Quality Control Lead — ISO 13485 & GMP

TWIST BIOSCIENCE; Wilsonville (OR); On-site; USD 70,000 - 100,000; Full time

Job summary

Twist Bioscience in Wilsonville, Oregon is seeking a Quality Control Supervisor to 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 collaborating with R&D, Operations, and Engineering to maintain robust ISO 13485 and GMP compliance, and to implement data-driven quality metrics using LIMS and automated platforms.

Qualifications

• BS in Biochemistry, Chemistry, or Molecular Biology.
• 1+ year of industrial experience in QC or operations within a regulated manufacturing environment.
• Strong understanding of ISO 13485 and GMP standards.
• Demonstrated knowledge of molecular biology techniques and analytical tools.
• Hands-on experience with automated robotic systems and LIMS environments.

Responsibilities

• Lead, train, and mentor a team of Quality Control associates and manage daily QC product releases.
• Implement, maintain, and improve QC methods in the production laboratory.
• Ensure GMP, ISO 13485 compliance and regulatory requirements.
• Transfer new methods with R&D and work with LIMS systems for tracking and data analysis.
• Identify production and laboratory issues; troubleshoot and build quality metrics through statistical analysis.

Skills

Quality control

Leadership

GMP compliance

ISO 13485

Data analysis

Education

BS in Biochemistry, Chemistry, or Molecular Biology

Tools

LIMS

Robotics

Job description

Twist Bioscience in Wilsonville, Oregon is seeking a Quality Control Supervisor to 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 collaborating with R&D, Operations, and Engineering to maintain robust ISO 13485 and GMP compliance, and to implement data-driven quality metrics using LIMS and automated platforms.