Quality Control Specialist II – NGS Lab, Onsite, GMP

Regulatory Jobs; Brisbane (CA); Sur place; USD 70 000 - 100 000; Plein temps

Résumé du poste

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

Responsabilités

• 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

Connaissances

Quality Control

Documentation

Attention to detail

Interpersonal skills

Data analysis

Formation

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

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

Outils

Hamilton liquid handler

Bravo liquid handling system

LIMS

Netsuite

Softmax Pro

Bartender

Description du poste

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.