Quality Assurance Associate III

Job ID
18984
Type
Regular Full-Time
Company
Fred Hutchinson Cancer Research Center
Location
US-WA-Seattle
Category
Quality

Overview

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 Fred Hutch Therapeutics Products Program (TPP) encompasses two, distinct, clinical manufacturing facilities in support of Phase I/II clinical trials. Trials consist of both internal, faculty-driven protocols as well as external partnerships with peer institutions and industry partners.

 

The Quality Assurance Associate III is responsible for creating, developing, monitoring, and managing quality systems that support receipt, processing, testing and release for products manufactured by Therapeutic Products Program (TPP). A person in this position works on complex problems requiring data analysis and the ability to perform an in-depth evaluation of regulations and policies in selecting methods and techniques for obtaining results. Tasks are typically carried out with no instruction on routine work and may provide guidance to other junior personnel. The Quality Assurance Associate III has additional responsibilities in leading project efforts and management of quality systems.

Responsibilities

  • Support the GMP cell therapy and biologics manufacturing operations as the responsible person for Quality systems
  • Oversee self-auditing program to assure continual compliance with FACT standards and clinical regulatory requirements
  • Ensure that the change management process related to manufacturing and analytical methods are evaluated and implemented to meet GMP and internal standards
  • Manage the supplier/vendor qualification process in support of GMP activities
  • Manage the Deviation/CAPA process to insure issues are identified and appropriate corrective and preventative measures have been designed and completed in a timely manner
  • Provide QA support for validations including reviewing protocols and reports
  • Provide support in review of specification and test methods
  • Oversee routine quality management review and KPI assessments
  • Oversee compliance to the training program requirements

Qualifications

  • Bachelor of Science degree required in a scientific discipline including pharmaceutical, biologics, or related field
  • At least 5 years of cellular or biological manufacturing experience including quality assurance responsibilities or an equal combination of education and working experience
  • Working knowledge of cGMP regulation
  • Detail oriented team player with effective organization and execution skills
  • Strong communication and writing skills with demonstrated ability to work as an individual contributor and in a dynamic team environment
  • Must have the ability to stand for long periods

 

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and anti-racism in your career or that will be made through your 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.

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