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
- Review and release products based on established QC metrics
- Monitor QC data
- Investigate product/process/quality issues
- Review of CAPAs, process deviations, root cause analysis
- Preparation of product and process quality reports by collecting, analyzing, and summarizing information and trends
- Write/review product quality documentation
- Follow regulatory and ISO 13485 requirements
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
