Quality Control Specialist II

Regulatory Jobs; Brisbane (CA); On-site; USD 70,000 - 100,000; Full time

Job summary

Freenome is seeking a Quality Control Specialist II to advance the QC program in the Lab Operations Department at our Brisbane, California headquarters. The role emphasizes NGS QC testing, documentation, and regulatory compliance within a CLIA environment, reporting to the QC Supervisor.

You will perform QC tests, author SOPs and forms, drive investigations of non-conformances, trend QC data, and support transfer and validation of QC methods to GMP standards in an onsite team setting.

Qualifications

• 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 GMP/ISO quality systems and QA principles
• Technical writing experience including SOPs, Work Instructions, QC Records and Forms
• Hands-on experience with automated liquid handlers (Hamilton, Bravo)
• Experience with routine laboratory equipment maintenance
• Strong attention to detail and commitment to high-quality data
• Excellent interpersonal and communications skills and ability to work with cross-disciplinary teams

Responsibilities

• Perform reagent quality control testing per SOPs
• Author, review, and maintain QC documentation for regulatory compliance
• Initiate non-conformances for process deviations or QC failures
• Investigate reagent and consumable quality issues
• Record, analyze, and trend QC data following good documentation practices
• Support tech transfer and validation of QC methods to GMP standards
• Maintain knowledge of regulatory requirements for lab operations and quality control

Skills

Quality Control

Documentation

Attention to detail

Interpersonal skills

Data analysis

Education

Bachelor’s degree in Chemistry, Biochemistry, Biology, Bioengineering or related field

Master’s degree in Chemistry, Biochemistry, Biology, Bioengineering or related field

Tools

Hamilton liquid handler

Bravo liquid handling system

LIMS

Netsuite

Softmax Pro

Bartender

Job description

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)

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