What are the responsibilities and job description for the Senior Specialist 2, QC Instrumentation position at FUJIFILM Biotechnologies?
Join a high-impact Quality Control team where you’ll own the lifecycle of critical analytical instruments that keep life-changing therapies moving. As Sr. Specialist 2, QC Instrumentation, you will lead the routine operation, qualification, maintenance, continuous improvement, and decommissioning of QC analytical instrumentation with minimal supervision—while ensuring data integrity and regulatory compliance at every step. You’ll be the go-to expert for instrument performance and reliability, partnering across functions and with external vendors to solve complex problems, drive process improvements, and uphold world-class standards. This role includes periodic on-call and weekend support, as needed.
What you’ll do
- 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.
- Provide guidance to stakeholders and address issues related to QC analytical instruments; manage a variety of routine tasks while balancing project priorities.
- Collaborate with cross-functional partners—including end users, Validation, Labware Specialists, and Quality Assurance—to ensure effective, compliant instrument operations.
- Perform other duties, as assigned.
How you’ll work
- Tackle problems of diverse scope, analyzing limited information and precedent to devise solutions and adapt approaches.
- Apply sound evaluation, judgment, and interpretation to select the right course of action.
- Operate independently with work reviewed at critical points.
- Build strong relationships and networks with senior internal/external partners—often advising others on complex topics and tailoring communication to differing audiences.
Minimum education and experience requirements
- Bachelor’s in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 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.
- 3 years of experience in a GMP environment.
- Prior hands-on experience with analytical instrumentation, including but not limited to UPLC/HPLC (Ultra/High-Performance Liquid Chromatography), Capillary Electrophoresis/Imaged Capillary Isoelectric Focusing (iCIEF), Gel Electrophoresis/Western Blot, Plate Readers, qPCR (Quantitative Polymerase Chain Reaction), Spectrophotometry, and Mass Spectrometry.
Preferred qualifications
- Experience qualifying analytical instruments.
- Experience with Customer Relationship Management.
- Experience using quality systems (e.g., deviation management system, change control, corrective and preventive action [CAPA], document management system).