Quality Control Analyst

Posted 10 Days Ago
Be an Early Applicant
Redwood City, CA
30-34
Junior
Biotech
The Role
The Quality Control Analyst will conduct routine testing and investigations on product development and release processes, manage QC data and documentation, perform equipment maintenance, and respond to customer inquiries related to product quality.
Summary Generated by Built In

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

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.


Based on a foundation of engineering and chemistry, Synthego leverages automation and machine learning to synthesize high-quality CRISPR reagents for science at scale. Synthego’s mission is to enable agile life science research and development from discovery through clinical trials by providing scientists with comprehensive CRISPR solutions for each phase coupled with full technical and regulatory support from industry-leading experts.


With its technologies cited in hundreds of peer-reviewed publications and utilized by thousands of commercial and academic researchers and therapeutic drug developers, Synthego is at the forefront of innovation, enabling the next generation of medicines by delivering genome editing at an unprecedented scale.

Top Skills

Hplc
Lcms
Pcr
Uv/Vis
The Company
HQ: Menlo Park, CA
443 Employees
On-site Workplace
Year Founded: 2012

What We Do

Synthego is a genome engineering company enabling 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. By vertically integrating hardware, software, bioinformatics, chemistry, and molecular biology, Synthego is at the forefront of innovation advancing the next generation of medicines through providing access to genome editing at an unprecedented scale.

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Our Culture of Diversity: Different Faces from Different Places

At Synthego, our differences make us unique, help us innovate, and allow us to persevere. We stand firmly behind our values, strive to achieve representation, and celebrate diversity in perspectives and backgrounds. We welcome all team members to be their best selves as we move forward towards fulfilling our shared vision of revolutionizing genome engineering technology to help make biological therapies accessible to all patients.

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