Principal Quality Control Specialist, Master Data

Welcome to Holly Springs, North Carolina- home to Roche/Genentech's largest-ever investment: a $2B greenfield start-up where next-generation technology, high-performing teams and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing.

The facility's core is defined by Innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant meets today's demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines and is scalable to grow with the portfolio, which focuses on next-generation metabolic medicines specifically targeting the global obesity epidemic and Type 2 diabetes. This is a fast-paced, entrepreneurial environment with a high-level of accountability, with planned launch in 2028.

Are you a problem-solver and change-agent who thrives in a Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to launch a state-of-the-art facility from the ground-up and shape the culture of our organization for the next generation.

Join us in Holly Springs, where you won't just build a plant-you will build the future of medicine.

The Opportunity:

The Holly Springs QC Team is seeking an individual to create and sustain a fully digital QC laboratory, key to this is simple to moderately complex sets of Master Data that support QC operations. This role will collaborate with internal and external departments (e.g. QC Operations, Database System Developers, Business Analysts, Manufacturing, Packaging, External Quality, Control System Scientists, Product Technical Leads etc.) to maintain and improve contemporary relevance of QC Master Data. This role will have a deep understanding of how QC master data is utilized and how it can be improved. As a key SME in QC IT systems the role will develop and deliver end user training for the site. The role will own deviation investigations, Corrective and Preventive Actions (CAPAs), Change Requests, perform periodic reporting, periodic system evaluations, audit trail review and analytical equipment administration.

• You will create, update and test Master Data and end-user defined system settings to enable consistent execution, collection, transaction, storage, analysis, and reporting of QC data. Software Systems include: Labware (LIMS), Binova (LES), SAP, Mettler Toledo LabX, Waters Empower Chromatography Data System, Veeva, and ValGenesis.
• You will be the site representative on System Enhancement and User Communities of Practice Teams, communicating system changes and best practices to local system users
• You will be accountable for end user training for supported systems.
• You will lead or participate in Quality Control Investigations using established Root Cause Analysis tools and generating data-based impact assessments within established timelines.
• You will own Corrective and Preventive Action Plans and Change Controls.
• You will author, review, and/or approve standard operating procedures, work instructions, monitoring protocols, monitoring reports, gap assessments, and risk assessments.
• You will participate in cross functional teams that ensure safety, quality, delivery, engagement and cost objectives are sustained/exceeded.

• You have a B.S./B.A. degree in Chemistry, Biochemistry, or relevant scientific discipline and a minimum of five years of experience in a GMP setting.
• You have a proven experience building and maintaining complex static data (Specifications, Methods, Sampling Plans) in a production environment.
• You possess a working understanding of database management/relational tables, preferably with experience working with Labware (LIMS), Binova (LES), SAP, Mettler Toledo LabX, Waters Empower Chromatography Data System or similar cGMP QC systems.
• You have sound knowledge of cGMPs or equivalent Regulations.
• You must have the ability to interpret and apply quality standards to operational activities.
• You must have strong verbal and written communication skills.

Work Environment/Physical Demands/Safety Considerations

• You will be working on site in a flexible open space work environment and QC laboratories requiring gowning (lab coat, eye protection, gloves)
• You will work on/interact with analytical instruments and computerized systems/screens for long periods of time (6-8 hours)
• You may be required to lift up to 25lbs
• You may have to work with hazardous materials and chemicals.