We are seeking candidates interested in working for an exciting start-up company located in San Francisco. This is an ideal opportunity for individuals who thrive in a changing environment and enjoy supporting and delivering world-class products that meet both external and internal customer needs.
This is a role for someone who craves a challenge balanced by the desire to be accountable for delivering high quality products for Twist. It is both a strategic and a tactical position. Those that do not want to get their hands dirty should not apply.
The QC Specialist will be responsible for the implementation and continuous improvement of QC methods in the production laboratory. He/she will work closely with the operations team to monitor the quality of Twist DNA products utilizing quantitative measurements, fragment analysis, NGS sequencing, etc. The successful candidate must have a demonstrated capability of making data driven decisions in a high throughput environment to assure that all products processed, packaged, stored, and distributed are manufactured in compliance with all Regulatory, Customer, and Twist requirements. In this position you will report to the Senior Manager of QC.
Job Duties include but are not limited to:
- Monitor QC data that is generated by the factory on a daily basis
- Ensure data is properly managed and sent through the data pipe in a timely manner
- Train manufacturing operators on SOP's for data processing and analysis
- Troubleshoot QC issues
- Establish quality and reliability standards of materials, intermediates, products and processes based on in-house capabilities and customer requirements with other members of management from Production, R&D, Marketing and Engineering teams
- Collaborate with the R&D team to transfer methods and procedures that establish and assure robust protocols for intermediates, products and processes
- Work with stakeholders to set corporate quality standards including product quality documentation, quality assurance policies, procedures protocols (SOPs)
- Setting, owning and documenting process improvement activities
- Preparation of product and process quality reports by collecting, analyzing, and summarizing information and trends
- Assuring manufacturing compliance activities meet GMP/ISO (not implemented yet) and other requirements, and all manufacturing practices and record keeping are in full compliance with the applicable regulatory agency requirements
- Preparing reports, track data and present trends and analysis
- Implementation of statistics, statistical analysis tools to build quality metrics for development and manufacturing processes