Quality Control Specialist II (Contractor)

The role

The Quality Control Specialist II will perform reagent quality control testing and maintain documentation. This role supports method tech transfer and performs tracking and trending of QC data within the Lab Operations Department.

What you will do

• 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

Required 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

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

Before you apply

• Contractors may be hired through a third-party provider and will be considered contingent workers

About the company

Freenome is an organization dedicated to changing the landscape of cancer through early cancer detection diagnostics.