Job Details

  • Title: Quality Specialist
  • Code: RCI-GILD-06603
  • Location: Foster City California (CA) 94404
  • Posted Date: 07/15/2019
  • Duration: 6 Months
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  Job Description

Quality Specialist with knowledge of drug development process and expertise in providing quality oversight for process, and supporting internal audits and regulatory inspections.

  • Conduct process reviews – assess procedural documents (PDs) like SOPs, WRKs, MANs, and other Business Enabling Documents (BEDs)
  • Conduct TMF reviews of essential documents
  • Identify risks, gaps and/or areas for process improvement and areas for improvement in existing PDs
  • Support internal audit and/or external regulatory authority inspection activities
  • Support and track CAPA activities
  • Assist in tracking of Training records
  • Assist in Vendor Oversight activities
  • Define, implement and track quality metrics
  • Collaborate with other quality and compliance functions
  • Support implementation of changes in processes andqualir PDs
Knowledge and Skills:
  • Demonstrated expertise in working in GxP Quality functions, GCP preferred
  • Knowledge of Business Analysis and experience in creating and modifying process maps
  • Demonstrated ability to create/update documents with high degree of accuracy
  • Demonstrated ability to work independently with accuracy – create draft documents, resolve comments and feedback
  • Expertise in MS Word, MS Office tools like PowerPoint, Excel, and SharePoint
  • Strong verbal, written, and interpersonal communication skills
  • Demonstrates facilitation skills and uses collaborative approach to solve problems
  • Demonstrates ability to complete high quality work on multiple concurrent projects under tight deadlines
  • Required experience working in Life Sciences and/or GxP environment
  • Prefer experience working in Clinical Operations or Biometrics
  • Prefer experience in interpreting regulatory agency guidance document