QC Associate II

Twist Bioscience • Portland, OR

2d

About The Position

The QC Associate II will be responsible for the implementation and continuous improvement of QC methods in the production laboratory. He/she will work closely with the operations team to monitor the quality of Twist DNA products utilizing quantitative measurements, fragment analysis, NGS sequencing, etc. The successful candidate must have a demonstrated capability of making data driven decisions in a high throughput environment to assure that all products processed, packaged, stored, and distributed are manufactured in compliance with all Regulatory, Customer, and Twist requirements.

Requirements

• BS/MS in Biochemistry, Chemistry, Molecular Biology or related field
• 2+ years industrial experience in Operations/QC

Nice To Haves

• Knowledge of/experience with Quality Control and Quality Assurance principles, including GMP/ISO
• Knowledge of molecular biology techniques such as PCR, Cloning & Sequencing
• Knowledge of analytical techniques such as spectroscopy, gel electrophoresis, etc.
• Experience with automated robotic systems and LIMS systems
• Proven ability to troubleshoot complex problems
• Excellent verbal and written communication skills

Responsibilities

• Independently perform QC release for standard product families to ensure 100% compliance with customer specifications.
• Execute and troubleshoot routine QC assays (NGS, qPCR, fragment analysis, NanoDrop/Qubit); identify and escalate atypical results.
• Initiate Nonconformances and other Quality Events for OOS, OOT, and atypical results, and follow up on progress and action items.
• Support impact assessments and investigations; contribute to root cause analysis using 5-Why, Fishbone, and DMAIC techniques.
• Review CAPAs and process deviations from a QC perspective.
• Monitor QC data and assist in preparation of product and process quality reports, including trend analysis.
• Author and review product quality documentation (SOPs, test methods, work instructions, labels).
• Maintain QC batch records, calibration records, and inventory under ISO and GDP requirements.
• Identify and support continuous improvement initiatives in the QC laboratory.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level