Quality Systems Support Associate

San Rafael, California | Contract

Post Date: 12/07/2017 Job ID: 3648

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.

 

Skills:    

  • Excellent with writing and reviewing skills.
  • Knowledge of discrepancy records (deviations, laboratory investigation reports, out of specification, out of trend) for assignable root cause, development of appropriate CAPAs, and evaluation of CAPA effectiveness a plus.
  • Knowledge of Learning Management Systems and other QC information systems (such as Trackwise, ComplianceWire, document control systems).
  • Experience with compendial updates and compliance.
  • Meticulous record keeping skills, excellent attention to detail.
  • Knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies a plus.

Education:          

Associates degree or higher

Minimum 5 years experience with GxP environment

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