Quality Control Senior Specialist

2 months ago

Redwood City, California, United States Synthego Full time

The Quality Control Sr. Specialist will join our Quality team to be a key player in all scientific and documentation aspects of product development, release, stability, and investigations in support of maintaining and improving processes within the CRISPRevolution Production Team at Synthego.

What You'll Do:

  • Lead test method optimization, continuous improvement, development, and validation activities for new QC assays and test methods.
  • Drive QC troubleshooting and investigation efforts.
  • Perform automated and manual assays as detailed in established SOPs and QC test method procedures, including raw material, in-process and finished product.
  • Conduct QC testing with a variety of analytical techniques such as NGS and PCR, but also including LC/MS, HPLC, GC, UV/Vis, Endotoxin, and Raman spectroscopy as required.
  • Interpret test results against specifications to support material dispositioning.
  • Perform testing for product stability, environmental monitoring, endotoxins, and bioburden as required.
  • Maintain complete and accurate production records in conformance with GMP and FDA requirements.
  • Lead specification setting, design verification and validation, test method validation, failure mode effects analyses, design reviews and tech transfer activities.
  • Lead development and continuous improvements for test methods, equipment acquisition and onboarding, sample plans, and validation.
  • Support routine preventive maintenance, general troubleshooting, general cleanliness and calibration of laboratory equipment.
  • Support internal and external customer inquiries and requests as relevant to product quality and integrity.
  • Trend QC data results.
  • Update departmental SOPs and QC test procedures.
  • Order required laboratory supplies, reagents and other consumables.
  • Monitor proper storage conditions and expiration dates.
  • Dispose of hazardous and biohazardous materials.
  • Maintain samples in accordance with established procedures.
  • Prepare QC test samples required for QC functional testing.
  • Perform other duties as assigned.

About You:

  • Master's or Bachelor's degree in Biology, Chemistry, Molecular Biology, or equivalent technical field.
  • 5+ years in a regulated Quality Control or similar role with working knowledge of cGMP, ICH guidance, CFR 21 Part 11, and change control.
  • Industry experience on QC team(s) leading implementation of next-generation sequencing (NGS) testing for in-process and final product release of CRISPR sgRNA or similar product types
  • Be able to analyze, understand and effectively communicate technical material.
  • Be able to organize and prioritize tasks in a dynamic work environment.
  • Relevant combinations of education, experience, certifications, and merit may be considered upon management review.

Nice to Have:

  • Experience with mentoring and training other analysts in NGS on a QC team supporting 24/7 production activities.

Company Perks & Benefits:

  • Equity options
  • Medical, dental, and vision benefits
  • 401k Program
  • Fully stocked kitchen with beverages & snacks
  • 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.

The company leverages machine learning, automation, and gene editing to build platforms for science at scale. With its foundations in engineering disciplines, the company's platforms vertically integrate proprietary hardware, software, bioinformatics, chemistries, and molecular biology to advance basic research, target validation, and clinical trials.

By providing both commercial and academic researchers and therapeutic developers with unprecedented access to cutting-edge genome engineering, Synthego is at the forefront of innovation, accelerating the development of truly engineered biology.

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