Senior Quality Assurance Specialist

Fujifilm•Madison, WI

About The Position

Support Quality Assurance initiatives, ensure implementation of Quality Management Systems and compliance with applicable regulations, guidelines, and quality standards. This role provides interacts with cross functional teams providing support for the manufacture of products. This role performs a range of tasks which include but are not limited investigations, document creation, metric generation and ensure compliance of the quality system. Orchestrate, track and maintain essential documentation (SOPs, manufacturing records, specifications, change controls, third party records) as they progress through, and eventually reside in, the document control system. Regularly apply Innovation, initiative, and attention to detail to identify deficiencies and improve the efficiency of information flow through this system. At FUJIFILM Cellular Dynamics, we’re unlocking the power of human cells to change lives. Using revolutionary induced pluripotent stem cell (iPSC) technology, we drive advancements in drug discovery, disease modeling, cell therapy, research tools, and cell therapy manufacturing. Our mission is deeply meaningful, and we’re looking for bold innovators to join us. At FUJIFILM Cellular Dynamics, you’ll thrive in a collaborative and cutting-edge environment that encourages creativity and celebrates breakthroughs. If you’re ready to do work that makes a real impact and propels healthcare forward, this is your chance to be part of something extraordinary for science, patients, and yourself. Our headquarters is in Madison, Wisconsin, a dynamic city celebrated for its lakes, parks, cultural richness, biotech leadership, and access to world-class academia. 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.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Requirements

Bachelor’s degree in a life science discipline such as but not limited to cell biology, biochemistry, or microbiology, or its equivalent
5 years of relevant quality assurance experience with demonstrated achievements and progressive responsibilities.
Demonstrated organizational; problem solving; decision-making; communication (oral and written); and influencing skills – dealing with diverse stakeholders
Detailed focused, with demonstrated writing and communication skills using MS Office.
Functional knowledge of cGMP principles and practices.
Functional proficiency with an electronic Quality Management System
Able to work at computer for extended

Responsibilities

Review of documents and records used to support Good Manufacturing Practice and Discovery Research Operations, approving quality assurance records as appropriate, ensuring compliance with current SOPs
Coordinate the review and revision of Documents within the eQMS system.
Assist with preparation, formatting, distribution, routing, and maintenance of SOPs and other version-controlled documents.
Create and maintain system for document storage and maintenance.
Manage the company’s training record storage system. Conduct new hire orientation training and development activities for the QMS system.
Oversee maintenance of quality system processes to ensure compliance with regulatory and business objectives.
Support or lead investigations, root cause analysis by making data driven and technical decisions, using critical thinking skills.
Write, revise, and review standard operating procedures and operational documents (eg. Manufacturing procedures and Quality Control procedures).
Provide quality assurance support to organization.
Ensure compliance with all applicable domestic and international regulatory requirements and quality system regulations and standards associated with product manufacture and release.
Generate quality metrics as needed.
Other job functions as assigned.