Overview

QA Compliance Specialist Location: San Jose, CA Duties:

  • This role requires extensive experience in a GMP Operations or GMP Compliance in the Biotec, Pharmaceutical or Medical Devices Industries.
  • Manage the complaints and deviation system:
  • Perform QA assessment of deviations and ensure that all assessments are timely completed.
  • Review and approval of deviation reports.
  • Ensure that all complaints and deviations are properly and timely handled and investigated.
  • Work with the investigators and the area managers to ensure that investigations are timely submitted and approved.
  • Drive continuous improvement efforts and ensure that the deviation process flow is effectively implemented across the board. Manage the CAPA system
  • Ensure that all CAPAs are timely, initiated and assessed.
  • Drive CAPA board meetings.
  • Track CAPAs to completion and ensure that CAPAs are effectively implemented.
  • Review and approval of CAPAs.
  • Drive continuous improvement efforts and implement CAPAs related to compliance enhancement.
  • Manage the Change Control System to and ensure that all CCRs are timely and effectively implemented.
  • Responsible to periodically collect and report quality KPIs Key Performance Indicators to management.
  • Facilitate Management Review meetings and ensure that management review decisions are tracked and closed.
  • Perform self-inspections.
  • Participate in clients/ Health Authorities audits and provide back/ front room support during inspections.
  • Support the supplier quality management system quality agreements, supplier evaluation processes, material qualification.
  • Support Material Management related to deviations.

Why Kelly ® ?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly ®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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