Full-Time
Quality Assurance Specialist
Confirmed live in the last 24 hours
Synthego
201-500 employees
Provides synthetic RNA and gene editing tools
Compensation Overview
$105k - $115kAnnually
Junior, Mid
San Carlos, CA, USA
Position requires onsite presence in Redwood City, CA.
- Bachelor’s degree in Science (Chemistry, Biochemistry, Microbiology) or Engineering
- 2+ years in Quality Assurance; or experience working in a cGMP regulated environment with positions of progressive responsibility.
- Experience executing process improvement or overseeing CAPA processes in a cGMP environment
- Expertise in Standard Operating Procedures, Good Manufacturing Practices: ISO 9001
- Overall understanding of Quality Assurance specifications and process
- Ability to communicate and work cross functionally with other teams.
- Ability to influence in a team environment and collaborate with peers.
- Performance focused, persistent, sound decision-making, open minded, innovative/creative and results oriented.
- Ability to work effectively on problems of diverse scope, with analysis/evaluation of data.
- High level of personal motivation and initiative, and ability to work independently on projects. Attention to detail, safety, quality and customer requirements.
- Proficiency with MS Office and GSuite products.
- Continues to build on professional concepts toward culture of quality in compliance with ISO 9001:2015 standards and FDA regulations
- Trend Quality indicators and lead continuous improvement of QMS.
- Establish and oversee key quality system programs including, Corrective and Preventive Actions, Deviations, Non-Conformances and Customer Complaints for all different product lines.
- Proactively investigates root cause of deviations (planned and unplanned); may work independently or cross-functionally across the organization to troubleshoot and provide resolution.
- Conducts risk assessments of failures and makes recommendations for problem resolution and prevention, in accordance with compliance requirements
- Participates in product development or improvement initiatives, ensuring internal and regulatory compliance
- Responsible for reviewing and managing applicable Standard Operating Procedures (SOPs) and Work Instructions (WI) related to continuous improvement.
Synthego specializes in biotechnology, focusing on genetic engineering by providing synthetic RNA and gene editing tools. Their products enable scientists to modify genes, which can lead to advancements in disease treatment and agricultural improvements. Synthego serves a variety of clients, including research institutions, pharmaceutical companies, and biotech startups, who utilize their products for drug discovery, disease modeling, and genetic research. The company stands out in the growing genetic engineering market by offering a platform that grants users access to advanced gene editing capabilities, alongside their synthetic RNA products. Synthego's goal is to support and enhance genetic research and applications through their tools and services.
Company Stage
Series E
Total Funding
$459.7M
Headquarters
Menlo Park, California
Founded
2012
6 month growth
↓ -11%1 year growth
↓ -38%2 year growth
↓ -57%
Simplify's Take
What believers are saying
- Synthego's licensing agreement with HuidaGene for the hfCas12Max nuclease positions it at the forefront of CRISPR-based therapeutic applications.
- The addition of Dr. Bill Skarnes to the advisory board and the launch of high-throughput induced pluripotent stem cell genome engineering highlight Synthego's commitment to innovation and expertise.
- The opening of a new GMP synthesis facility and the launch of IND-enabling gRNAs bolster Synthego's support for the entire discovery-to-clinic continuum, enhancing its market position.
What critics are saying
- The rapid pace of innovation in the genetic engineering field requires Synthego to continuously advance its technologies to stay competitive.
- Leadership changes, such as the recent CEO transition, could lead to strategic shifts and potential instability within the company.
What makes Synthego unique
- Synthego's focus on synthetic RNA and advanced gene editing tools, such as the high-fidelity Cas12 CRISPR nuclease, sets it apart from competitors who may not offer such specialized products.
- The company's strategic partnerships, like those with HuidaGene and bit.bio, enhance its capabilities in developing next-generation CRISPR-based therapies and synthetic circuitry in cells.
- Synthego's state-of-the-art GMP manufacturing facility ensures high-quality production of CRISPR components, providing a competitive edge in the clinical development of gene editing therapies.
Help us improve and share your feedback! Did you find this helpful?
Benefits
Generous Equity Package
Medical, Dental & Vision
401(k) Plan
Catered to You
Fully Stocked
Transportation
Green Environment
Stay Fit
Legal Ease