Perform QC testing and product release for Twist DNA products using quantitative assays, fragment analysis, and NGS. Monitor QC data, lead investigations and root cause analysis, review CAPAs and deviations, draft SOPs and quality reports, and ensure regulatory and ISO 13485 compliance in a high-throughput production laboratory.
The QC Associate II is responsible for the implementation and continuous improvement of Quality Control methods within the production laboratory. Working closely with the Operations team, you will monitor the quality of Twist DNA products using quantitative measurements, fragment analysis, and Next-Generation Sequencing (NGS).
The successful candidate will demonstrate a proven ability to make data-driven decisions in a high-throughput environment. Your primary mission is to ensure that all products—from processing and packaging to storage and distribution—comply with Regulatory, Customer, and Twist internal standards.
Onsite position: Wed-Saturday 7:00 AM - 5:30 PM - South San Francisco
What You’ll Be Doing- Product Release: Review and release products based on established QC metrics and rigorous quality standards.
- Data Monitoring: Continuously monitor QC data to identify trends and ensure process stability.
- Issue Resolution: Lead investigations into product, process, and quality issues to identify and mitigate risks.
- Quality Compliance: Review CAPAs and process deviations; perform thorough root cause analysis (RCA) to prevent recurrence.
- Reporting: Prepare comprehensive product and process quality reports by collecting, analyzing, and summarizing key information and performance trends.
- Documentation: Draft and review critical product quality documentation and Standard Operating Procedures (SOPs).
- Regulatory Adherence: Ensure all laboratory activities follow strict regulatory guidelines and ISO 13485 requirements.
- Education: BS or MS in Biochemistry, Chemistry, Molecular Biology, or a related scientific field.
- Experience: 2+ years of professional experience in an industrial Operations or QC setting.
- Communication: Excellent verbal and written communication skills with the ability to collaborate across departments.
- Quality Standards: Strong working knowledge of QC/QA principles, including GMP and ISO 13485 environments.
- Molecular Biology: Proficiency in techniques such as PCR, Cloning, and NGS.
- Analytical Expertise: Hands-on experience with spectroscopy, gel electrophoresis, and fragment analysis.
- Systems & Automation: Familiarity with automated robotic platforms and Laboratory Information Management Systems (LIMS).
- Problem Solving: A proven track record of troubleshooting and resolving complex technical problems.
The base cash compensation for this California-based role is below. In addition to base salary, this role is eligible for bonus, equity, and a generous benefits package. Final compensation amounts are determined by multiple factors, including candidate skill, experience, expertise, and location and may vary from the amount listed above. Compensation may be different in other locations.
San Francisco Bay Area Pay Range
$25—$36 USD
Twist Bioscience San Francisco, California, USA Office
455 Mission Bay Blvd South, 6th Floor, San Francisco, CA, United States, 94158
Twist Bioscience South San Francisco, California, USA Office
681 Gateway Blvd, South San Francisco, CA, United States, 94080
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