Quality Control Specialist

Posted 5 Days Ago
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Redwood City, CA, USA
In-Office
Mid level
Biotech
The Role
The Quality Control Specialist conducts GMP analytical testing, ensures data accuracy, maintains lab standards, and mentors junior analysts in a regulated environment.
Summary Generated by Built In
The QC Specialist performs GMP analytical testing with increased independence, contributes to first-pass data review, and supports QC documentation and operational reliability.
 
This role builds on foundational analytical skills and requires consistent execution across multiple method platforms. 

Available Shift:

    Shift: Day
    Hours: 8:00am to 4:30pm 
    Days: Tuesday to Saturday 

What You'll Do:

  • Execute routine QC assays per approved SOPs (HPLC, LC/MS, UV/Vis, qPCR, endotoxin, NGS, etc.) with minimal supervision. 
  • Prepare and manage samples, reagents, standards, and controls following ALCOA+ principles. 
  • Maintain instrument cleanliness and perform basic assay troubleshooting; escalate instrument or complex issues. 
  • Document all work accurately, contemporaneously, and in compliance with GMP and GDP expectations. 
  • Conduct first-pass data checks for accuracy, completeness, and compliance. 
  • Assist in drafting deviations, nonconformances, or technical summaries with guidance. 
  • Contribute to SOP, worksheet, and test method updates under SME direction. 
  • Support method qualification, execution of method transfer activities, or controlled studies. 
  • Maintain lab organization, equipment readiness, and material inventory. 
  • Mentor junior analysts on routine methods and laboratory best practices. 
  • Perform other duties as assigned. 

About You:

  • Bachelor’s degree in Biology, Chemistry, Molecular Biology, or related scientific field. 
  • 3+ years experience in QC or a regulated analytical laboratory. 
  • Ability to follow detailed SOPs and work with precision and consistency. 
  • Strong attention to detail and adherence to data integrity principles. 
  • Demonstrated proficiency in at least two analytical platforms (HPLC, LC/MS, NGS, etc.). 
  • Working knowledge of GMP, GDP, and general data integrity expectations. 
  • Relevant combinations of education, experience, certifications, and merit may be considered upon management review. 

Perks & Benefits

  • Medical, dental, and vision benefits
  • 401k Program
  • Catered meals on Tuesday and Thursday
  • Paid parental leave
  • Flexible paid time off
  • Education Reimbursement Program

Our Mission
Synthego® is a pioneering force in the biotechnology industry, dedicated to advancing the frontiers of CRISPR cell and gene therapies through cutting-edge CRISPR technology and expertise. Our mission is to provide unparalleled access to CRISPR solutions at scale, empowering applications from Discovery to Clinic. Driven by a visionary approach, we strive to accelerate the therapeutic development process with best-in-class CRISPR solutions, simplified licensing & expert guidance, driving the adoption and success of CRISPR-based therapies to benefit all patients.

Skills Required

  • Bachelor's degree in Biology, Chemistry, Molecular Biology, or related scientific field
  • 3+ years experience in QC or a regulated analytical laboratory
  • Demonstrated proficiency in at least two analytical platforms
  • Working knowledge of GMP, GDP, and general data integrity expectations
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The Company
HQ: Menlo Park, CA
443 Employees
Year Founded: 2012

What We Do

Synthego is a genome engineering company enabling the acceleration of life science research and development in the pursuit of improved human health. The company leverages machine learning, automation, and gene editing to build platforms for science at scale. By vertically integrating hardware, software, bioinformatics, chemistry, and molecular biology, Synthego is at the forefront of innovation advancing the next generation of medicines through providing access to genome editing at an unprecedented scale. //// Our Culture of Diversity: Different Faces from Different Places At Synthego, our differences make us unique, help us innovate, and allow us to persevere. We stand firmly behind our values, strive to achieve representation, and celebrate diversity in perspectives and backgrounds. We welcome all team members to be their best selves as we move forward towards fulfilling our shared vision of revolutionizing genome engineering technology to help make biological therapies accessible to all patients.

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