We are seeking candidates interested in working for an exciting start-up company located in San Francisco. This role is based in South San Francisco with frequent travel to our San Francisco site. This is an ideal opportunity for individuals who thrive in a changing environment and enjoy supporting and delivering world-class products that meet both external and internal customer needs.
This is a role for someone who craves a challenge balanced by the desire to be accountable for delivering high quality products for Twist. It is both a strategic and a tactical position. Those that do not want to get their hands dirty should not apply.
The Quality Assurance Specialist will be responsible for developing and enforcing the QMS system at Twist. The prime objective is to work cross-functionally to implement and enforce good manufacturing practices in a start-up environment. The roadmap to quality leads to the ultimate goal of achieving ISO 9001:2015 and 13485:2016 certifications. The successful candidate must have demonstrated the ability to interpret and implement quality assurance standards in the life sciences industry. This includes experience in supplier quality, audits, discrepancy reports, change control, and CAPA procedures.
Job Duties include but are not limited to:
- Perform SOPs periodic review, write/revise SOPS and design process flowcharts
- Draft quality assurance policies and procedures
- Interpret and implement quality assurance standards
- Evaluate adequacy of quality assurance standards
- Devise sampling procedures and directions for recording and reporting quality data
- Review the implementation and efficiency of quality and inspection systems
- Plan, conduct and monitor testing and inspection of materials and products to ensure finished product quality
- Document internal audits and other quality assurance activities
- Investigate customer complaints and non-conformance issues
- Collect and compile statistical quality data
- Analyze data to identify areas for improvement in the quality system
- Develop, recommend and monitor corrective and preventive actions
- Prepare reports to communicate outcomes of quality activities
- Identify training needs and organize training interventions to meet quality standards
- Coordinate and support on-site audits conducted by external providers
- Evaluate audit findings and implement appropriate corrective actions
- Monitor risk management activities
- Assure ongoing compliance with quality and industry regulatory requirements
- MS in Biochemistry, Chemistry, Molecular Biology or related field
- 5+ years industrial experience in GxP Quality Systems
- In-depth knowledge of ISO 9001:2015 & 13485:2016
- In-depth knowledge and experience with Operational Excellence Principles
- Knowledge of relevant regulatory requirements
- Product or industry-specific experience
- Experience with quality inspections and audits
- Experience with implementation of corrective action programs
- Strong computer skills including Microsoft Office and databases
- Certifications an advantage including Quality Auditor, Quality Engineer, Quality Improvement Associate, Six Sigma a major plus
- Technical writing skills
About Twist Bioscience
At Twist Bioscience, our expertise is synthetic DNA. We have developed a proprietary semiconductor-based synthetic DNA manufacturing process featuring a 10,000-well silicon platform capable of producing synthetic biology tools, such as oligonucleotides, genes, pathways, chassis and genomes. By synthesizing DNA on silicon instead of on traditional 96-well plastic plates, our platform overcomes the current inefficiencies of synthetic DNA production, and enables cost-effective, rapid, high-quality and high throughput synthetic gene production. The Twist Bioscience platform has the potential to greatly accelerate the development of personalized medicine, sustainable chemical production, improved agriculture production as well as new applications such as in vivo diagnostics, biodetection and data storage. For more information, please visit www.twistbioscience.com. Twist Bioscience is on Twitter. Sign up to follow our Twitter feed @TwistBioscience at https://twitter.com/TwistBioscience.
Twist Bioscience is an equal opportunity employer.
MUST BE ABLE TO TRAVEL TO BOTH SF AND SSF