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Quality Engineer at Synthego
Redwood City, CA, US
Synthego is searching for a Quality Engineer to join our team and help create the world’s first fully automated cloud-enabled lab.
 
The perfect candidate would thrive in a fast-paced, dynamic environment. You will have a player-coach mentality with the ability to adapt to changing requirements and priorities. Possessing the ability to partner with cross-functional leaders to exact change and drive continuous Quality improvement is a must.

What You'll Do

    • Maintains GMP Validation Master Plan list of equipment and ensures qualification timelines are performed on-time
    • Performs IQ/OQ/PQ of GMP equipment/instrumentation and requalifications
    • Performs annual Cleaning Validations for GMP Manufacturing Processes
    • Performs annual GMP Cleanroom Performance Qualification (PQ) Maintains GMP pFMEA and Risk Assessments and annual reviews
    • Perform root cause investigations related to Non-conformance, Deviations and Customer Complaints.
    • Collaborate with cross-functional teams to implement robust Corrective and Preventive Actions (CAPA).     
    • Review and approve change controls as appropriate.
    • Review and approve project life-cycle documentation including commissioning and validation packages.
    • Represents Quality in site equipment, facility, utility and laboratory systems projects.
    • Identifies compliance gaps, recommends process improvements, and proposes changes.
    • Supports internal and regulatory audits/inspections as required.
    • Participates in continuous improvement activities and projects.
    • Participates in authoring or revising Standard Operating Procedures (SOPs) to ensure compliance and quality objectives are met.
    • Assist with implementation and management of various quality systems including, but not limited to, Deviation Management, Non conformance Management, CAPA Management, Validation Master Plan, Risk Management and Change Control in a GMP and RUO manufacturing environment. 
    • Present and defend Quality records and data packages during external customer or Regulatory inspections. 

About You

    • 3+ years of relevant experience in a life science company with increasing levels of responsibility.
    • Minimum of Bachelor’s Degree in an Engineering discipline or equivalent experience.
    • Possess working knowledge of cGMP, ICH Q7, ICH Q10 and/or ISO 9001 systems.
    • Possess working knowledge of ISO 14971 Risk Management Possess working knowledge of Quality Management Systems (QMS), processes, and procedures.
    • Experience in Biotech or a Biopharmaceutical environment is highly desired.Strong user of excel or statistical programs.
    • Familiarity with problem-solving, root cause analysis tools, impact assessment, and CAPAs.
    • Experience with Quality Management Systems 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 benefits401k Plan
    • Fully stocked kitchen and snacks
    • Catered lunches and dinners
    • 4x daily Shuttle bus to & from San Francisco
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.