Quality Control Specialist I

Regulatory Jobs; Brisbane (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

Freenome is seeking a Quality Control Specialist I to join the Lab Operations team at our Brisbane, CA headquarters. The role focuses on reagent QC testing, documentation, and data trending to support GMP-compliant QC methods in a CLIA environment.

You will collaborate cross-functionally, initiate non-conformances, and help transfer QC methods to GMP standards, contributing to high-quality diagnostics development.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Biology, Bioengineering or similar field.
• Ability to follow written procedures in a regulated environment.
• Ability to complete documentation accurately and timely to maintain regulatory compliance.
• Strong attention to detail and time management.
• Excellent interpersonal and communications skills in cross-functional environments.

Responsibilities

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

Skills

Attention to detail

Time management

Written procedures

Interpersonal communication

Education

Bachelor's degree in Chemistry, Biochemistry, Biology, Bioengineering or similar

Tools

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Automated liquid handlers (Hamilton, Bravo)

Job description

About this opportunity:

At Freenome, we are seeking a Quality Control Specialist I 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 in Chemistry, Biochemistry, Biology, Bioengineering or similar field
  
• Ability to follow written procedures and work in a regulated environment
  
• Ability to complete documentation in an accurate and timely manner in order to maintain regulatory compliance
  
• Strong attention to detail and time management skills
  
• Excellent interpersonal and communications skills in order to work in a highly cross-functional environment
  

Nice to haves:

• Experience with performing routine laboratory equipment maintenance
• Hands-on experience with automated liquid handlers (e.g., Hamilton, Bravo)
  
• Proficiency with Microsoft Excel, Word, and PowerPoint
  

Additional information:

Contractors may be hired through a third-party provider and will be considered contingent workers.

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)

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