Sr. QA Specialist at Mammoth Biosciences
South San Francisco, CA, US
COMPANY
Mammoth Biosciences. Inc. 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 and Nobel Prize winner 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. 
 
OPPORTUNITY
The QA Sr. Specialist will work closely with the Director of Quality in the design and implementation of the Mammoth QMS. The Sr. Specialist is responsible for developing critical QMS subsystems that ensure compliance with 21 CFR Part 820 regulations. The Sr. Specialist will be a champion of the company’s QA function and a strong influencer with key stakeholders. The successful candidate will utilize cGMP principles to guide development scientists, project leaders, and commercial leadership in the design and deployment of the highest quality products. The Sr. Specialist will also conduct data trending and analysis to drive continuous improvements to the QMS.  Prior experience in the development and launch of Diagnostic, Medical Device, or Pharmaceutical products is essential.

KEY RESPONSIBILITIES

    • Design, develop, and implementation Design Control Quality System’s SOPs, forms, and work instructions
    • Ensure that the company’s QMS is in compliance with all applicable sections of 21CFR Part 820 and ISO 13485
    • Work closely with key stakeholders to develop, implement, and review dFMEAs in accordance with ISO 14971
    • 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
    • Review and approve reports, protocols, and documents that will be filed in the DHFs and DMRs
    • Develop and Conduct training programs regarding all aspects of the QMS
    • Assist with the development and implementation of Post-Market QMS systems as per 21 CFR Part 803 regulations.
    • Develop and apply Root Cause Analysis tools to identify root causes and propose effective corrective and preventive actions
    • Design, development, and implementation of the Equipment Quality Management (i.e. IOPQ, calibration, PM, etc.)
    • Manage documents within the Document Control System
    • Oversee and enforce Supplier Quality Agreements
    • Conduct  internal and external regulatory inspections and audits.

REQUIRED QUALIFICATIONS

    • Bachelor’s Degree in Engineering or Scientific field
    • 6 years of QA experience in the medical device or combination products industry
    • Experience in design, development, verification and validation, design transfer and manufacturing processes
    • Working knowledge and understanding of Device and Combination products regulations (21CFR 820 and ISO 13485), Risk Assessment (ISO 14971, ICHQ 9), ASTM standards and other ICH guidance
    • Ability to work in a biohazard environment and comply with safety policies and standards 

PREFERRED QUALIFICATIONS

    • Basic understanding of molecular biology 
    • Excellent verbal, written, communication and proficient computer skills, specifically with statistical software and Microsoft Office Suite including Word, Excel, PowerPoint
    • Experience with electronic quality management systems
    • Prior experience in both large and small corporate environments
    • Understanding of CRISPR technology
    • Experience building quality management systems in a startup environment

BENEFITS

    • 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
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