Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance

Quality Assurance Associate II

Job ID
17873
Type
Regular Full-Time
Company
Seattle Cancer Care Alliance
Location
US-WA-Seattle

Overview

Seattle Cancer Care Alliance Purpose & Mission:

Seattle Cancer Care Alliance (SCCA) brings together the leading research teams and cancer specialists of Fred Hutch, Seattle Children’s, and UW Medicine. One extraordinary group whose sole mission is the pursuit of better, longer, richer lives for our patients. SCCA's purpose is to provide state-of-the-art, patient and family centered care; support the conduct of cancer clinical research and education; enhance access to improved cancer interventions; and advance the standard of cancer care regionally and beyond.


Every individual at SCCA plays a unique role in supporting our mission. Our collective success hinges on each of us conducting ourselves in accord with a set of core values:

  • We are patient-centered. Everything we do must be linked to our ability to deliver better, safer outcomes for our patients.
  • We are innovative. We nurture an environment that fosters unconventional thinking, a passion for discovery, and the open-mindedness to invite discovery from unexpected places.
  • We are respectful. We are deeply respectful of our patients, their families, and each of our colleagues who serve them in so many different and important ways.
  • We are collaborative. We understand that asking for and offering help in how to do better is not just a right, but among our most important responsibilities.
  • We are agile. We cannot just be comfortable with change; we must embrace it as proof that we are making progress.
  • We are responsible: Because our work is focused on people's well-being, we approach it with the highest level of ethical, fiduciary, and environmental responsibility.

Employees must adhere to all SCCA policies and processes, including the SCCA Code of Conduct and all HIPAA privacy requirements.

 

The Cellular Therapeutics group is responsible for all therapeutic cellular collection and processing at the Seattle Cancer Care Alliance (SCCA).  All products manufactured by the Apheresis Unit or Cellular Therapy Laboratory must meet or exceed required Food and Drug Administration (FDA) regulations, as well as compliance with the Foundation for the Accreditation of Cellular Therapy (FACT) standards, and other applicable governing agency regulations.

 

The Quality Assurance Associate II is responsible for developing and monitoring quality systems that support cellular collection, processing, distribution, and infusion for the Cellular Therapeutics Apheresis Unit and Cellular Therapy Laboratory.  A person in this position applies defined practices and policies and exercises data-driven judgment when evaluating and obtaining solutions to a diverse scope of problems. A person in this position is expected to independently perform routine work and apply working knowledge of regulations, defined procedures, and general instruction on new assignments.

 

Shift Schedule: M-F 10:00 AM - 6:30 PM

 

Responsibilities

  • Review product processing records to ensure compliance with standard operating procedures and release criteria. This includes performing read offs with Operational staff and resolving issues during the release process
  • Learn and be able to perform all Document Control responsibilities and act as back-up to the Document Control Specialist as needed.
  • Review, evaluate and investigate deviations. Work with Operational management to properly close variances. Coordinate corrective actions with Operational staff.
  • Work with Operational management or QA Specialists to train staff on Quality systems.
  • Author, revise, review and qualify standard operating procedures (SOPs) as needed.
  • Perform in-process improvement projects as a Quality Subject Matter Expert. Able to recommend changes to controlled documents as necessary.
  • Contributes to the development and implementation of Quality systems in compliance with relevant standards and regulations.
  • Work with the Quality Specialists to identify and develop Quality indicators based on improvement efforts and Quality led projects.
  • Familiarity with CTP Quality Systems (e.g. deviation management system, vendor qualification, change control, audits, metrics etc.).
  • Perform other duties as assigned.

Qualifications

  • B.S. degree with a major in biological science, medical technology or related discipline.
  • 2+ years of cellular or biological manufacturing experience including quality assurance responsibilities.
  • Working knowledge of cGMP/cGTP regulations is required.
  • Working knowledge of FACT standards is preferred.
  • Detail oriented with ability to communicate ideas effectively both verbally and in writing.
  • Able to interact constructively with peers, management and external contacts.
  • Ability to work evenings occasionally.

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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