Quality Assurance Associate

Ginkgo Bioworks is a publicly traded (NYSE: $DNA), high-growth biotechnology company based in Boston’s Seaport District, that is redesigning the living world to solve some of the globe’s growing challenges in health, energy, food, material, and more. Our mission to “make biology easier to engineer” is poised to disrupt multiple industries by leveraging our innovative data, automation, and scale capabilities in biological engineering.

Ginkgo believes that if we are to grow a thriving, sustainable bioeconomy, we must also grow a new market in biosecurity. Our biosecurity and public health initiative, Concentric by Ginkgo, launched a nationwide emergency response to the COVID-19 pandemic, providing end-to-end pathogen monitoring services to schools, communities, and travelers. As we continue to scale Concentric, our work is also evolving into new and exciting directions, from global expansion to the integration of new technologies and capabilities, including our Traveler-Based Genomic Surveillance Plan with the CDC.

Responsibilities

• Administer customer non-compliance and quality complaints. Analyze information in order to help identify the root causes of problems occurring at the operational level.
• Follow-up on complaint root cause findings to ensure that appropriate actions have been taken and have adequately resolved the issues identified.
• Perform spot check audits and inspections as needed, document and communicate findings to the Manager of Compliance and Quality Assurance as well as additional stakeholders.
• Generate, implement and/or review validation protocols, summary reports, SOPs, specifications and other applicable quality documentation in the company’s Quality Management System.
• Facilitate and coordinate training of new and existing team members, prepare training materials as necessary.
• Generate and review metrics to support quality process improvement activities.
• Identify opportunities for continuous improvement throughout the business unit
• Detail oriented with strong verbal and written communication skills are essential, as well as follow-up and follow through skills.
• Support quality management systems implementation within the organization.
• Interact regularly with teams and communicate clearly and effectively across multiple departments.
• Other duties as assigned by management

Minimum Requirements

• Bachelor’s degree in biology, engineering, or science-related field preferred
• Minimum 2 yrs QA experience (clinical laboratory QA is a plus)
• Experience maintaining high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs.
• Ability to work independently with a high level of initiative
• Ability to manage multiple priorities and to meet deadlines
• Excellent knowledge of Google Suite

Preferred Capabilities and Experience

• Hands-on, team-oriented philosophy with commitment to business improvement processes
• Demonstrated project management experience preferred
• Experience with ZenDesk and/or Qualio is a plus