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.
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