Senior Specialist 1, Quality Control Lab Support

Fujifilm•Holly Springs, NC

5d•Onsite

About The Position

The Senior Specialist 1, Quality Control 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. FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.”

Requirements

Bachelor's degree in science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 2+ years of relevant experience OR Master's degree in science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 0 years of relevant experience
1- 3 years relevant experience, experience in a GMP environment
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.
Will work in small and/or enclosed spaces.
Will work in heights greater than 4 feet.

Nice To Haves

Experience with KNEAT software
Experience qualifying analytical instruments

Responsibilities

Initiates and authors deviations, CAPA's, and change controls for the functional groups within QC
Initiates and supports actions for implementation of solutions, process improvements and CAPAs
Participates in customer interactions to gain exposure to topics such as changes, deviations, or other issues and gathers data for status overviews and reports deviations upon completion of training and observation
Reviews and updates stability protocols, sample plans, and specifications related to Drug Substance and Drug Product updates for controlled GMP documents related to sample plans and specifications
Coordinates technical projects and performs problem-solving learning to apply analytical and QC improvement methodologies
Participates in cross-functional team meetings to gain exposure to QC's role in various business processes
Supports QC laboratories in method troubleshooting efforts by collecting data and assisting team members
Owns changes in support of QC laboratories through the change control processes, and compliance-related documentation
Performs continuous improvement activities by developing awareness of quality systems and identifies potential areas for improvement
Provides recommendations to management on KPI's as needed to evaluate the changes made
Assists team members in Contract Laboratory (CLO), communication roles, learning about issues such as OOS's and deviations and compiles data for performance and status reports
Interacts with clients as needed to support change controls and deviations
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 parties
Performs other duties, as assigned