GMP Materials Specialist
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 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.
At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.
The primary responsibility of a GMP Materials Specialist in the Cell Processing Facility (CPF) is to maintain and execute materials control and product logistics within the cGMP environment. The Specialist supports the control and movement of raw materials and finished goods for manufacturing. The CPF is a clinical Phase I/II manufacturing facility within the Fred Hutch, which produces products for patients participating in clinical protocols using cellular therapy.
Responsibilities
- Follow and maintain the workflows of manufacturing Materials Control such as receipt and inspection, identification, quarantine, release, storage, and issuance of GMP materials used in production
- Administrate final product shipping/distribution to our customers
- Support monitoring of inventory, ordering and handling of supplies needed for operations
- Follow Standard Operating Procedures (SOPs) and complete required processing documentation such as on logbooks
- Perform timely and accurate transactions in the business inventory control systems
- Maintain the storage areas in an organized and sanitary environment. Ensure material location status and quantity are accurate.
- Conduct cycle counts, resolve inventory discrepancy issues
- Identify issues, work collaboratively with the team to problem solve
- Identify deviations from approved policies and procedures. Document deviation, assist in the investigations, and assist in the development of CAPA.
- Evaluate current practices and operations and contribute to changes to improve performance
- Lead by example and take responsibility in the support of safety and cGMP compliance
- Report materials status/readiness to cross-functional project teams
Qualifications
Required:
- Bachelor’s degree or three or more years of experience in materials management or inventory control in a cGMP environment
- Basic computer literacy and proficiency with standard computer programs (MS Office)
- Must be able to work efficiently, with strong attention to detail in a highly regulated environment
- Must be able to support teamwork and communicate effectively in a diverse team environment
- Set an example in support of teamwork within the manufacturing group
- Must demonstrate solid time management and organizational skills, and strong verbal and written communication
- Must be able to wear clean room attire, surgical masks, and all required Personal Protective Equipment (PPE)
- Meets physical requirements of the job, as follows: can lift a minimum of 40 pounds with or without assistance of tandem lift or other materials handling equipment, and the ability to bend, reach, stretch, and climb ladders
- Ability to work the occasional weekend days or evenings
Preferred:
- Experience writing or revising standard operating procedures, Materials Specifications, and other GMP Systems documentation
- Knowledge of lean manufacturing methodologies, such as Kanban
- Knowledge of 5S for warehousing organization
A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and anti-racism in your career or that will be made through work at Fred Hutch is requested of all finalists.
Our Commitment to Diversity
We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at hrops@fredhutch.org or by calling 206-667-4700.