Startup Careers

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Quality Control Manager at Synthego
Redwood City, CA, US
We are seeking an exceptional individual to join us as the Quality Control Manager and implement quality control processes for our CRISPRevolution and Engineered Cells product lines. This position reports to the Director of Quality and has direct responsibility for the Quality Control functions of the organization.

What You'll Do

    • Lead the development and implementation of Product and Raw Material testing and controls.
    • Be the final decision maker for Lot release for made to order and made to stock products
    • Ensure Product Documentation is in accordance to our quality standards
    • Lead Continuous Improvement efforts for product testing and release
    • Establish Quality Metrics and report to executive team
    • Hire and lead a team of quality control specialists. 
    • Lead for Market Specification, Functional Specification, Design Verification, Design Validation, Test Method Validation, Failure Mode Effects Analyses, and Design Reviews.
    • Provide guidance to test methods, equipment acquisition, sample plan definition, and validation development.
    • Provide guidance and decisions on product development activities to ensure compliance with internal procedures and applicable regulatory or international standards. 
    • Document, analyze, and interpret QC and experimental data.
    • Responds to internal and external customer inquiries and requests as relevant to product quality or integrity.
    • Investigates customer complaints and obtains data for customer inquiries that are relevant to QC.
    • Manages development or transfer of new QC processes or improvements to existing QC processes through implementation with minimal assistance, including implementation of new QC equipment, methods, procedures, and/or software.
    • May engage in benchwork to develop methods. Develops equipment and process validation plans related to QC.
    • Recommends testing for manufacturing-related non-conformances and CAPAs.
    • Management of contract testing labs for in-process and final release assays.

About You

    • 5+ years relevant experience in a life science company with increasing levels of responsibility
    • Managed a team of scientists
    • Minimum of Bachelor’s Degree in a scientific discipline or equivalent experience
    • Possess working knowledge of cGMP and/or ISO13485 systems
    • Possess working knowledge of quality management systems (QMS), processes, and procedures
    • Familiarity with problem solving, root cause analysis tools, impact assessment, and CAPAs
    • Experience with QMS software platforms. Experience with Arena Solutions PLM is a plus
    • High degree of attention to detail
    • Strong documentation skills
    • Responsible and accountable with non-compromising high ethical standards

Company Benefits & Perks

    • Competitive salary
    • Generous equity at an early stage company
    • Robust medical, dental and vision benefits
    • 401k Plan
    • 4x daily Shuttle bus to & from San Francisco (more locations to come)
    • Fully stocked kitchen and snacks
    • Free catered lunches and dinners
ABOUT SYNTHEGO
 
Synthego’s vision is to turn biology into an information science, with the ultimate goal of dramatically extending the healthy human lifespan.
 
Synthego builds advanced bioinformatics and automated hardware platforms to create next-generation molecular biology tools, starting with full-stack genome engineering.
 
These world-class tools accelerate basic scientific discovery, critical disease cures and novel synthetic biology applications to improve and prolong life.