synthego

Quality Control Lead: Synthego

Date Posted / Modified: February 16, 2017

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Redwood City, California, United States – We are looking for a Quality Control Lead who will ensure the quality of processes and products in support of all manufacturing areas within Synthego.

This position will own numerous projects, help build the tools to enable industrial-scale molecular biology research, and bring automation to genome engineering.

Responsibilities

  • Analyze manufacturing data and information for quality, consistency, and accuracy
  • Develop quality control measurements with the R&D team to properly qualify and release production batches
  • Use a variety of analytical and sample handling equipment (i.e. HPLC, Mass Spec) to determine pass/fail status of oligos
  • Fully understand the manufacturing processes
  • Maintain accurate and detailed sample, product and instrument records
  • Perform necessary emergency, safety and cleaning procedures
  • Handle sample and reagent preparations (carefully and accurately)
  • Perform internal audits to ensure manufacturing personnel are performing tasks accurately and effectively per Synthego’s SOP’s
  • Create corrective and preventive actions in order to eliminate and prevent the causes of nonconformance
  • Initiate process improvement and validate actions taken and measures their differences
  • Ensure SOPs are current, complete and reflects the laboratory practice
  • Review proficiency testing samples required to maintain laboratory certification and reviewing blind performance sample results
  • Identify projects geared towards improving quality, reducing manufacturing costs and improving product turnaround
  • Assist Team Leads with establishing and/or reviewing work instructions and resulting training of employees
  • Successfully completes any required training and ensures Quality Standards are maintained within manufacturing

Requirements

  • 5-10 years working in a Quality Control Group
  • Aseptic material handling including BSL2 environments
  • Broad knowledge of Quality System implementation and maintenance including but not limited to batch records review and lot release, non-conformance management, effective CAPA programs, changes control programs
  • Strong analysis and problem solving skills
  • Ability to work in a dynamic, fast paced environment with shifting priorities
  • Responsible and committed to a customer service mentality to ensure high quality data is provided to internal and external customers
  • Adaptability to performing under stress when confronted with critical, unusual, or dangerous situations including situations in which working pace and sustained attention are make-or-break aspects of the job
  • Experience working under cGMP or ISO13485 systems

Company Perks & Benefits 

  • Competitive salary
  • Generous equity at an early stage company
  • Tax-exempt medical insurance reimbursement
  • Fully stocked kitchen and snacks
  • Free catered lunches and dinners
  • Onsite Machine Shop

 

ABOUT SYNTHEGO

Synthego is turning molecular biology into an information science. We’re building hardware facilities that abstract biological syntheses and research into software.

Our vision is to bring automation to genome engineering, enabling scientists to run their own fully-automated laboratory at low cost, performing millions of controlled, repeatable experiments per day without human error.

Founded by former SpaceX engineers, Synthego is a leading provider of genome engineering solutions.  The company’s flagship product, CRISPRevolution, is a portfolio of synthetic RNA designed for CRISPR genome editing and research.

We are venture backed by Founders Fund, Menlo Ventures, 8VC, and WI Harper.

 

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