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. In this position you will report to the QC manager.
What You’ll Be Doing
- 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 You’ll Bring to the Team
- BS/MS in Biochemistry, Chemistry, Molecular Biology or related field
- 2+ years industrial experience in Operations/QC
Preferred Qualifications
- 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
Skills Required
- BS/MS in Biochemistry, Chemistry, Molecular Biology or related field
- 2+ years industrial experience in Operations/QC
- Experience executing and troubleshooting QC assays (NGS, qPCR, fragment analysis, NanoDrop/Qubit)
- Knowledge of/experience with Quality Control and Quality Assurance principles, including GMP/ISO
- Knowledge of molecular biology techniques such as PCR, cloning and sequencing
- Knowledge of analytical techniques such as spectroscopy and gel electrophoresis
- Experience with automated robotic systems and LIMS systems
- Proven ability to troubleshoot complex problems and strong verbal/written communication skills
What We Do
Twist Bioscience is a synthetic biology company based in South San Francisco, California. The company has developed a proprietary silicon-based manufacturing process for the production of synthetic DNA. Twist Bioscience serves Life Science researchers who are changing the world for the better. Coming from diverse fields of medicine, agriculture, industrial chemicals and data storage, scientists use our synthetic genes, oligo pools, and NGS target enrichment to better lives and improve the sustainability of the planet. Twist Bioscience is uniquely positioned to help accelerate these efforts by providing precision at a scale that is otherwise unavailable. Our technology overcomes inefficiencies and enables cost-effective, rapid, precise, high-throughput DNA synthesis and sequencing. We offer both the quality and quantity researchers need now to rapidly realize opportunities ahead.
