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Quality Control Analyst

Synthego

Synthego

IT, Quality Assurance
Redwood City, CA, USA
Posted on Dec 31, 2024
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The Quality Control Analyst 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.
*Available shift: Monday-Friday (Swing - 2:30pm-11:00pm PST)

What You'll Do:

  • Conduct Routine testing of raw materials, In-process, stability and finished goods samples from the manufacturing process step
  • Conduct testing following SOPs using LCMS, HPLC, UV/Vis, Wet Bench chemistry,Raman spectroscopy, pH as well as Microbiology and Environmental testing such as Endotoxin , Bioburden, and others.
  • Conduct molecular biology testings following SOPs to perform PCR, DNA sequencing and cloning. Experience with Illumina sequencer is highly desirable.
  • Conduct routine QC lab cleaning and maintenance.
  • Conduct QC equipment preventive maintenance or calibration.
  • Conduct shipping inspection of Finished Goods.
  • Conduct QC reagent inventory and order reagents and supplies.
  • Assist in QC reagent qualification and studies.
  • Trend EM and QC data results
  • Document, analyze, and interpret QC and experimental data.
  • Responds to internal and external customer inquiries and requests as relevant to product quality or integrity.
  • Investigates customer complaints and obtains data for customer inquiries that are relevant to QC.
  • Management of contract testing labs for in-process and final release assays.
  • Provides troubleshooting support for analytical equipment (LC-MS, HPLC, GC)

About You:

  • Ability to identify customer needs and issues and develop realistic solutions to meet needs and solve problems.
  • Ability to communicate recommendations and decisions across the organization.
  • 1+ years in a regulated Quality Control or similar role
  • Bachelor’s Degree in a Chemistry or Biochemistry or scientific discipline and/ or equivalent experience.
  • Possess working knowledge of cGMP
  • Strong communication skills
  • High degree of attention to detail
  • Analytical instrumentation experience, including instrument troubleshooting, is preferred (e.g. ESI-MS, LC-MS, HPLC, GC, bioburden testing, endotoxin testing, KF, UV/VIS etc.)

Company Perks & Benefits

  • Equity options
  • Medical, dental, and vision benefits
  • 401k Program
  • Catered meals on Tuesday and Thursday
  • Paid parental leave
  • Flexible paid time off
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.
Apply now
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