Job Details

  • Title: Quality System Specialist
  • Code: RCI-08412
  • Location: La Verne California (CA) 91750
  • Posted Date: 05/27/2020
  • Duration: 6 Months
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  Job Description

Wed-Sat, Swing Shift 1pm - 12am, 4 x 10 Schedule

  • Conducts a comprehensive and critical evaluation of Laboratory records including but not limited to content, results, data accuracy and scientific relevance, format and adherence to GMP
  • Performs a thorough review of raw data and documentation to ensure compliance to applicable specifications and protocols
  • Supports the laboratory testing group instrument qualification and method validation review
  • Performs procedural and method revisions, where necessary
  • Conducts GMP review of laboratory notebooks, logbooks and associated forms including electronic raw data to ensure compliance with Client’s data integrity policy
  • Supports OOS/OOT investigation and CAPA implementation
  • Conducts off hour (early morning/late night/weekends) data review to support production needs
  • Provides new hire training
Specific Required Skills
  • Advanced knowledge of current Good Manufacturing Practices (GMPs), pharmacopeia and compendial requirements, and pharmaceutical industry practices
  • Strong knowledge of regulatory requirements surrounding Data Integrity
  • Familiarity of analytic testing methods and validation including laboratory instrumentation
  • Ability to apply critical thinking and good judgment
  • Strong organizational and problem solving skills
  • Strong verbal, written, and interpersonal skills are required
  • Proficiency in Microsoft Office and laboratory computerized systems such as Empowerand LIMS