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Quality Systems Specialist

Seattle, WA, USA Req #454
Thursday, July 11, 2019
Formerly Puget Sound Blood Center and Lane Blood Center, Bloodworks is backed by more than 70 years of Northwest history and 250,000 donors. A national leader in transfusion medicine, Bloodworks has been chosen to serve more than 90 hospitals in Washington, Oregon and Alaska – partnering closely with local hospitals to deliver the highest level of patient care. Patients with traumatic injuries, undergoing surgeries or organ transplantation, or receiving treatment for cancer and blood disorders all depend on our services, expertise, laboratories and research. We are local, nonprofit, independent, volunteer-supported and community-based.
We have an excellent opportunity for an experienced Quality Systems Specialist within the Quality Assurance/ Regulatory Affairs department. The incumbent would be responsible for managing and monitoring quality systems within Bloodworks, including maintaining a current working knowledge of applicable regulations and standards, reviewing and approving standard operating procedures, reviewing and approving validation plans and validations, coordinating systems audits and audit follow-up, facilitating external inspections, monitoring errors and customer service issues, and conducting quality systems training for staff.

Requirements for this position include:
 

EDUCATION & EXPERIENCE:

         Bachelor's Degree in a related field, or equivalent education and experience.

         Minimum 2 years of Quality Assurance experience in regulated environment.


JOB SPECIFIC SKILLS:

         Knowledge of current Good Manufacturing Practices for Biologics, Drugs, and Devices, also CLIA, WMTS, OSHA/WISHA, and other applicable regulations.

         Familiarity with audit principles and sampling techniques desirable.

         Demonstrated interpersonal skills in problem resolution in a team environment.

         Demonstrated ability to communicate effectively with personnel from diverse technical backgrounds.

         Demonstrated technical writing skills.

         Demonstrated negotiation and project management skills.

         Demonstrated initiative and decision making skills and ability to perform independently without direct supervision.

         Computer literacy, including proficiency with word processing, spreadsheet applications, and PC database management.


WORKING CONDITIONS:

         This position will require periodic travel to our satellite facility locations.

         This position has indirect exposure to blood borne pathogens.

This is a full-time, salaried, non-exempt position based at our Central location in Seattle's First Hill Neighborhood, with frequent travel to our Renton site. Salary is DOE, DOQ.

 
Bloodworks Northwest is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age, protected veteran status, disability status, or any other characteristic protected by law. 

Other details

  • Job Family 2.1 - General & Admin Professionals
  • Job Function LTD Class - Executive, Manager, Professional
  • Pay Type Salary
  • Employment Indicator Regular
  • Travel Required Yes
  • Travel % 25
  • Required Education Bachelor’s Degree
  • Seattle, WA, USA