This position is responsible for oversight of all Deviations, Non-conformances, Customer Complaints and Corrective/Preventive Actions at Synthego. The ideal candidate will be responsible for improving the current processes and bringing in new systems for process improvement as a part of the Quality Assurance team.
What You'll Do:
- 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
About You:
- 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.
Company Perks & Benefits:
- Equity options
- Medical, dental, and vision benefits
- 401k Program
- Catered meals on Tuesday and Thursday
- Paid parental leave
- Flexible paid time off
About Us
Synthego is a genome engineering company that enables the acceleration of life science research and development in the pursuit of improved human health.
Based on a foundation of engineering and chemistry, Synthego leverages automation and machine learning to synthesize high-quality CRISPR reagents for science at scale. Synthego’s mission is to enable agile life science research and development from discovery through clinical trials by providing scientists with comprehensive CRISPR solutions for each phase coupled with full technical and regulatory support from industry-leading experts.
With its technologies cited in hundreds of peer-reviewed publications and utilized by thousands of commercial and academic researchers and therapeutic drug developers, Synthego is at the forefront of innovation, enabling the next generation of medicines by delivering genome editing at an unprecedented scale.
