Quality Control Specialist I (Contractor)

At Freenome, we are seeking a Quality Control Specialist I to help grow the Quality Control team within the Lab Operations Department.

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.

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 in Chemistry, Biochemistry, Biology, Bioengineering or similar field
• Ability to follow written procedures and work in a regulated environment
• Ability to complete documentation in an accurate and timely manner in order to maintain regulatory compliance
• Strong attention to detail and time management skills
• Excellent interpersonal and communications skills in order to work in a highly cross-functional environment

Nice to Have

• Experience with performing routine laboratory equipment maintenance
• Hands-on experience with automated liquid handlers (e.g., Hamilton, Bravo)
• Proficiency with Microsoft Excel, Word, and PowerPoint