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Quality Systems Support Associate

Compass Consulting Group, San Rafael CA


Our client  focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.

Duties

  • Review and closure of QC discrepancy reports within specified timelines: EM excursions, laboratory deviations, laboratory investigation reports, out of specification/trend reports.
  • Provide technical expertise and knowledge to QC support group in determining root causes and developing effective CAPAs.
  • Reviewing compendial updates and evaluating current QC practice compliance.
  • Providing departmental metrics.
  • Assisting with the closure of departmental Change Requests.
  • Training record GDP review and resolution. 
  • Assist in the investigation of training discrepancies.
  • Support the FVIII production/project for deviations, discrepancies and training item build for QC.
  • Record entry into Learning Management Systems.
  • Assist with the development and administration of the training system for QC groups.

 

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