QC Specialist II — NGS & GMP Lab QC Contract

Freenome

Brisbane (CA)

On-site

USD 70,000 - 90,000

Full time

13 days ago

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Job summary

Freenome is seeking a Quality Control Specialist II (Contractor) in Brisbane, CA to support QC testing and regulatory documentation within a CLIA-compliant lab. You will drive quality data, assist with method transfer, and ensure documentation aligns with GMP/ISO standards.

The role emphasizes hands-on QC testing, data trending, and cross-functional collaboration with lab operations, enabling advancement in cancer diagnostics through rigorous quality practices.

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/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

Responsibilities

  • 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

Skills

Quality Control
Quality Assurance
Technical writing
Automated liquid handling
Lab equipment maintenance
Attention to detail
Communication

Education

Bachelor’s degree
Master’s degree

Tools

LIMS
Netsuite
Softmax Pro
Bartender
Excel
Word

Job description

Freenome is seeking a Quality Control Specialist II (Contractor) in Brisbane, CA to support QC testing and regulatory documentation within a CLIA-compliant lab. You will drive quality data, assist with method transfer, and ensure documentation aligns with GMP/ISO standards.

The role emphasizes hands-on QC testing, data trending, and cross-functional collaboration with lab operations, enabling advancement in cancer diagnostics through rigorous quality practices.

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