Job Type
Contract Full-Time

Job Description

BCTG’s direct Life Science’s client is looking for a QMS-Master Control Systems Analyst / Lead to lead the implementation of a new Quality Mgt. System implementation.

  • 3-8+ years’ experience in a Quality environment using with exhibited knowledge and proficiency of requirements for implementing, validating, and maintaining a QMS-MasterControl within GMP regulated field
  • Attention to detail and organization of tasks and work loads
  • Excellent communication skills in writing, listening, and responding with feedback
  • Working knowledge of applicable GxP regulations, particularly GAMP5, 21 CFR Part 11, Annex 11, PIC/s Annex 11, and current guidance on Data Integrity and computer systems
  • Proficiency in Microsoft Office (Word, Excel, PowerPoint)
  • Knowledge in all aspects of GxP regulations (e.g. quality systems, root cause analysis and Total Quality Management) preferred. Including International regulations
  • Experience in a computer systems validation or quality assurance role
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