Hiring: Senior Specialist 2, Quality Control Instrumentation Company: FUJIFILM Biotechnologies Location: Holly Springs, NC Job Posted Time: 2026-09-10 13:35:12 Target Skills & Keywords : Quality Assurance, Regulatory Compliance About the job Experience: •3+ years of experience in a GMP environment Required Skills: •Manage the qualification, routine operation, maintenance, continuous improvement, and decommissioning of QC analytical instrumentation. •Ensure QC equipment and instruments adhere to applicable regulatory guidelines, data integrity expectations, and site policies. •Develop, author, and review SOPs, technical reports, user requirements, functional specifications, and KNEAT protocols and reports. •Lead data integrity initiatives for analytical instruments, including periodic reviews to ensure ongoing compliance. •Recommend user roles and privileges to uphold data integrity; design instrument operating instructions and preventive maintenance plans. •Execute and evaluate periodic reviews of QC instruments and their control software; monitor ongoing performance and drive process improvements. •Partner with vendors to plan and oversee instrument maintenance activities. •Initiate and oversee follow-up on excursions and deviations; manage corrective and preventive actions (CAPAs) related to analytical instruments. Qualifications: •Own a mission-critical instrument program and make measurable impact on data integrity, compliance, and QC reliability. •Shape best practices, steward continuous improvement, and partner across the organization and with external vendors. •Develop as a trusted advisor who solves complex challenges and advances operational excellence. •Includes periodic on-call and weekend support, as needed. •Ready to lead the instruments that power high-quality science? Apply now. •Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. •If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com). •5+ years of experience OR Master’s in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 3+ years of experience OR PhD in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 1+ years of experience Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!