New · posted Oct 15
Twist Bioscience · Biotechnology
QA Associate II
- Portland, OR
- On-site
- Full-time
- Associate & Specialist
Open until filled
The role
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.
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.
Collaboration & Interaction
Follows established procedures on routine work, receives instructions only on new assignments.
What you need
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.
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.
Where you'll work
Portland, OROn-siteOpen in Maps (opens in a new tab)
More jobs in Portland, ORJob intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
Associate & Specialist roles in the US157 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $59,000 | $78,500 | $94,000 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Twist Bioscience's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 27 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs9
- Collaboration and leadership6
- GMP and compliance5
- Investigations and CAPA4
- Quality systems and risk4
- Lab testing and methods2
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Twist Bioscience on Regulatory Jobs
- 3
- Open roles
- 3
- Distinct roles
- 2
- Locations
By discipline
- Quality2 67%
- Regulatory1 33%
By level
- Associate & Specialist2 67%
- Manager1 33%
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QA Associate II at Twist Bioscience
Open until filled.