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Associate, Lab Quality Control 37 views

Boston, MA

Our mission is to make biology easier to engineer. Ginkgo is constructing, editing, and redesigning the living world in order to answer the globe’s growing challenges in health, energy, food, materials, and more. Our bioengineers make use of an in-house automated foundry for designing and building new organisms. Today, our Foundry is developing over 40 different organisms to make different products across multiple industries.
We’re looking for driven Quality Engineers to provide support for Ginkgo’s Foundry.  Working directly with our Operations Teams, you will assist with identifying and troubleshooting any issues with our services.  You will collaborate with internal and external stakeholders to suggest system improvements and enhance quality systems.  With your excellent problem-solving skills, you will be a key contributor in keeping our operations running smoothly.
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Responsibilities

  • Driving quality oversight with key metrics and developing tools for quality control management.
  • Lead the design and build-out of quality management workflows into Foundry services such as root cause analysis, corrective action and preventive action (CAPA) and other continuous quality improvement processes.
  • Escalating critical quality issues to quality management, and working with teams to mitigate risks.
  • Sharing intel/trending/signaling from Foundry level quality issues to enable better decision making and risk mitigation.
  • Sharing case studies/lessons learned from QA activities with teams to minimize recurrence of similar issues.
  • Administer Document control system. Update or write new SOPs as required and complete chain of approval for document review. 
  • Responsible for the scheduling and carrying out the Quality related training program for new hires and the team.
  • Facilitate and support internal audits and external audits from regulatory bodies or customers/partners.
  • Participate and support other quality team initiatives and ongoing activities such as reagent qualification, instrumentation validation and batch record reviews.
  • Work Environment

  • May include incidental exposure to hazards associated with:
  • Close proximity to moving mechanical parts and electrical components.Chemicals such as reagents, carcinogens, corrosives, flammables and fumes.
  • Microorganisms which can include fungus, bacteria, viruses, etc.
  • Functions may require use of protective gear such as eye protection, gloves, and fluid-resistant coats.
  • Desired Experience

  • A Bachelor’s degree or equivalent in science, engineering, or related field.
  • Minimum 2 year of experience in laboratories, medical devices, or life sciences industries.
  • Working experience with an organization that has an established QMS is preferred. 
  • Previous experience in document control systems and technical writing.
  • Excellent interpersonal, verbal, and written communication skills. 
  • Independent worker, self-starter with strong organizational and planning skills.
  • Willing to accept temporary responsibilities outside of the initial job description.
  • To learn more about Ginkgo, check out some recent press:
    We also feel that it’s important to point out the obvious here – there’s a serious lack of diversity in our industry, and that needs to change. Our goal is to help drive that change. Ginkgo is deeply committed to diversity, equity, and inclusion in all of its practices, especially when it comes to growing our team. Our culture promotes inclusion and embraces how rewarding it is to work with people from all walks of life.  
    We’re developing a powerful biological engineering platform, so we must remain mindful of the many ways our technology can – and will – impact people around the world. We care about how our platform is used, and having a diverse team to build it gives us the best chance that it’s something we’ll be proud of as it continues to grow. Therefore, it’s critical that we incorporate the diverse voices and visions of all those who play a role in the future of biology.
    It is the policy of Ginkgo Bioworks to provide equal employment opportunities to all employees and employment applicants.

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    Company Information
    • Active Jobs 115 Jobs
    • Company Address 27 Drydock Avenue, 8th Floor Boston, MA 02210
    • City Boston
    • Location Massachusetts
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