Laboratory Operations Specialist

Company: Ginkgo Bioworks, Inc.
Location: Boston
Posted on: February 25, 2021

Job Description:

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 a highly motivated and detail-oriented Laboratory Operations Specialist to maintain and improve CLIA compliance for all our relevant laboratory equipment. Reporting directly to our Laboratory Operations Manager, you will be responsible for coordinating equipment SOPs, log books, monitoring systems, contracts, service, and maintaining equipment records for all CLIA spaces. Working closely with the Quality Committee and both the Lab and Service Managers to ensure compliance, this role will be critical to the efficient and effective service of our CLIA environment. Responsibilities

• Manage all CLIA equipment needs, including creating and maintaining CLIA equipment inventory, SOPs, and associated documentation for maintenance and general CLIA record keeping
• Work with research teams to establish cleaning and maintenance procedures
• Coordinate with Lab and Service Managers to maintain up to date contracts and reports for CLIA certified equipment, notifying team with equipment onboarding and service needs
• Collaborate with Ginkgo Software and research teams to maintain Batch Records and ensure compliance of data tracking
• Work with Inventory team on intake of reagents
• Maintain and monitor Log Books and sensor system for tracking, confirming that routine cleaning and maintenance has been completed by research teams
• Serve as a member of the Quality Committee by supporting inspection readiness activities, including operational auditing, and ensuring compliance with Ginkgo's procedures and regulatory requirements
• Participate in change management and communication with end users relating to regulated equipment Desired Experience and Capabilities
  • Bachelor's degree in an engineering, scientific or related field
  • 2-5 years of experience in a regulatory space (CLIA, GMP, ISO, etc.)
  • Experience within an R&D laboratory environment
  • Excellent customer service and vendor management skills
  • Proficiency with Smartsheets, MS Project, and Microsoft Office Suite; experience with MediaLab preferred
  • Ability to self-evaluate work for accuracy and completeness
  • Exceptional time management, project management, and organization of detail
  • Strong verbal and written communication skills 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, equality, 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, 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.

Keywords: Ginkgo Bioworks, Inc., Boston , Laboratory Operations Specialist, Healthcare , Boston, Massachusetts