We develop and manufacture fully functioning human cells in industrial quantities to precise specifications. Our proprietary iCell Operating System (iCell O/S) includes true human cells in multiple cell types (iCell products), human induced pluripotent stem cells (iPSCs) and custom iPSCs and iCell products (MyCell products).

Our iCell O/S products provide standardized, easy-to-use, cost-effective access to the human cell, the smallest fully functioning operating unit of human biology. Customers use our iCell O/S products, among other purposes, for drug discovery and screening; to test the safety and efficacy of their small molecule and biologic drug candidates; for stem cell banking; and in researching cellular therapeutics.

Fujifilm Cellular Dynamics, Inc. is seeking a Senior Quality Assurance Specialist.  This lead QA role is responsible for assisting in the development and maintenance of the Quality Management System (QMS), supporting the production and testing of cell therapies under current Good Manufacturing Practice (cGMP) guidelines, ensuring compliance with applicable U.S. and global standards. This role supports Quality operations at CDI by authoring new SOPs, maintaining data integrity, disposition process, internal/external auditing, and providing cross functional Quality Assurance support.

Essential Job Responsibilities:

1. Author and review SOP, working with team members to draft documents to support cGMP requirements (i.e. 21CFR210, 21CFR211, 21CFR600)
2. Ensure data integrity through review of records generated by cGMP activities, verifying data accuracy and traceability. 
3. Manage and review cGMP records, close-out any associated deviation and investigations, and perform QA approval as outcome of review process.
4. Conduct internal and external audits, writing reports and ensuring findings are addressed.
5. Manage deviation, investigation, CAPA, and training systems, implementing applicable procedures.
6. Provide document control support including issuance of controlled documents/labels, document tracking, processing, and archiving. 
7. Provide support for management of document and change control and coordinate the revision, review, and approval of SOPs and other GMP documents.  
8. Create and implement an accurate and reliable system for archiving cGMP documents in paper and/or electronic format.
9. Assist in the preparation of regulatory documents including briefing documents, IND filings, and Drug/Facility Master Files.
10. Participate in audits by external clients and regulatory authorities.
11. Provide quality assurance support to organization.

Essential Job Requirements:

• Bachelor's in life science or relevant scientific discipline
• Quality professional with 5 years of hands-on experience with document control process in biopharmaceutical industry, to include applicable experience implementing 21CFR210, 21CFR211, and 21CFR600 is preferred.
• Demonstrated proficiency with electronic quality management system is a plus
• Demonstrated technical writing skills with working knowledge of MS office
• Self-motivated with the demonstrated ability to work effectively with people from multiple departments, ensure deadlines are met, and manage multiple, and changing priorities.
• Proven ability to identify quality issues and effectively and proactively resolve the issues in a diplomatic and constructive manner.

Cellular Dynamics International Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status or status as an individual with a disability. All qualified applicants will not be discriminated against on the basis of a disability.