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Sr. Quality Control Specialist

Synthego

Synthego

This job is no longer accepting applications

See open jobs at Synthego.
Quality Assurance
Redwood City, CA, USA
Posted on Tuesday, December 5, 2023
The Quality Control Specialist will join Synthego’s Quality Control laboratory as a key player to support method validation activities, stability program, change controls, CAPAs, and investigations for QC.
Shifts Available: Monday – Friday, 8am - 5pm

What You'll Do

  • Lead method qualification/validation for biological and chemical quality control (QC) assays by authoring protocols and reports and executions
  • Responsible for quality events and records in Quality Control, e.g. initiating change controls, investigating out-of-specification/out-of-trend results, and CAPAs
  • Collaborate with Contract Test Laboratories and other outside entities;
  • Coordinate receipt, tracking, storage, shipment and distribution of Stability, Raw Material and In-process QC samples.
  • Assist with audits and audit responses
  • Support and lead creation/revision of QC SOPs, Stability protocols and reports, and specifications.
  • Conduct QC testing with a variety of analytical techniques such as LC/MS, HPLC, GC, UV/Vis, Endotoxin, Raman spectroscopy, PCR, and NGS.
  • Review and approve test method results for conformity to specification

About You

  • 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
  • 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.
  • Experience working on a QC team supporting 24/7 production activities.
  • Industry experience on QC team(s) supporting implementation of next-generation sequencing (NGS) testing for in-process and final product release.

Preferred Qualifications

  • Experience working on a QC team supporting 24/7 production activities.
  • Industry experience on QC team(s) supporting implementation of next-generation sequencing (NGS) testing for in-process and final product release.

Company Perks & Benefits

  • Generous equity
  • Medical, dental, and vision benefits
  • 401k program
  • Subsidized catered lunches and dinners with stocked kitchens & snacks
  • 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.

This job is no longer accepting applications

See open jobs at Synthego.