**Overview** **Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO** The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki. **Join us** We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America. The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States. **External US** **About This Role** Sr. Specialist 1, QC Lab Support works under moderate supervision, supporting and participating in QC activities related to investigations, deviations, OOS/OOT, CAPAs, and Change Controls. This role assists in creating and maintaining GMP documents and processes, collaborating with stakeholders and QA. This role contributes to customer contact and CLO communication to support QC capabilities in delivering materials and results. This role helps ensure QC compliance with policies and procedures. This role participates in project management and process improvement initiatives, developing skills in risk assessment. The role requires the ability to work effectively both independently and as part of a team, with growing cross-functional collaboration. • Assists in technical projects and problem-solving under close supervision, learning to apply analytical and QC improvement methodologies. Begins to contribute to the creation and review of controlled GMP documents, including basic protocols and reports, under guidance from more experienced team members. • Participates in cross-functional team meetings to gain exposure to QC's role in various business processes. Supports method troubleshooting efforts by collecting data and assisting more senior team members. • Participates in change control processes and compliance-related documentation. Follows established procedures and guidelines to ensureadherence to quality standards and global QC vision. • Develops awareness of quality systems and begins to identify potential areas for improvement under supervision. • Assists in the implementation of solutions developed by more experienced team members. • Shadows more experienced team members in CLO communication roles, learning about issues such as OOS's and deviations. Helps compile data for performance and status reports. • Observes customer interactions led by senior team members, gaining exposure to topics such as changes, deviations, or other issues. • Assists in gathering data for status overviews and reports. • Accurately documents sample receipt, storage, and movement in Labware LIMS and/or internal sample chain of custody forms or logbooks. • Identifies and escalates sample issues to appropriate team members or supervisors. • Performs other entry-level duties as assigned, focusing on developing technical skills and understanding of QC processes. • Performs other duties, as assigned **Minimum Requirements** • Bachelor’s degree in science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 3+ years of relevant experience OR • Master’s degree in science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 1 year of relevant experience • 1- 3 years relevant experience, experience in a GMP environment **Preferred Requirements** • Experience with KNEAT software • Experience qualifying analytical instruments **Working & Physical Conditions** Ability to discern audible cues. Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. Ability to ascend or descend ladders, scaffolding, ramps, etc. Ability to stand for prolonged periods of time up to 60 minutes. Ability to sit for prolonged periods of time up to 60 minutes. Ability to conduct activities using repetitive motions that include wrists, hands or fingers. Ability to conduct work that includes moving objects up to 10 pounds. Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. _FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email_ FDBN_PNC@fujifilm.com _._ _To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid._ **Job Locations** _US-NC-Holly Springs_ **Posted Date** _4 weeks ago_ _(11/20/2024 11:24 AM)_ **_Requisition ID_** _2024-32429_ **_Category_** _Quality Control_ **_Company (Portal Searching)_** _FUJIFILM Diosynth Biotechnologies_