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Quality Assurance Specialist I/II

Company: Mammoth Biosciences
Location: Brisbane
Posted on: May 16, 2022

Job Description:

OPPORTUNITYThe Quality Assurance Specialist plays a critical role in executing the Mammoth quality management system (QMS) processes. This individual works closely with Mammoth employees to ensure SOPs are followed in accordance with FDA 21 CFR 820 and other applicable standards. The QA associate works closely with subject matter experts to ensure all processes are followed and records meet applicable requirements. This is an excellent development opportunity for those who want to learn new skills in quality and start their career supporting cutting-edge CRISPR technologies. -KEY RESPONSIBILITIES

  • Assist Quality Leadership with the design and implementation of the company's QA function and the QMS
  • Participate in the company's QMS training efforts and the creation and maintenance of training curriculum and roles
  • Work with product development teams to assess proposed design changes, evaluate the impact from a systems perspective, and ensure proper documentation of all activities related to the change
  • Assist scientists with maintaining electronic laboratory notebooks and data records in accordance with Good Documentation Practices
  • Work effectively across 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 13485:2016
  • Assist QA and company leadership during internal and external regulatory inspections and manage all inspections and auditsREQUIRED QUALIFICATIONS
    • Bachelor's Degree in a scientific field, preferably molecular biology or biochemistry
    • 3+years of Quality Assurance experience in the biotech, pharmaceutical, or medical device 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 13485:2016
    • Must be comfortable working in a biohazard environment, and complying with safety policies and standards outlined in the Safety ManualPREFERRED QUALIFICATIONS
      • 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
      • Verbal, written, communication and proficient computer skills, specifically with statistical software and Microsoft Office Suite including Word, Excel, PowerPointBENEFITS
        • Company-paid health/vision/dental benefits
        • Unlimited vacation and generous sick time
        • Company-sponsored meals and snacks
        • Wellness, caregiver and ergonomics benefits
        • 401(k) with company matchingMammoth Biosciences is harnessing the diversity of life to power the next generation of CRISPR products. Through the discovery and engineering of novel CRISPR systems, the company is enabling the full potential of its platform to read and write the code of life. Mammoth aims to develop permanent genetic cures through best-in-class in vivo and ex vivo therapies and to democratize disease detection with on-demand diagnostics. Mammoth can provide enhanced diagnostics and genome editing for life science research, healthcare, agriculture, biodefense and more. Based in the San Francisco Bay Area, Mammoth Biosciences is co-founded by CRISPR pioneer and Nobel Laureate Jennifer Doudna and Trevor Martin, Janice Chen, and Lucas Harrington. The firm is backed by top institutional investors including Redmile Group, Foresite Capital, Senator Investment Group, Sixth Street, Decheng, Mayfield, NFX, and 8VC, along with leading individual investors including Brook Byers, Tim Cook, and Jeff Huber.TEAM DxThe Diagnostics team is advancing our CRISPR-based DETECTR - platform to address unmet needs across the continuum of testing. From laboratories to the home, our mission is to democratize diagnostics with CRISPR. -It is our policy and intent to provide equal opportunity to all persons without regard to race, color, religion, political affiliation, sex/gender (including gender expression/identity, pregnancy, childbirth and related medical conditions), marital status, registered domestic partner status, sexual orientation, age, ancestry, national origin, veteran status, disability, medical condition, genetic characteristics, and/or any other basis protected by law. - This policy covers all facets of employment including, but not limited to: recruitment, selection, placement, promotions, transfers, demotions, terminations, training, and compensation.

Keywords: Mammoth Biosciences, San Francisco , Quality Assurance Specialist I/II, Other , Brisbane, California

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