GMP Materials Specialist | GenomeWeb

GMP Materials Specialist

Organization
Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance
Job Location
Seattle, WA
Job Description

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.
This position, reporting to the Manufacturing Manager, is responsible for the physical and administrative tasks involved in the receipt, labeling, storing and distribution of GMP and non-GMP materials. Addition responsibilities will include the unpacking and verification of materials against purchase orders or invoices, the maintenance of records for received materials and the rejection of unsatisfactory items as necessary.

- Support monitoring, ordering, receipt, inspection, and labeling of raw materials and supplies used in GMP manufacturing operations.
- Improve and maintain inventory control procedures and documentation for all raw materials and supplies.
- Work with key stakeholders to implement a new electronic inventory management system.
- Create and maintain material specifications for new and existing raw materials and supplies.
- Work with raw material suppliers to resolve material supply and quality-related issues.
- Maintain and organize cGMP material storage areas.
- Create a system for "kitting" raw materials used in GMP manufacturing.
- Limited exposure to 2-8°C, -20°C, -80°C, and Liquid Nitrogen (-135°C) storage equipment/areas.
- Requires minimal handling of human cells, tissues, and cellular and tissue-based products to support operations.
- May supervisor material staff as required.

- Bachelor's degree or higher.
- 3+ years of GMP experience required in warehouse operations, material handling, inventory control, etc. 5+ years preferred.
- Knowledge of handling temperature-sensitive products including receiving, storage, labeling and packaging.
- Ability to read, write, and interpret technical information and specifications in English.
- Self-motivated and detail-oriented with absolute adherence to all related procedures.

Meets physical requirements of the job, as follows: must have the ability to lift a minimum of 50 pounds, the ability to bend, reach, stretch, climb ladders and work in tight spaces in order to complete job tasks.

- Basic mathematical and organizational skills, good written and verbal communication skills and basic problem solving skills.
- Has a thorough understanding of cGMP requirements for clinical manufacturing.
- Basic computer proficiency working with MS office and database software.
- Ability to follow guidelines of the Standard Operating Procedures (SOPs) for each operation in the process to conform to the Good Manufacturing Practice (GMP) and the Food and Drug Administration (FDA) Regulations
- Basic computer proficiency working with MS office and database software.

We are a VEVRAA Federal Contractor

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