QC Specialist I - NGS Lab, Onsite & Regulated

Regulatory Jobs; Brisbane (CA); Vor Ort; USD 70.000 - 90.000; Vollzeit

Zusammenfassung

Freenome is seeking a Quality Control Specialist I to join the Lab Operations team at our Brisbane, CA headquarters. The role focuses on reagent QC testing, documentation, and data trending to support GMP-compliant QC methods in a CLIA environment.

You will collaborate cross-functionally, initiate non-conformances, and help transfer QC methods to GMP standards, contributing to high-quality diagnostics development.

Qualifikationen

• Bachelor’s degree in Chemistry, Biochemistry, Biology, Bioengineering or similar field.
• Ability to follow written procedures in a regulated environment.
• Ability to complete documentation accurately and timely to maintain regulatory compliance.
• Strong attention to detail and time management.
• Excellent interpersonal and communications skills in cross-functional environments.

Aufgaben

• Perform reagent quality control testing per Standard Operating Procedures.
• Author, review, and maintain documentation (SOPs, Work Instructions, QC Records/Forms) for regulatory compliance.
• Initiate non-conformances for any process deviations or reagent QC failures.
• Participate in investigation of reagent and consumable quality issues.
• Record, analyze, and trend QC data using good documentation practices.
• Support tech transfer and validation of QC test methods to GMP standards.
• Build and maintain knowledge of regulatory requirements applicable to laboratory operations and quality control.

Kenntnisse

Attention to detail

Time management

Written procedures

Interpersonal communication

Ausbildung

Bachelor's degree in Chemistry, Biochemistry, Biology, Bioengineering or similar

Tools

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Automated liquid handlers (Hamilton, Bravo)

Jobbeschreibung

Freenome is seeking a Quality Control Specialist I to join the Lab Operations team at our Brisbane, CA headquarters. The role focuses on reagent QC testing, documentation, and data trending to support GMP-compliant QC methods in a CLIA environment.

You will collaborate cross-functionally, initiate non-conformances, and help transfer QC methods to GMP standards, contributing to high-quality diagnostics development.