Quality Control Supervisor

Job description

Twist Bioscience is hiring a Quality Control Supervisor at our Wilsonville facility. You will lead daily QC operations, oversee product releases, and drive continuous improvement across our molecular biology testing methods. In this hands-on role, you will build and mentor a team of QC associates while working cross-functionally with R&D, Operations, and Engineering to maintain robust ISO 13485 and GMP compliance. **What You’ll Be Doing** - **Operations & Leadership:** Lead, train, and mentor a high-performing team of Quality Control associates. Monitor and manage daily QC product releases generated by the factory, ensuring proper execution in a timely manner. - **Method Implementation & Improvement:** Implement, maintain, and continuously improve QC methods in the production laboratory. Assist with documenting process improvement activities. - **Standards & Cross-Functional Alignment:** Establish quality and reliability standards for materials, intermediates, products, and processes alongside Production, R&D, Marketing, and Engineering teams. Collaborate with stakeholders to set corporate quality standards, documentation, and SOPs. - **Technology & Method Transfer:** Partner with R&D to transfer new methods and procedures into production, establishing robust protocols. Work with automated robotic platforms and LIMS systems for daily tracking and data analysis. - **Troubleshooting & Metrics:** Proactively identify production and laboratory issues; troubleshoot complex problems across lab techniques, protocols, product handling, and equipment. Implement statistical analysis tools to build quality metrics for development and manufacturing processes. - **Reporting & Compliance:** Prepare, track, and present product and process quality reports and trend analyses. Train manufacturing operators on SOPs for data processing. Ensure full compliance with GMP, ISO 13485, and applicable regulatory agency requirements. ### **What You’ll Bring to the Team** - **Education:** BS in Biochemistry, Chemistry, Molecular Biology, or a related scientific discipline. - **Experience:** 1+ years of industrial experience in Quality Control or Operations within a regulated manufacturing environment. - **Quality & Regulatory Knowledge:** Strong understanding of Quality Control and Quality Assurance principles, including ISO 13485 and GMP standards. - **Laboratory & Technical Expertise:** Demonstrated knowledge of molecular biology techniques (e.g., PCR, Cloning, Sequencing) and analytical tools (e.g., Spectroscopy, Gel Electrophoresis). - **Systems Proficiency:** Hands-on experience working with automated robotic systems and LIMS environments. - **Core Skills:** Proven ability to troubleshoot complex technical problems, apply statistical analysis, and demonstrate strong verbal and written communication skills.