Principal Quality Control Specialist, Direct Materials
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: In this exciting role, you will be a member of a collaborative team that creates outcomes that matter for patients, customers and the company. This Direct Material position will join the exciting and fast-paced Quality Control Operations team in Holly Springs. You will establish the Direct Materials testing laboratory with the support of the wider start up project team. You will perform routine testing/review/approval/coordination of excipients, primary and secondary packaging. You will establish, implement and use SOPs, specifications, and testing methods in full compliance with cGMP regulations and evolving expectations You will provide technical input to ensure rapid resolution of any operational/technical issues (discrepancies and deviations) You will develop, provide and receive training You will lead and/or perform analytical activities (e.g., assay transfer and assay validation) to meet project timelines You will support internal and external audits and regulatory inspections You will perform technical review of data and assess against established acceptance criteria You will identify discrepancies and provide input to quality investigations and CAPA initiatives as needed You will participate in and/or lead project teams and process improvements initiatives You will establish work priorities to meet targets and timelines; manage competing priorities You will serve as representative on cross-functional and multi-site teams You will serve as a technical subject matter expert (SME) in support of department functions You will notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
Requirements
- 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 sound knowledge of cGMPs or equivalent Regulations.
- You must have strong verbal and written communication skills.
- You must have the ability to interpret and apply quality standards to operational activities.
Nice To Haves
- You have administration experience in QC Software Applications.
- You have experience with the implementation of a Greenfield QC Laboratory
Responsibilities
- Establish the Direct Materials testing laboratory with the support of the wider start up project team.
- Perform routine testing/review/approval/coordination of excipients, primary and secondary packaging.
- Establish, implement and use SOPs, specifications, and testing methods in full compliance with cGMP regulations and evolving expectations
- Provide technical input to ensure rapid resolution of any operational/technical issues (discrepancies and deviations)
- Develop, provide and receive training
- Lead and/or perform analytical activities (e.g., assay transfer and assay validation) to meet project timelines
- Support internal and external audits and regulatory inspections
- Perform technical review of data and assess against established acceptance criteria
- Identify discrepancies and provide input to quality investigations and CAPA initiatives as needed
- Participate in and/or lead project teams and process improvements initiatives
- Establish work priorities to meet targets and timelines; manage competing priorities
- Serve as representative on cross-functional and multi-site teams
- Serve as a technical subject matter expert (SME) in support of department functions
- Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
