QA Associate II

Twist Bioscience•Portland, OR

16h•Onsite

About The Position

The QA Associate II ensures 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. The role works in an ISO 13485 manufacturing environment and partners with production, equipment teams, and subject matter experts to investigate quality events, support root cause analysis, and maintain inspection-ready documentation and processes. Success requires a strong working knowledge of cGMP and IVD regulatory requirements, attention to detail, and clear communication. This is a hands-on, on-site role that also includes mentoring peers and supporting internal and external audits. The position performs work with clear, established processes and procedures, with occasional need to adapt beyond them. Routine work follows established procedures, while new assignments receive instructions.

Requirements

Bachelor’s degree or equivalent in a scientific or engineering-related field.
2–3 years of experience in the medical device, pharmaceutical, or biotechnology industry.
At least 2 years of Quality Assurance or Regulatory Compliance experience, such as GCP, cGMP, or GLP.
Familiarity with regulatory requirements for IVD products, ISO 13485, 21 CFR 820, or MDD, and applicable experience in medical device or biotechnology manufacturing.
Thorough knowledge and understanding of cGMP.
Strong written and verbal communication skills.
Analytical and problem-solving skills.
Proven ability to work cross-functionally to achieve business outcomes.
Ability to work on-site to inspect products and materials and release lots.

Nice To Haves

Experience working in or supporting production or laboratories.
Familiarity with Confluence and JIRA applications.

Responsibilities

Ensure accurate and safe release of synthetic biology products in accordance with company and client procedures and requirements.
Promote compliance with applicable ISO, cGMP, IVD regulations, and company and client SOPs.
Author and review SOPs, batch records, labels, and other documents.
Review, control, and release manufacturing batch records, including label verification.
Manage materials, including raw material release, nonconformance disposition, and release activity as applicable.
Collaborate with subject matter experts to investigate quality event tickets and assign, approve, or follow up on event approval and disposition.
Review and release IQOQPQs in collaboration with the Equipment team.
Support tracking and trending of assigned quality metrics.
Support investigations and root cause analysis, and document findings on quality events.
Conduct periodic lab walkthroughs, report findings, and follow up on them.
Mentor peers and train employees on basic releases and processes.
Support internal and external audits by gathering and preparing audit materials.
Work on-site to inspect products and materials and release lots.
Follow regulatory and ISO 13485 requirements.
Perform additional responsibilities as assigned.