Principal Quality Control Specialist, Master Data (Biotech)

TL;DR

Principal Quality Control Specialist, Master Data (Biotech): Creating and sustaining a fully digital QC laboratory for high-volume Drug Product manufacturing with an accent on Master Data management and QC IT systems. Focus on designing and testing system settings in LIMS, SAP, and LES to ensure consistent data collection and reporting.

Location: Onsite in Holly Springs, NC, USA

Salary: $98,000 - $182,000

Company

hirify.global, a member of the Roche group, is a pioneer in the biotechnology industry dedicated to developing groundbreaking medicines for serious and life-threatening diseases.

What you will do

• Create and maintain Master Data, including specifications, methods, and sampling plans, to support QC operations.
• Collaborate with cross-functional teams such as Database Developers, Business Analysts, and Product Technical Leads.
• Administer analytical equipment and manage software systems including Labware (LIMS), Binova (LES), SAP, and Waters Empower.
• Lead Quality Control investigations using Root Cause Analysis tools and implement CAPAs and Change Controls.
• Develop and deliver end-user training for site IT systems and act as a Subject Matter Expert.
• Author and approve SOPs, work instructions, monitoring protocols, and risk assessments.

Requirements

• B.S./B.A. degree in Chemistry, Biochemistry, or a relevant scientific discipline.
• Minimum of 5 years of experience in a GMP setting.
• Proven experience building and maintaining complex static data in a production environment.
• Working understanding of database management and relational tables.
• Sound knowledge of cGMP regulations and the ability to apply quality standards to operational activities.
• Must be based in or able to work onsite in Holly Springs, NC.

Culture & Benefits

• Opportunity to launch a state-of-the-art $2B greenfield facility from the ground-up.
• Fast-paced, entrepreneurial environment with a high level of accountability.
• Focus on innovation through advanced automation, robotics, and real-time data analytics.
• Comprehensive corporate benefits package.
• Collaborative work environment within a global leader in biotech.