QA Specialist at Mammoth Biosciences
South San Francisco, CA, US
Mammoth Biosciences is harnessing the diversity of nature to power the next-generation of CRISPR products. Through the discovery and development of novel CRISPR systems, the company is enabling the full potential of its platform to read and write the code of life. By leveraging its internal research and development and exclusive licensing to patents related to Cas12, Cas13, Cas14 and CasPhi, Mammoth Biosciences can provide enhanced diagnostics and genome editing for life science research, healthcare, agriculture, biodefense and more. Mammoth is democratizing disease detection with easy and affordable point-of-care tests that allow real-time and simultaneous detection of multiple conditions, along with high-throughput tests that allow for unprecedented testing volume. Further, the company is transforming disease treatment with its proprietary micro-sized CRISPR proteins that enable new editing and delivery options. Based in San Francisco, Mammoth Biosciences is co-founded by CRISPR pioneer Jennifer Doudna and principal founders Trevor Martin, Janice Chen, and Lucas Harrington. The firm is backed by top institutional investors including Decheng, Mayfield, NFX, and 8VC, and leading individual investors including Brook Byers, Tim Cook, Bob Nelsen, and Jeff Huber.
The QA Associate is responsible for working with design and development colleagues to review and approve all design history file (DHF) and device manufacturing record (DMR) documents to ensure all applicable quality management system (QMS) requirements are met for each document. The QA Associate will be an administrator of the QMS document management system. The QA Associate will be a champion of the company’s QA function and QMS system and assist in its development and its updating when necessary. This role will also assist in designing, developing, and improving the QMS. The QA Associate will work with QA leadership and other stakeholders within the company to develop a system for centralized quality-related data collection and analysis to drive continuous improvement.
- Assist QA Leadership with the design and implementation of the company’s QA function and the QMS
- Assist with the design, development, approval, and implementation Design Control Quality System’s SOPs, forms, and work instructions.
- Review and approve reports, protocols, and documents that will be filed in the DHFs and DMRs for the company’s products.
- Participate in the company’s QMS training efforts.
- Perform and review/approve documents that will be filed in the company’s DHFs and DMRs.
- Work effectively and influence multiple functions (R&D, Operations, Product/Program, Regulatory, Supply Chain, Medical, etc.) to ensure Quality expectations are met
- Assist in ensuring that the company’s QMS is in compliance with all applicable sections of 21CFR Part 820 and ISO 13485.
- Work with product development teams to assess design changes from a systems perspective, identifying risks, delivering design mitigations and evaluating the effectiveness of the risk control measures
- Assist QA and company leadership during internal and external regulatory inspections and manage all inspections and audits.
- Bachelor’s Degree in a scientific field, preferably molecular biology or biochemistry
- 3 years of QA experience in the medical device or combination products industry
- Experience and understanding of design, development, verification and validation, design transfer and manufacturing processes and how they are improved and affected by a company’s QMS.
- Working knowledge and understanding of regulations 21CFR 820 and ISO 13485
- Must be comfortable working in a biohazard environment, and complying with safety policies and standards outlined in the Safety Manual
- Ability to manage multiple conflicting priorities
- Experience with Risk Assessment (ISO 14971, ICHQ 9), ASTM standards and other ICH guidance
- Experience working with an IVD
- Demonstrated ability to train and coach employees with little quality experience
- Experience in both large and start-up corporate cultures
- Excellent verbal, written, communication and proficient computer skills, specifically with statistical software and Microsoft Office Suite including Word, Excel, PowerPoint
- Competitive salary with equity
- Company-paid health/vision/dental benefits
- Unlimited vacation and generous sick time
- Free breakfast/lunch/dinner/barista
- Free gym
- Public transportation commuter subsidy
- 401(k) matching