Senior Quality Systems Specialist
IT, Quality Assurance
South San Francisco, CA, USA
Posted on Saturday, January 13, 2024
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.
- Responsible for administrative controls, system configurations, periodic system upgrades and continuous improvement efforts of the eQMS, as needed
- Maintain and improve quality system procedures and programs including training programs, document control, data integrity, supplier quality management and change control
- Manage the periodic review program of the eQMS
- Coordinate employee training; including, employee onboarding to the QMS, daily training tasks within the eQMS, training plans, and training content, etc.
- Coordinate document control processes within the eQMS, including reviewing document formatting, periodic reviews of documents, training authors and approvers to use the system, etc.
- Coordinate supplier qualification efforts for assigned suppliers; including, driving the processes within the eQMS such as requesting and reviewing supplier questionnaires, performing supplier risk management, periodic review of suppliers, supplier audits, supplier corrective actions (SCARS), etc.
- Coordinate change control processes, routing change requests for evaluation, following up on open change controls, hosting change control review board meetings, etc.
- Support internal and external audits and client inspections, as needed
- Develop quality system metrics for training program, document control, supplier quality and change control to track compliance, productivity and effectiveness to be presented during the Quality Management Review
- Establish and promote an environment that supports the Quality Policy, Data Integrity and Quality System.
- Bachelor's degree or higher in a relevant scientific discipline - Biotechnology, Biology, Biochemistry, or Chemistry
- 5+ years experience in a GMP environment
- Strong technical knowledge of cGMP regulations and eQMS systems
- Strong working knowledge of quality systems and regulatory requirements including 21 CFR Part 11/210/211, TrackWise Digital experience preferred
- Strong understanding of regulatory inspection and knowledge of their requirements
- Ability to build strong working relationships with cross-functional departments
- Excellent interpersonal, verbal, and written communication skills
- Comfortability in a fast-paced environment with minimal direction and able to adjust to a dynamic work environment
- Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset
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.