Quality Assurance Associate II

Company: Fred Hutchinson Cancer Research Center
Location: Seattle
Posted on: March 20, 2023

Job Description:

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. - - -
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 II/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

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• Supports the cGMP cell therapy and biologics manufacturing operations as the responsible person for Quality systems
  
• Performs the batch record reviews, product release and associated deviation records. - Perform the review and investigation on the deviation records to meet the quality compliance requirements.
  
• Provide Quality Assurance oversight throughout the end-to-end production operations assuring current GMP compliance requirements
  
• Supports self-auditing program to assure continual compliance with FACT standards and clinical regulatory requirements
  
• Ensures that the change management related to manufacturing methods are evaluated and implemented to meet GMP requirements and internal standards
  
• Review and approve procedures, master batch records, and other QA controlled documentation, and associated document change requests.
  
• Partner with functional areas to resolve product quality impacting investigations and own CAPA related to area of responsibility.
  
• Manage the Deviation/CAPA process to ensure 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
  
• Participate and support internal and external audits
  
• Provide support in review of specification and test methods
  
• Embody lean principles and methods while fostering a continuous improvement mindset
  
  Qualifications
  Minimum Qualifications for QA Associate II:
  
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  • Bachelor of Science degree required in a scientific discipline including pharmaceutical, biologics, or related field
    
  • 3-5 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
    
  • Must be able to wear appropriate clean room attire and have the ability to wear all required Personal Protective Equipment (PPE)
    
    Minimum Qualifications for QA Associate III:
    
    • 
      
    • Bachelor of Science degree required in a scientific discipline including pharmaceutical, biologics, or related field
      
    • 5-8 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
      
    • Must be able to wear appropriate clean room attire and have the ability to wear all required Personal Protective Equipment (PPE)
      
      Fred Hutchinson Cancer Center has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations. As a condition of employment, newly hired employees must, prior to their first day of employment: Provide proof of being fully vaccinated against COVID-19 ; ORInitiate the accommodations process to request a religious or medical accommodation (medical accommodations require a healthcare provider's certification). A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.
      The annual base salary range for this position is from $89,979 to $122,969, and pay offered will be based on experience and qualifications. - -Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months). -
      Our Commitment to DiversityWe 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.

Keywords: Fred Hutchinson Cancer Research Center, Seattle , Quality Assurance Associate II, Other , Seattle, Washington