GMP Materials Specialist

Job ID
22654
Type
Regular Full-Time
Company
Fred Hutchinson Cancer Research Center
Location
US-WA-Seattle
Category
Manufacturing

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

 

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.  

 

This position, reporting to the GMP Materials Supervisor, is responsible for maintaining inventory in support of clinical trials for the Therapeutic Products Program. This position manages the cGMP workflow for raw materials used to produce cellular and gene therapies in support of clinical research studies.

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.
  • Support monitoring of inventory, ordering, and handling of supplies needed for operations.
  • Follow Standard Operating Procedures (SOPs) and complete required documentation such as on logbooks and forms.
  • 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.
  • Administrate final product shipping/distribution to our customers.
  • Identify issues, work collaboratively with the team to problem solve and implement changes.
  • Identify deviations from approved policies and procedures. Document deviations, 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.
  • Ensures that equipment used for raw material storage, such as fridges and freezers, are working properly and is appropriately maintained per quality standards.
  • Work with manufacturing and technical staff to create, revise, and edit materials-related SOPs and product specifications as needed.

Qualifications

  •  1-2 years of experience in Materials Control within regulated environment, such as cell therapy or biologics product, aerospace, or equivalent.
  • High School diploma or equivalent. 
  • Ability to work with limited supervision in a fast-paced, dynamic, and highly regulated environment.
  • Must have strong communications skills, both verbal and written, within a diverse team environment.
  • Basic computer skills (MS Office).
  • Must be able to wear clean room attire, surgical masks, and all required Personal Protective Equipment (PPE).
  • Shifts are 4 days/week, 10 hours/day with some occasional weekend and holiday work.
  • Meets physical requirements of the job, as follows: can lift a minimum of 25 pounds and the ability to bend, reach, stretch, and climb ladders.

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.

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