Accounting/Auditing, Manufacturing and Production, Science, Research & Development, Nonprofit and Volunteer Services, Energy / Utilities
Document Control Associate II
Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first and largest cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
The Cellular Processing Facility is responsible for manufacturing modified cell products that are given to patients who participate in Fred Hutchinson Cancer Research Center clinical trials. The Document Control Associate performs daily document management operations while maintaining compliance with GMP regulations.
Under the direction of the Document Control Specialist, the Document Control Associate will be responsible for supporting GMP operations of the Cell Processing and Biologics Production Facilities. Quality Document Control electronic document management system, as well as acting in a Subject Matter Expert role to ensure timely document processing throughout the site while maintaining compliance with GMP regulations. The Document Control Associate oversees the Records Management function at the site, ensuring that GMP records are processed and archived according to established procedures and in compliance with corporate retention policies.
The position requires coordinating the needs of multiple functional areas for document processing and records submission/retrieval.
Prepare and issue GMP manufacturing batch records.
Issue and reconcile GMP logbooks.
Perform scanning of GMP documentation.
Provide document retrieval support during internal and external client audits.
Organize and archive GMP documentation.
Process document change requests for new documents and revisions.
BA/BS degree or 2+ years document control or equivalent work experience in a regulated environment (GMP, GLP).
Strong organization, attention to detail, problem-solving, and time management skills required.
Strong communication and interpersonal skills required.
Thorough understanding of Microsoft Office Suite (Word, Excel, and Visio), Sharepoint, and Adobe Acrobat required.
Must be able to work well within a team environment and function with little supervision.
Must be able to lift and move 40 pounds.
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