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.
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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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