QA Associate II - Batch Release & Compliance (On-Site)

Twist Bioscience Corporation; Wilsonville (OR); On-site; USD 75,000 - 115,000; Full time

Job summary

Twist Bioscience Corporation seeks a QA Associate II to ensure accurate, compliant batch release in an ISO 13485 manufacturing environment. You will review batch records, release raw materials and lots, support quality events, and mentor peers on release processes on-site in Wilsonville, OR.

You will collaborate with production, equipment and SMEs, support internal and external audits, and help maintain inspection readiness with strong cGMP/IVD knowledge and clear communication.

Qualifications

• Bachelor's degree in a scientific/engineering field.
• 2-3 years in the medical device/pharmaceutical/biotech industry.
• Minimum 2 years of QA or Regulatory Compliance (e.g. GCP, cGMP, GLP).
• Familiarity with regulatory requirements for IVD, ISO 13485, 21CFR820, MDD; experience in medical device/biotech manufacturing.

Responsibilities

• Release of products per batch records and SOPs.
• Materials management including Raw Material Release and nonconformance disposition.
• Investigate Quality events and support root cause analysis.
• Support internal and external audits and maintain inspection readiness.

Skills

Attention to detail

Communication skills

Analytical thinking

Cross-functional collaboration

Mentoring peers

Education

Bachelor's degree in scientific/engineering field

Tools

Confluence

JIRA

Job description

Twist Bioscience Corporation seeks a QA Associate II to ensure accurate, compliant batch release in an ISO 13485 manufacturing environment. You will review batch records, release raw materials and lots, support quality events, and mentor peers on release processes on-site in Wilsonville, OR.

You will collaborate with production, equipment and SMEs, support internal and external audits, and help maintain inspection readiness with strong cGMP/IVD knowledge and clear communication.