QC Lab Coordinator - Therapeutic Products Program

Job ID
23429
Type
Regular Full-Time
Location
US-WA-Seattle
Category
Quality

Overview

The 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.  

Responsibilities

Under the supervision of the TPP Facility Director, the TPP QC Lab Coordinator is responsible for overseeing projects, associate schedules, resources, and other activities of the Quality Control Laboratory (QC Lab) of the Cell Processing and Biologic Production facilities within the Therapeutic Products Program (TPP).

 

JOB DUTIES:

  • Support the portfolio of cell and biologic products analyzed by TPP QC Labs at various steps in manufacturing (in-process, final formulation, product release/distribution). Will coordinate with TPP Manufacturing, TPP Quality Assurance, and external clients (when applicable).
  • Coordinate with QC Associates to schedule in-process and final product release tests conducted in TPP QC laboratory and affiliate testing facilities.
  • Coordinate QC Associate workloads, sampling and testing calendars.
  • Conduct routine QC Lab audits (quarterly) and facilitate as needed audits or informal inspections to ascertain that all activities conform to cGMP and accrediting agency standards.
  • Formally document audit findings and review reports with the TPP Facility Director.
  • Oversee the portfolio of deviations, investigations, and corrective/preventive action plans for CPF and BPF QC.
  • Maintain QC databases including Excel Workbooks and RedCap.
  • Perform tracking and trend analyses from QC databases for quality control metrics, audit findings, and deviations.
  • Monitor and review entry of test results into appropriate manufacturing batch records. Ensure adherence of documentation with cGMP principles.
  • Facilitate external and internal proficiency testing in collaboration with the TPP Training Coordinator to ensure QC Associates onboarding, training and competency assessments are up to date.
  • Track inventory of QC Lab equipment, reagents, and supplies. Oversee purchase of reagents/supplies, handle equipment maintenance, calibration and repairs.
  • Perform billing activities for testing services provided for internal (FHCC) and external clients.
  • Member of TPP Quality Control Unit.

Qualifications

MINIMUM QUALIFICATIONS:

  • BS degree in an appropriate scientific field.
  • Experience working in a GLP or GMP regulated setting (minimum one year).
  • Familiarity with databases and analytical software/programs (Excel, RedCap, Tableau etc.).

PREFERRED QUALIFICATIONS:

  • Familiarity with regulatory requirements for laboratory-based test methods.
  • Familiarity with GLP or cGMP cell/biologics production facilities.

Fred Hutch 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 provide proof of vaccination or initiate the accommodations process before their first day of employment.

 

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.

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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