Principal Quality Control Specialist, Master Data

Responsibilities

• Create, update, and test Master Data and end-user system settings to enable consistent execution and reporting of QC data
• Manage and maintain complex static data including Specifications, Methods, and Sampling Plans
• Lead or participate in Quality Control investigations using Root Cause Analysis tools
• Own Corrective and Preventive Action (CAPA) plans and Change Controls
• Author, review, and approve standard operating procedures (SOPs), work instructions, and risk assessments
• Serve as a site representative for System Enhancement and User Communities of Practice
• Deliver end-user training for supported software systems including LIMS, SAP, and Empower
• Perform periodic system evaluations, audit trail reviews, and analytical equipment administration

Requirements

• B.S./B.A. in Chemistry, Biochemistry, or a relevant scientific discipline
• Minimum of 5 years of experience working in a GMP setting
• Proven experience building and maintaining complex static data in a production environment
• Working understanding of database management and relational tables
• Strong knowledge of cGMP regulations and the ability to apply quality standards to operational activities
• Excellent verbal and written communication skills

Preferred Qualifications

• Experience with Labware (LIMS), Binova (LES), SAP, Mettler Toledo LabX, Waters Empower, Veeva, or ValGenesis
• Experience in a fast-paced, greenfield start-up or large-scale manufacturing environment

About the Company

Genentech, a member of the Roche group, is a pioneer in the biotechnology industry. We are dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. Our mission is to solve the world's most complex health challenges through innovation and transformational discoveries.