QA Associate II

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

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), nonconformance disposition and release activity as applicable.
• Collaborates with SMEs to investigate Quality event tickets and assign, approve, or follow up on approval and disposition of these events.
• Review and releases IQOQPQs through collaboration with the Equipment team.
• Support the tracking and trending relevant quality metrics as assigned.
• Support investigations, root cause analysis, and documentation of findings on Quality Events.
• Conduct lab walkthroughs on a periodic basis and report and follow up on findings.
• Effectively influences (by serving as a peer mentor) and trains employees on basic releases and processes.
• Supports internal and external audits via gathering and preparation of audit material.
• Support additional responsibilities as assigned.
• Ability to be on‑site to inspect products/materials and release lots.
• Follow regulatory and ISO 13485 requirements.

Complexity & Problem Solving

Executes tasks/assignments that have clear and established processes and procedures. At times, tasks/assignments require occasional adaptation beyond established processes and procedures.

Follows established procedures on routine work, receives instructions only on new assignments.

Typical Degree & Years of Experience

• 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.
• Experience working and/or supporting production/laboratories a plus.
• Familiarity with regulatory requirements for IVD Products, ISO 13485, 21CFR820, MDD, applicable experience in medical device, or biotech manufacturing and a thorough knowledge and understanding of cGMP.
• Familiarity with Confluence and JIRA applications desired.
• Strong written and verbal communication skills.
• Analytical and problem‑solving skills.
• Proven ability to work cross‑functionally to achieve business outcomes.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Twist Bioscience’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service‑connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.