QC Lab System Specialist

Job Role: QC Lab System Specialist

Location: Hillsboro Oregon

Duration: 12+ months

Role Description: This role is critical in transitioning our GxP test method documentation from paper-based records to a digital platform. The analyst will focus on the development, configuration, and site acceptance of test method templates, with potential involvement in other critical digital systems like LIMS, ERP, and equipment integration.

Key Responsibilities:

Test Method Template Development: Translate existing paper-based site analytical test methods into structured, configurable digital templates within the new web-based application. Engage with laboratory SMEs during development cycles.

System Configuration: Configure test method templates to accurately reflect the sequential steps, required data inputs, calculations, and approval workflows of the site's analytical testing processes, ensuring GXP compliance.

Required Experience & Skills:

• Analytical Laboratory Experience: Minimum of 2 years of hands-on experience working in an analytical testing lab environment (e.g., QC, R&D) in a regulated industry (e.g., pharmaceutical, biotech, cell and gene therapy).
• Digital System Implementation: Proven experience supporting the implementation or upgrade of a digital system (e.g., LIMS, ELN, QMS) in a GxP environment.
• GXP Knowledge: Strong working knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP), particularly as they relate to data integrity and documentation within a regulated manufacturing setting.
• Attention to Detail: Exceptional precision in translating complex technical documentation into system configurations.
• Software Proficiency: Experience with configuring web-based enterprise applications or database-driven systems.
• Preferred Experience & Skills:
• Experience with Cell and Gene Therapy manufacturing or testing processes

Education: At least a bachelor s degree (or equivalent experience) in Computer Science, Software/Electronics Engineering, Information Systems, or a closely related field is required for the project