Total Quality Senior Specialist contributes to the development, implementation, administration and measurement of total quality management programs, including Six Sigma initiatives. Provides expertise to cross functional teams to facilitate total quality methods, training, tool development, and logistical support. Being a Total Quality Senior Specialist coordinates with production, operations, customer service and other functions to implement programs. Typically requires a bachelor's degree. Additionally, Total Quality Senior Specialist typically reports to a manager. The Total Quality Senior Specialist work is highly independent. May assume a team lead role for the work group. A specialist on complex technical and business matters. To be a Total Quality Senior Specialist typically requires 7+ years of related experience. (Copyright 2024 Salary.com)
Position Summary
We are seeking an innovative and highly motivated individual to join us as the Senior Quality Systems Specialist at our facility located in South San Francisco, CA. You will be responsible for maintaining the Quality System within the requirements of FDA’s GMP regulations.
The primary focus of this position will be to manage the day to day activities of the eQMS including document control, training, supplier quality management and change control.
This is a multidisciplinary role & this individual will further interface across many parts of the company to develop novel products used in the cell therapy and gene therapy world. This role will be a hands-on resource and will be required to be on-site (with certain instances where work-from-home is permitted).
Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.
This is Cellares
Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.
The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.
Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.
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