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Quality Assurance Specialist I

Employer
Mammoth Biosciences
Location
Brisbane, CA
Start date
May 26, 2022

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Discipline
Clinical, Clinical Medicine, Quality
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Job Details

OPPORTUNITY
The Quality Assurance Specialist I plays a critical role in executing the Mammoth quality management system (QMS) processes. This individual works closely with Mammoth employees to ensure SOPs (Standard Operating Procedures) are followed in accordance with FDA 21 CFR 820 and other applicable standards. The QA Specialist 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 audits

REQUIRED QUALIFICATIONS
  • 5+ years of industry Quality Assurance experience in the biotech, pharmaceutical, or medical device industry or Bachelor’s Degree with 3+ years experience 
  • 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 Manual

PREFERRED QUALIFICATIONS
  • Bachelor’s Degree in a scientific field, preferably molecular biology or biochemistry 
  • 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, PowerPoint

BENEFITS
  • 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 matching

Mammoth 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
The 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.

Mammoth Biosciences requires that all employees be vaccinated against Covid-19 as a condition of at-will employment, with exceptions for medical or religious reasons in compliance with local, state, and federal law. 

Company

Mammoth Biosciences is a biotechnology company focused on leveraging its proprietary ultracompact CRISPR systems to develop long-term curative therapies, as well as other applications such as decentralized precision diagnostics. Founded by CRISPR pioneer and Nobel laureate Jennifer Doudna and Trevor Martin, Janice Chen, and Lucas Harrington, the company’s ultracompact proteins are designed to enable in vivo gene editing in difficult to reach tissues utilizing both nuclease applications and new editing modalities beyond double stranded breaks, including base editing, gene writing, and epigenetic editing. The company is building out its pipeline of potential in vivo gene editing therapeutics and capabilities and has partnerships with leading pharmaceutical and biotechnology companies to broaden the reach of its innovative and proprietary technology. Mammoth’s deep science and industry experience, along with a robust and differentiated intellectual property portfolio, have enabled the company to further its mission to transform the lives of patients and deliver on the full promise of CRISPR technologies.

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Company info
Website
Phone
(650) 294-8583
Location
South San Francisco
CA
94080
United States

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