Role OverviewThe QA Associate II is responsible for ensuring the accurate, compliant, and timely release of Twist’s synthetic biology products. 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.
What You Will Do
Ensures the accurate and safe release of various synthetic biology products, authors and reviews relevant SOPs, batch records, labels, and other documents, and collaborates with SMEs to investigate Quality event tickets.
Why It Might Be a Fit
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.
Requirements
- Bachelors degree (or equivalent) in a scientific /engineering related field
- 2-3 years of experience in the medical device/pharmaceutical/biotech industry
- Minimum 2 years of Quality Assurance or Regulatory Compliance (e.g. GCP, cGMP, GLP) experience
- Familiarity with regulatory requirements for IVD Products, ISO 13485, 21CFR820, MDD
- Strong written and verbal communication skills
- Analytical and problem-solving skills
- Proven ability to work cross-functionally to achieve business outcomes
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