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Quality Assurance Auditor - GLP

The Quality Assurance Auditor is responsible for ensuring that all company business confirms to applicable Good Laboratory Practice regulations (including GLP, OECD, EPA and MHLW) and ensure each applicable Standard Operating Procedure is followed. May also be requested to help write, develop, and establish procedures per company's request. 

Key Responsibilities

  • Audit protocols, data, reports,and conduct experimental phase audits to ensure compliance with applicable regulations and SOPs
  • Effectively communicate audit findings to Study Directors and Management as necessary
  • Prepare QA Statements as appropriate
  • Review Standard Operating Procedures 
  • Assist in maintaining training files
  • Attend meetings as requested
  • Other duties as assigned

Qualifications and Experience

  • Bachelor's Degree (B.S. or B.A.) in biology, chemistry, or related discipline from a four-year college or university. 
  • 2+ years experience in a technical QA role, preference given for analytical experience
  • Ability to read, analyze, and interpret common scientific and technical journals, etc. Must have exceptional written and verbal communication skills. 
  • Ability to apply advanced mathematical concepts and formulas to certain procedures. 
  • Ability to use independent thinking to make judgment calls as necessary in situations open to interpretation. Must be thorough, detail-oriented and precise. 
  • Proficient in typing and good knowledge of software programs such as Microsoft Word, Excel, PowerPoint, etc. Ability to learn new software applications as needed. Preference for experience with win on lin software. 

 

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