QC Laboratory Systems Analyst

Roche • Hillsboro, OR

2d • $84,000 - $156,000 • Onsite

About The Position

Genentech’s Hillsboro Oregon campus—Hillsboro Innovative Therapies (HIT)—serves as a critical hub for emerging cell & gene therapy manufacturing. Housed within a modern 75-acre facility just outside Portland, HIT is at the forefront of advancing cell and gene therapy medicines through accelerated clinical and commercial manufacturing capabilities, aligning with Genentech’s mission to bring transformative therapies to patients. The QC Laboratory Systems Analyst is an integral part of our Quality Control (QC) team, which supports the development, implementation, and maintenance of critical digital systems to uphold our site's GxP compliance and operational excellence. As a member of this team, you will collaborate with local and global stakeholders, including IT, laboratory subject matter experts, and enterprise application teams, to drive digital transformation initiatives and ensure the integrity of laboratory systems and data. Your work will directly contribute to optimizing laboratory operations and advancing our mission to deliver high-quality products to patients. The Opportunity: As a QC Laboratory Systems Analyst, you will oversee and enhance laboratory information and ERP systems while driving the transition of test method documentation from paper-based processes to a digital platform. You will ensure data integrity, regulatory compliance, and operational efficiency at our manufacturing site.

Requirements

• Bachelor’s degree in life sciences or related discipline
• Analytical Laboratory Experience: Minimum of 4 years of 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.
• Exceptional precision in translating complex technical documentation into system configurations.
• Experience with configuring web-based enterprise applications or database-driven systems.
• Excellent communication abilities and keen awareness to spot project risks and identify escalations to senior management

Nice To Haves

• Direct experience with Cell and Gene Therapy manufacturing or testing processes.
• Familiarity with LIMS and/or ERP systems
• Experience with testing protocols and execution within a validated system lifecycle

Responsibilities

• Administer laboratory systems, manage user accounts, update settings based on established plans, and perform routine system audits to ensure compliance and optimal functionality.
• Act as the backup program lead, effectively representing QC teams in global and local system enhancement teams, governance committees, and project meetings.
• Develop, review, and manage master data for LIMS, including Raw Materials, Products, and Environmental Monitoring, as well as SAP Material Masters and Inspection Plans.
• Lead the digital transformation of paper-based test methods into structured, configurable templates within a new web-based application, engaging with laboratory subject matter experts to ensure accuracy and relevancy.
• Conduct thorough user acceptance testing (UAT) for digital templates, verifying functionality, data accuracy, and alignment with regulatory requirements.
• Collaborate with Quality Control teams, IT, and enterprise application teams to finalize, implement, and secure site acceptance for deployed method templates.
• Identify and drive resolution of laboratory system incidents while adhering to Quality policies and standards.
• Create test plans, perform, and manage qualification of laboratory equipment.
• Support laboratory continuous improvement initiatives for the QC department.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level