长沙招聘

How will you make an impact?

Deliver analytical solution to clients through expertise in biologic specific method qualification and validation strategies while ensuring on-time delivery for projects as well as overseeing, the group activities of instrument qualification, PM and calibration, Stability program, specifications management and working with the laboratories to schedule all types of sample testing.

What will you do?

• Hires, develops, and manages professionals within the Quality Control Technical Services. Provides feedback and coaching, provides opportunities for growth and takes necessary disciplinary actions. Ensures awareness and compliance with Health authority regulations.
• Coordinate/drive customer specific projects within functional area and assigns resources as appropriate. Interfaces with customers to ensure clear and open communication is maintained. Responsible for the capacity forecast model for human and equipment resources and represents the Quality Control organization at site / planning meetings.
• Work with Quality Control Sr. Manager and Quality Leadership to continually seek ways to improve the Quality Culture of the organization and specifically of the Quality Control organization. Approves department budget and initiates cost control measures.
• Ensures adequate training (skills-based, cGMP and Safety) of personnel within department, to support various phases of production both clinical and commercial through highly competent staff.
• Reviews departmental documentation (e.g., Standard Operating Procedures, STPs, Qualification protocols, Specifications etc.). Participates in revisions, providing input, as necessary.
• In charge of QC instrument Qualification, calibration and PM to ensure all instruments are qualified as planned in compliant way before application and maintained as required in routine operation;
• Make sure all necessary reagents, standard references etc. that support testing are well planned, maintained and supplied as business needs required;
• Manage stability system and program to ensure all stability programs are executed in a timely manner as planned and provide data analysis and stability report as required as per cGMP requirement.
• Report appropriate metrics to ensure timelines and turnaround time are on track.
• Work with group leads to set milestone deliveries and ensure adherence to commitments.

  
  

  How will you get here?

  
  

  Education

• Bachelor’s Degree in Life Sciences

Experience

• 7-10 years of experience in a regulated manufacturing, Quality or QC laboratory environment
• 5 years prior supervisory or management experience required.

Knowledge, Skills, Abilities

• Extensive knowledge and exposure to cGMP environment. Audit experience.
• Extensive knowledge of general and specific QC testing principles, as applicable to focus of position (e.g., chemistry, microbiology, biochemistry, bio-assay, etc.).
• Knowledge of testing and associated equipment protocols and requirements and analytical instrumentation including biologic specific methodology.
• Strong interpersonal and communications skills; written and oral.
• Solid understanding of applicable regulatory requirements as it relates to analytical method transfer, microbiological verification, USP, and stability
• Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA
• Oversight of complex functional department, often including junior management levels
• Communicate effectively to peers and all levels of the organization within and outside of department. Interact with external contacts.
• Ability to work cross functionally with members of Quality Control, Operations, and Biologics to meet timelines and objectives in a compliant manner
• Delegates and/or participates in Health Agency/internal audits.

About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.

About Thermo Fisher Scientific China
Thermo Fisher Scientific (China) Co., Ltd has been operating in China for over 35 years. Headquartered in Shanghai, Thermo Fisher Scientific China has branch offices in Beijing, Guangzhou, Hong Kong, Chengdu, Shenyang, Xi’an, Nanjing, Wuhan, Jinan, and Dongguan with around 5,000 employees. Our products mainly include analytical instruments, laboratory equipment, chemical reagents, consumables, software and more; providing comprehensive laboratory solutions and serving customers across various industries.
In order to meet the local needs in China, we have established 8 manufacturing sites in Shanghai, Beijing, Suzhou and Guangzhou respectively. We also have 6 application centers and demo labs across the country which bring world-class technology and products with application development and training services to local customers. Lastly, we have the China Innovation Center in Shanghai and Suzhou, with over 100 scientists & engineers and more than 100 patents. China Innovation Center focuses on research and development supporting key vertical markets and develops products according to local demands with global advanced technologies. We have a nationwide maintenance network and China service training team, including over 2,800 professionals directly providing services for customers.
We are committed to enabling our customers to make the world healthier, cleaner and safer.

赛默飞世尔科技简介
赛默飞世尔科技是科学服务领域的世界领导者。公司年销售额超过300亿美元。
我们的使命是帮助客户使世界更健康、更清洁、更安全。我们帮助客户加速生命科学领域的研究、解决在分析领域所遇到的复杂问题与挑战、促进医疗诊断和治疗的发展、提高实验室生产力。
我们全球超过80,000名赛默飞员工将借助于一系列行业领先的品牌Thermo Scientific、Applied Biosystems、Invitrogen、Fisher Scientific、Unity Lab Services和Patheon，为客户提供领先的创新技术、便捷采购方案和全方位服务。

赛默飞世尔科技中国简介
赛默飞世尔科技进入中国发展已超过35年，在中国的总部设于上海，并在北京、广州、香港、成都、沈阳、西安、南京、武汉、济南、东莞等地设立了分公司，员工人数约为5000名。我们的产品主要包括分析仪器、实验室设备、试剂、耗材和软件等，提供实验室综合解决方案，为各行各业的客户服务。
为了满足中国市场的需求，现有8家工厂分别在上海、北京、苏州和广州等地运营。我们在全国还设立了6个应用开发中心以及示范实验室，将世界级的前沿技术和产品带给中国客户，并提供应用开发与培训等多项服务；位于上海和苏州的中国创新中心，拥有100多位专业研究人员和工程师及100多项专利。创新中心专注于垂直市场的产品研究和开发，结合中国市场的需求和国内外先进技术，研发适合中国用户的技术和产品；我们拥有遍布全国的维修服务网点和特别成立的中国技术培训团队，在全国有超过2800名专业人员直接为客户提供服务。
我们致力于帮助客户使世界更健康、更清洁、更安全。