Careers

Sr. QC Specialist

Location

Tokyo, Japan

Mission

Your mission is to ensure the quality and reliability of the equipment and consumables that underpin our technology, strengthening the consistency and reproducibility of the entire manufacturing process. By establishing evaluation standards and test methods from the ground up and driving continuous, data-driven improvements. You will build the foundation that enables CellFiber’s technology to scale globally with trusted, world-class quality.

Key Responsibilities

＜Establish & Lead Testing Methods＞
• Develop qualification protocols for equipment used in GMP manufacturing.
• Evaluate the quality of plastic single-use products (e.g., sterilization validation, extractables/leachable, container integrity)
• Perform quality testing for reagents (e.g., sterility, endotoxin, mycoplasma, viscosity, visual inspection)
• Conduct chemical-resistance testing for surface materials.

＜Build & Standardize QC Systems＞
• Create sampling plans for incoming inspection, in-process control, and release testing.
• Develop SOPs covering test methods, measurement conditions, and documentation formats.
• Establish cross-functional QC workflows in collaboration with R&D and external manufacturing partners.
• Support root-cause analysis and corrective actions in response to quality issues.

＜Quality Data Analysis & Improvement＞
• Collect, analyze, and monitor quality data—including statistical evaluations.
• Contribute to quality reviews and propose improvements to enhance reproducibility and reliability.
• Lead small-scale quality improvement projects (e.g., defect reduction, test efficiency enhancement)

＜Quality Assurance Support＞
• Support nonconformance handling, change control, and CAPA-related processes.
• Prepare documentation and act as SME during internal and external audits.

＜Cross-Functional Collaboration & Training＞
• Identify and resolve quality issues through collaboration with internal teams.
• Assess the quality systems of external manufacturers and suppliers.
• Develop and deliver internal training related to QC processes.

Must Have

• Bachelor’s degree or higher in a science/engineering field with a physics or chemistry background
• Experience establishing QC processes or test methods
• Experience working with industry standards (JIS, ISO, ASTM, ANSI, etc.)
• Hands-on involvement in root-cause analysis and quality improvement activities
• Ability to adapt to a fast-changing startup environment and build systems proactively
• Leadership to engage stakeholders and drive improvements based on root-cause understanding
• Business-level proficiency in Japanese or English (spoken and written)

Nice to Have

• Practical experience in equipment qualification or hardware inspection for manufacturing devices.
• Experience designing or standardizing new test methods or evaluation criteria.
• Knowledge of statistical quality control (e.g., SPC) or reliability assessment.
• Experience working within ISO or GxP quality systems.
• Technical communication experience with overseas manufacturers or partners.
• Experience in startup or small-team environments.

Who You Are

• Quality
Pursue accuracy and consistency and focus on data to identify the true drivers of quality.

• Commitment
Take ownership beyond your immediate scope and persist until the job is complete.

• Challenge
Thrive in environments without established frameworks and proactively lead solutions.

• Teamwork
Collaborate across departments and levels, engaging stakeholders to achieve meaningful results together.