 

进行中间品及成品微生物负载测试和细菌内毒素测试 

Perform purified water system testing and clean area environmental monitoring. 

纯化水系统检测和洁净区环境监测。 

Assist in the development and maintenance of quality documentation including standard operating procedures, test methods, work instructions, risk assessments, technical/validation protocols and reports, etc.

协助开发和维护质量文件，包括标准操作程序、测试方法、工作指导书、风险评估、技术/验证协议和报告等。 

Assist in the establishment of BSL-2 laboratory. 

协助生物二级实验室的建设。 

Accurately assess testing data to ensure product specifications can meet requirement, according to current cGMP and site SOPs 

依据GMP及工厂标准作业指导，对测试数据进行评估以确保产品满足标准并对按要求整理记录。 

Support Calibration and maintenance of laboratory equipment. 

支持实验室设备进行计量及维护。 

Help to reach department goals and objectives through collaboration and influence. 

协助团队完成目标 

Problem solving – has a working knowledge of available tools related to job function and incorporates the different databases, applications, personal knowledge, and individual experiences when necessary. 

熟悉工作中常用的问题解决工具，能够对不同的数据、应用程序、专业知识及个人经验进行整合以解决问题。 

Provide guidance and/or training to high performing technicians and new hires as needed. 

对新的技术员进行指导和培训。 

Qualifications: 
 

Expertise in processes such as (but not limited to) aseptic technique, data analysis, microorganism identification, Bioburden testing and Environmental Monitoring (including Purified water testing, viable and total particulate air sampling) 

在无菌技术、数据分析、微生物鉴定、生物负载测试和环境监测(包括纯化水测试、微生物和粒子采样)等方面具有专业知识。 

Moderate knowledge of GMP, ISO13485, ISO 14644, GB1997. GB18280 and 21CFR 

具备一定的GMP、ISO13485、ISO14644、GB1997/GB18280和21CFR知识 

Ability to manage troubleshooting of potential complex laboratory issues and provide strong reasoning skills in support of root cause investigations. 

能够管理解决潜在的复杂实验室问题，并提供强大的推理能力，以支持根本原因调查。 

Verbal/written proficiency in English is required. 

需要良好的英语沟通和书写能力 

Knowledge of the Chinese Pharmacopeia with respect to EM and PW related chapters is required. 

了解药典中与环境监测和水系统测试相关章节。 

At least 5 years’ experience working in a similar role in the medical diagnostic/medical device/pharmaceutical industry, FDA-regulated laboratory industry. 

至少5年以上医疗诊断、医疗器械、制药或FDA监管的实验室相关岗位工作经验。 

Bachelor’s Degree (or equivalent degree) with a discipline in Biology, Chemistry, Biochemistry, Biotechnology, Microbiology, Molecular Biology or Medical Technology is required. 

生物学、化学、生化学、生物技术、微生物学、分子生物学、医疗技术相关专业本科。 

About Straumann

The Straumann Group (SIX: STMN) is a global leader in tooth replacement and orthodontic solutions that restore smiles and confidence. It unites global and international brands that stand for excellence, innovation and quality in replacement, corrective and digital dentistry, including Anthogyr, ClearCorrect, Dental Wings, Medentika, Neodent, NUVO, Straumann and other fully/partly owned companies and partners. In collaboration with leading clinics, institutes and universities, the Group researches, develops, manufactures and supplies dental implants, instruments, CADCAM prosthetics, biomaterials and digital solutions for use in tooth replacement and restoration or to prevent tooth loss.

Headquartered in Basel, Switzerland, the Group currently employs more than 7300 people worldwide and its products, solutions and services are available in more than 100 countries through a broad network of distribution subsidiaries and partners. 

For more information, please visit:



Equal Opportunity and Affirmative Action Employer (US applicants only)
Straumann Group is an equal opportunity employer and will not discriminate against any employee or applicant for employment on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national origin, age, veteran status, or disability unrelated to job requirements. Straumann Group will take affirmative action to ensure that qualified applicants are employed and that employees are treated without regard to their race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran and disability status. In compliance with U.S. Department of Labor Executive Order 11246, Section 503 of the Rehabilitation Act, and Section 4212 of the Vietnam Era Readjustment Assistance Act, Straumann Group has developed and maintains an affirmative action program and plan.

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