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  • Category: Healthcare
  • Education: Bachelors Degree
  • Employment Length: fulltime
  • Location: Seattle WA
  • Source: Business
  • Ad #: 15222
Via: kellyjobsmnetwork Apply / More Info
Full Details

Kelly Scientific is currently hiring a Quality Assurance (QA) Associate III to work on contract at a growing biotech company located in Seattle, WA. QA Associates are primarily focused on assisting in oversite of all Quality Systems, with a focus on Document Control & Records Management, Deviation/Investigation Management and Corrective and Preventive Actions (CAPA) and Change Management) as well as assist in oversite of the compliance program (internal/external audits, inspection management). This is a full-time opportunity offering competetive compensation, and working M-F 8-5 on a 1 yr contract.

Primary Responsibilities

  • Support in Management of Deviations, Change Controls, CAPA and Document Control, as they relate to activities
  • Responsible for oversight of the compliance program; including oversight of GMP and GTP vendors and service providers.
  • Assist administration for the Quality Management Systems in place
  • Assist in workflow processes of all Quality Management Systems
  • Other tasks, as they arise

Required Qualifications

  • 2+ years of experience in a Quality function in a GxP (GLP, GMP or GCP) regulated environment
  • Experience working with Electronic and Manual quality systems
  • Bachelor’s Degree, preferably with a scientific background
  • Ability to work with cross-functional teams
  • Demonstrated excellence in written and verbal communication
  • Demonstrated organization skills
  • Able to communicate well at all levels in the organization
  • Willing to think creatively about ways in which we can ensure better systems compliance and

Preferred Qualifications

  • Background in Protein Biologics or Cell Therapy Manufacturing
  • Experience implementing quality systems
  • Experience in continuous improvement, operational excellence and six-sigma
  • Experience in a GxP (GLP, GMP or GCP) regulated environment
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