QA Associate II

Twist Bioscience seeks a QA Associate II to oversee batch record review, raw material release, and quality event investigations for synthetic biology products in an ISO 13485 environment. The role requires hands-on manufacturing oversight, regulatory compliance expertise, and collaboration with production teams to maintain inspection-ready documentation and processes.

Responsibilities

• Review, control, and release manufacturing batch records with label verification
• Manage raw material release, nonconformance disposition, and quality event investigations
• Collaborate with subject matter experts on root cause analysis and quality event documentation
• Conduct periodic lab walkthroughs, mentor peers on release processes, and support internal/external audits
• Track quality metrics and review IQOQPQs with equipment teams

Requirements

• Bachelor's degree in scientific or engineering field
• 2-3 years medical device, pharmaceutical, or biotech industry experience
• Minimum 2 years Quality Assurance or Regulatory Compliance experience
• Knowledge of cGMP, IVD regulations, ISO 13485, and 21 CFR 820
• Strong written and verbal communication skills
• Analytical and problem-solving capabilities
• Familiarity with Confluence and JIRA applications preferred