Description
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.
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
Requirements
- 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 Have
- 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