QC Specialist, Master Data

Overview

Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products. The Operations organization at HTO is divided into three value streams, which combine to produce millions of units of life‑saving medicine every year to patients around the world.

As a member of the HTO QC Team, you will manage simple to moderately complex sets of Master Data that support QC operations. Your day‑to‑day responsibilities will include:

• Maintaining and improving the contemporary relevance of QC Master Data.
• Conducting minor deviation investigations, owning Corrective and Preventive Actions (CAPAs) and Change Request Actions.
• Performing periodic reporting, data review, and generation of certificates of test/analysis; conducting direct material release and reviewing/generating drug product Certificates of Analysis.
• Administering analytical equipment and participating in minor Quality Control Investigations (e.g., out of specifications, expectations, action limits, process deviations) using Root Cause Analysis tools.
• Collaborating with stakeholders to identify and execute Corrective and Preventive Action Plans, completing assigned actions through self or others.
• Authoring, reviewing, and approving business process and compliance documents such as standard operating procedures, work instructions, monitoring protocols, reports, gap assessments, and risk assessments.
• Representing the site on System Enhancement Teams and User Communities of Practice Teams; communicating system changes and best practices to local users and maintaining continuous end‑user training materials for supported systems.

Supported software systems include:
Labware LIMS, Biovia, Molecular Devices Soft Max Pro, SAP, Mettler Toledo LabX, Waters Empower Chromatography Data System, Veeva, and Val Genesis.

• Bachelor’s of Science degree with 4–7 years of experience in the pharmaceutical industry, quality control and/or database management, or 8+ years of experience with an Associates/Vocational Degree.
• Minimum of 3 years of experience working in a cGMP or similarly regulated environment.
• Working understanding of database management/relational tables, Operational Excellence tools, cGMP regulations, and industry guidelines related to biological processing.
• Experience building reporting tools such as Tableau dashboards is preferred.
• Strong verbal and written communication skills, ability to summarize problems and drive informed decisions, and a curious, open mindset for fostering effective cross‑functional teams.

The role is site‑based in a flexible open‑space environment with random visits to a QC laboratory that requires laboratory gowning (lab coat, goggles, gloves). Duties involve extended computer use (6–8 hours) and may require lifting up to 25lbs or working with hazardous materials and chemicals.

Salary range for the Oregon location: $77,770 to $144,430, adjusted for experience, qualifications, and geographic location. An annual discretionary bonus may be available based on individual and company performance. This position also qualifies for company benefits.

Genentech is an equal opportunity employer. The company policy prohibits unlawful discrimination, including discrimination on the basis of protected veteran status, disability status, and in compliance with all federal, state, and local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing the Accommodations for Applicants form.