Senior Principal Quality Control Specialist (Master Data)

Location: On site in Holly Springs, North Carolina, United States. The role involves working in QC laboratories and a flexible open-space environment. No relocation benefits are available.

Salary: $128,000–$238,000 per year, plus a discretionary annual bonus may be available.

Company

hirify.global, a member of the Roche group, develops medicines and biotechnology solutions for serious and life-threatening diseases.

What you will do

• Create, update, test, and maintain QC master data and end-user system settings.
• Support a fully digital QC laboratory across Labware LIMS, Binova LES, SAP, LabX, Waters Empower, Veeva, and ValGenesis.
• Own deviation investigations, CAPAs, change requests, periodic reporting, system evaluations, audit trail reviews, and analytical equipment administration.
• Develop and deliver end-user training and communicate system changes and best practices to local users.
• Author, review, and approve SOPs, work instructions, monitoring protocols, gap assessments, and risk assessments.
• Participate in cross-functional teams supporting safety, quality, delivery, engagement, and cost objectives.

Requirements

• B.S. or B.A. in Chemistry, Biochemistry, or a related scientific discipline.
• At least eight years of experience in a GMP environment.
• Proven experience building and maintaining complex static data, including specifications, methods, and sampling plans, in a production environment.
• Working knowledge of database management and relational tables, preferably with Labware, Binova, SAP, Mettler Toledo LabX, Waters Empower, or similar cGMP QC systems.
• Sound knowledge of cGMPs or equivalent regulations, with the ability to apply quality standards to operational activities.
• Strong verbal and written communication skills; ability to work with analytical instruments and computerized systems for extended periods.

Culture & Benefits

• Work in a new $2 billion greenfield facility planned for launch in 2028.
• Support advanced automation, robotics, digital tools, real-time analytics, and high-volume drug product manufacturing.
• Work in a fast-paced, entrepreneurial environment with a high level of accountability and cross-functional collaboration.
• QC laboratory work requires gowning, including a lab coat, eye protection, and gloves.
• The role may involve lifting up to 25 pounds and handling hazardous materials and chemicals.
• hirify.global offers employee benefits and is an equal opportunity employer.