QA Associate II: On-Site Release & Compliance Expert

Twist Bioscience Corporation; Portland (OR); On-site; USD 70,000 - 95,000; Full time

Job summary

Twist Bioscience Corporation is seeking a QA Associate II to lead batch record reviews, raw material and lot release, and support quality events in an ISO 13485 environment.

The role partners with production and SMEs to investigate quality events, perform root cause analyses, and maintain inspection-ready documentation and processes. On-site work and mentoring peers are key aspects of this position.

Qualifications

• Bachelors in science/engineering required; knowledge of quality systems.
• 2–3 years in QA or Regulatory Compliance in biotech/medical device.
• Familiarity with ISO 13485, cGMP, and IVD regulations.
• Experience supporting audits and documentation control.

Responsibilities

• Review and release manufacturing batch records and materials per SOPs.
• Investigate quality events, assist root cause analysis and CAPA.
• Support internal and external audits with prepared materials.
• Mentor peers on release processes and compliance.
• Ensure on-site release of products/materials and regulatory adherence.

Skills

Attention to detail

Cross-functional collaboration

Documentation skills

GxP knowledge

Education

Bachelor's degree in a scientific/engineering field

Tools

Confluence

JIRA

Job description

Twist Bioscience Corporation is seeking a QA Associate II to lead batch record reviews, raw material and lot release, and support quality events in an ISO 13485 environment.

The role partners with production and SMEs to investigate quality events, perform root cause analyses, and maintain inspection-ready documentation and processes. On-site work and mentoring peers are key aspects of this position.