Quality Control Specialist - Contractor

Why join Freenome?

Freenome is a high-growth biotech company on a mission since 2014 to create tools that empower everyone to prevent, detect, and treat their disease. 

To achieve this mission, Freenome is developing next-generation blood tests to detect cancer in its earliest, most treatable stages using our multiomics platform and machine learning techniques. Our first blood test will detect early-stage colorectal cancer and advanced adenomas.

To fight the war on cancer, Freenome has raised more than $1.1B from leading investors including a16z, GV (formerly Google Ventures), T. Rowe Price, BainCapital, Perceptive Advisors, RA Capital Management, Roche, Kaiser Permanente Ventures, and the American Cancer Society’s BrightEdge Ventures.

About this opportunity:

As a Quality Control Specialist, you will join our Operations department and be part of a highly collaborative team to make an immediate impact on early cancer detection.  The primary focus of the position is to perform QC testing needs for Freenome's multiomics IVD product. These testing can include NGS-based methods and immunoassays. Secondary to the role is documentation; the work requires keeping meticulous and organized records, excellent attention to detail, and the ability to prioritize and be flexible with multiple tasks and schedules. 

This position will report to the QC manager.

What you’ll do:

• Perform release and stability testing of non-clinical, consumables, and reagent materials according to procedures
• Review and maintain documentation, such as Standard Operating Procedures, Work Instructions, QC Records/Forms, Non-conformances, and other necessary documentation for regulatory compliance using good documentation practices. 
• Monitor QC data
• Investigate material quality issues
• Prepare material quality reports by collecting, analyzing, and summarizing information and trend
• Build and maintain strong knowledge of fundamentals and regulatory requirements  applicable to laboratory operations and quality control

Must haves:

• Bachelor’s or Master’s degree in Chemistry, Biochemistry, Biology, Bioengineering, or a similar field
• Minimum of 2+ years of industry experience in Operations/Quality Control
• Knowledge of/experience with Quality Control and Quality Assurance principles, including GMP/ISO
• Strong hands-on experience with pipetting and plasma handling is required
• Exceptional attention to detail and commitment to producing high-quality data
• Willingness to learn and follow regulatory guidelines while working in a fast-paced environment
• Strong communication and organizational skills
• Strong interpersonal skills and desire to work within a highly collaborative team; adept at building cross-functional relationships with individuals from diverse backgrounds

Nice to haves:

• Knowledge of/experience with MS Office, LIMS, Netsuite, Softmax Pro, laboratory automation, NGS, immunoassay, etc is a plus

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 @ https://careers.freenome.com/ 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)

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