Job Description

6+ MONTH CONTRACT

LOCATION IS SAN JOSE, CA

This is for day shift. I’m highlighting below the key responsibilities for that role:

• This role requires extensive experience in a GMP Operations or GMP Compliance in the Biotec, Pharmaceutical or Medical Devices Industries.
• This position supports the implementation of the quality systems in compliance with cGMPs and other company policies.
• Manage the deviation system:
  • Perform QA assessment of deviations and ensure that all assessments are timely completed.
  • Review and approval of deviation reports.
  • Work with the investigators and the area managers to ensure that investigations are timely submitted and approved.
  • Ensure appropriate corrective actions are assigned and closed.
  • Prepare and present metrics to senior management on a regular basis.
  • 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 review 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.
• 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.
• Reviews quality systems to identify gaps and improve quality systems to support clinical and commercial manufacturing of cell therapy products
• Support the supplier quality management system – quality agreements, supplier evaluation processes, material qualification.
• Provides training and guidance on quality agreements

Equal Opportunity Employer/Veterans/Disabled To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/ The Company will consider qualified applicants with arrest and conviction records.

Company Description

For more than a half century, ENTEGEE has been assisting engineering and technical professionals advance their careers. A proud subsidiary of The Adecco Group, the world’s largest staffing firm, our long-standing relationships and unique understanding of engineering departments and high-tech organizations allows you access to outstanding opportunities that fit your skills and your goals. We have built a reputation of honesty, quality and responsiveness by supporting our candidates with expert advice and resources. Equal Opportunity Employer