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.
Collaboration & Interaction
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.