QA Associate II

The QA Associate II is responsible for ensuring the accurate, compliant, and timely release of Twist’s synthetic biology products, with a primary focus on batch record review, raw material and lot release, and quality event support. Working in an ISO 13485 manufacturing environment, this role partners closely with production, equipment, and subject matter experts to investigate quality events, support root cause analysis, and keep documentation and processes inspection-ready. A strong working knowledge of cGMP and IVD regulatory requirements, along with high attention to detail and clear communication, is critical to success in this role. This is a great opportunity for a quality professional who enjoys hands-on, on-site work and wants to grow their impact by mentoring peers and supporting internal and external audits.

Knowledge & Application

• Ensures the accurate and safe release of various synthetic biology products in accordance with company and/or client procedures and requirements.
• Ensures and promotes compliance with applicable ISO, cGMP, IVD Regulations, and company and client SOPs.
• Authors and reviews relevant SOPs, batch records, labels and other documents.
• Manufacturing Batch Record review, control, release, including label verification.
• Materials management (including Raw Material Release)