Principal Quality Control Specialist, Microbiology

Roche•Holly Springs, NC

1d•$90,000 - $167,000•Onsite

About The Position

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. Your Opportunity: We are seeking a QC Principal Specialist, Microbiology to support the establishment of the Microbiology Laboratory at our Greenfield Holly Springs facility. During the site start-up phase, this role will be key to the development of the microbiology laboratory quality system, test method implementation, laboratory operations, and establishment of Contract Laboratory Operations (CLO) . You will design efficient microbiology operations through the integration of simplified processes, high level of automation/digital solutions and Rapid Micro technology. You will be a key partner to Operations and Quality in establishing an efficient, robust, and compliant Environmental and Utility monitoring program. As the site transitions into routine operations the role will evolve into routine microbiology laboratory duties with full ownership of EM and Utility reports, a key Microbiology SME for the site and represent Holly Springs in the global microbiology forums.

Requirements

Bachelor’s degree in Microbiology, Biology or a related life sciences field with a minimum 8-11 years in a GMP laboratory environment (6-8 years with Masters, 3-6years with PhD)
In depth knowledge and experience of Utility and Environmental monitoring programs from sampling through to report authoring.
Technical proficiency in Rapid Sterility platforms, Genetic ID, Bioburden, and Endotoxin.
Extensive experience with LIMS and the use of automated/digital laboratory systems.
Proven experience managing Deviations, CMRs, and CAPAs within a regulated QMS (e.g., TrackWise, Veeva).
Excellent attention to detail and strong analytical problem-solving skills.
Experience presenting during regulatory, or internal inspections.
Strong communication and collaboration skills to work effectively with cross-functional and Global teams.

Responsibilities

QC Micro lead on the environmental monitoring program strategy, risk assessment, sampling, testing and PQ.
Provide technical oversight and onboarding of Contract Laboratory Operations (CLO) during the start-up phase
Support the design and construction phase of the Microbiology laboratories and equipment selection/qualification.
Establish qualified microbiology release testing including but not limited to Rapid Sterility, Genetic ID, Bioburden and Endotoxin.
Establish the digital solution for the Microbiology Testing labs supported by the IT project team and global QC network.
Own the EM and Utility report lifecycle, performing trend analysis and authoring site-level periodic reports to monitor facility performance.
QC Microbiology SME for the site and represent Holly Springs in Global Microbiology Forums to align with network best practices and Annex 1 requirements.
Own Quality Management System records for Microbiology , including Deviations, Change Management Records (CMR), and CAPA.
Deliver the ongoing training and professional development of the QC Microbiology team to ensure technical proficiency and "Right First Time" execution.
Present Microbiology topics to regulatory (FDA/EMA) and internal inspectors.
Continuously optimize lab performance through Lean coaching.