The Quality Control Specialist conducts GMP analytical testing, ensures data accuracy, maintains lab standards, and mentors junior analysts in a regulated environment.
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.
Synthego Menlo Park, California, USA Office
3565 Haven Ave, Suite 1, Menlo Park, CA, United States, 94025
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