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QA Auditor

Durham, NCRandstad LifeSciences

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Job Title:  QA Auditor

Job Summary

  • Plan, conduct, and report assigned quality assurance audits.
  • Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies.
  • Provide quality assurance oversight under the direction of senior QA staff through interaction with customers, project and study teams and associated Q2 Solutions functions. 

Position Responsibilities

  • Plan, schedule, conduct, report and close assigned audit activities in any of the countries involved with Q2 Solutions contracts to assess compliance with applicable regulations/guidelines, customer requirements, Q2 Solutions SOPs and project specific guidelines/instructions. 
  • Conduct quality assurance activities and projects for clients according to Q2 Solutions departmental or customer policies and procedures within budget and established timelines scheduling, conducting, reporting, and closing audits. 
  • Assist in preparation and review of corrective action plans. 
  • Represent quality assurance program on customer and project teams under the direction of more senior QA staff. 
  • Document and report quality and compliance issues to QA management according to required timelines. 
  • Advise quality assurance management on system audit needs. 
  • Assist in hosting customer audits, mock regulatory inspections, and regulatory facility inspections by serving as Scribe, reviewing documents and identifying and calling operational staff to answer questions as needed.
  • May host some customer audits independently as directed by QA line management. 
  • Assist in preparation and review of corrective action plans associated with customer audits 
  • Enhance and maintain a working knowledge of GCP, CAP, CLIA regulations 
  • Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time.

Education & Qualifications

  • Bachelor’s/primary degree 
  • 3 years experience in pharmaceutical, technical, or related area including GXP and/or Quality Assurance experience; or equivalent combination of education, training and experience; 
  • Experience working in a regulated laboratory environment 
  • Experience working a Laboratory Information Management Systems a plus 
  • Knowledge of Microsoft Excel, Word, and other applications. 
  • Considerable knowledge of GXP regulations esp. GCP, CLIA and quality assurance auditing techniques. 
  • Strong interpersonal skills. 
  • Effective organization, communication, and team orientation skills. 
  • Ability to initiate assigned tasks and to work independently. 
  • Ability to manage multiple projects. 
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients 


  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance


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