Quality Control Specialist II (Contractor)

Posted 19 Days Ago
Be an Early Applicant
Brisbane, CA, USA
In-Office
Junior
Healthtech • Biotech
Spot the pattern. Treat the cancer.
The Role
Performs reagent quality control testing, documentation, non-conformance initiation, quality investigations, and QC data analysis and trending. Supports laboratory method technology transfer and validation to GMP standards. Maintains SOPs, work instructions, QC records, and forms while following CLIA laboratory and regulatory requirements. The role also involves automated liquid handling, laboratory equipment maintenance, and collaboration across disciplines in an onsite biotech laboratory.
Summary Generated by Built In

About this opportunity:

At Freenome, we are seeking a Quality Control Specialist II to help grow the Quality Control team within the Lab Operations Department. The ideal candidate is experienced in Next-Generation Sequencing (NGS) workflows, detail-orientated, and familiar working within a CLIA laboratory setting. This person will perform reagent quality control testing, author and maintain documentation, support method tech transfer, and perform tracking and trending of QC data. You are passionate about contributing to developing life-saving diagnostics through early cancer detection, and you will have a significant impact on the continued growth of an organization dedicated to changing the entire landscape of cancer.

The role reports to the Quality Control Supervisor. This role will be an onsite role based in our Brisbane, California headquarters.

What you’ll do:

  • Perform reagent quality control testing per Standard Operating Procedures 
  • Author, review, and maintain documentation, such as Standard Operating Procedures, Work Instructions, QC Records and Forms for regulatory compliance
  • Initiate non-conformances for any process deviations or reagent quality control failures
  • Participate in the investigation of reagent and consumable quality issues
  • Record, analyze, and trend QC data using good documentation practices
  • Support the tech transfer and validation of QC test methods to GMP standards
  • Build and maintain strong knowledge of fundamentals and regulatory requirements applicable to laboratory operations and quality control

Must haves:

  • Bachelor’s degree with at least two years of working experience or Master’s degree in Chemistry, Biochemistry, Biology, Bioengineering or similar field
  • Knowledge of/experience with Quality Control and Quality Assurance principles, including GMP/ISO
  • Technical writing experience, including Standard Operating Procedures, Work Instructions, QC Records and Forms
  • Hands-on experience with automated liquid handlers (e.g., Hamilton, Bravo)
  • Experience with performing routine laboratory equipment maintenance
  • Exceptional attention to detail and commitment to producing high-quality data
  • Excellent interpersonal and communications skills, and proven ability to work with team members in the same and adjacent disciplines

Nice to haves:

  • Experience maintaining 5S workplace organization principles in a laboratory
  • Experience with softwares such as LIMS, Netsuite, Softmax Pro, and Bartender
  • Proficiency with Microsoft Excel, Word, and data analysis tools

Additional information:

Contractors may be hired through a third-party provider and will be considered contingent workers. We invite you to check out our career page @ freenome.com/job-openings/ for additional company information.  

Freenome is proud to be an equal opportunity employer and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Applicants have rights under Federal Employment Laws.  

  • Family & Medical Leave Act (FMLA)
  • Equal Employment Opportunity (EEO)
  • Employee Polygraph Protection Act (EPPA)

California applicants please review the CCPA Notice at Collection here:

  • California Consumer Privacy Act (CCPA)

#LI-ONSITE

Skills Required

  • Bachelor’s degree in Chemistry, Biochemistry, Biology, Bioengineering, or a similar field, plus at least two years of work experience
  • Master’s degree in Chemistry, Biochemistry, Biology, Bioengineering, or a similar field
  • Knowledge of or experience with Quality Control and Quality Assurance principles, including GMP and ISO
  • Technical writing experience authoring Standard Operating Procedures, Work Instructions, QC Records, and Forms
  • Hands-on experience with automated liquid handlers such as Hamilton or Bravo
  • Experience performing routine laboratory equipment maintenance
  • Exceptional attention to detail and commitment to producing high-quality data
  • Excellent interpersonal and communication skills, with ability to collaborate across disciplines
  • Experience maintaining 5S workplace organization principles in a laboratory
  • Experience with LIMS, NetSuite, SoftMax Pro, and BarTender
  • Proficiency with Microsoft Excel, Microsoft Word, and data analysis tools
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The Company
HQ: Brisbane, CA
372 Employees
Year Founded: 2014

What We Do

Freenome is on a mission to empower everyone with the tools they need to detect, treat, and ultimately prevent cancer. We have pioneered the most comprehensive multiomics platform for early cancer detection through a routine blood draw. By combining deep expertise in molecular biology with advanced computational biology and machine learning techniques to recognize disease-associated patterns among billions of circulating, cell-free biomarkers, we are developing simple and accurate blood tests for early cancer detection and integrating the actionable insights into health systems to operationalize a machine learning feedback loop between care and science. Our recent $270 Million Series C brings our financing to over $500 million from investors, including; Bain Capital, Perceptive Advisors, RA Capital, Polaris Partners, Andreessen Horowitz, funds and accounts advised by T. Rowe Price Associates, Inc., GV (formerly Google Ventures), Roche Venture Fund, Kaiser Permanente Ventures, American Cancer Society’s BrightEdge Ventures, Data Collective Venture Capital, Novartis and Verily Life Sciences.

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