Quality Assurance Auditor II

Home Based Role, US

The Quality Assurance (QA) Auditor II will have experience and knowledge of appropriate GxP compliance

and other applicable regulations and laws, Parexel procedures and appropriate Parexel processes, which

allows the individual to plan and conduct internal and external audits independently, or with minimal

supervision. Provide advice on regulatory compliance, with appropriate supervision.

Key Accountabilities:

Perform and Report Audits Plan, schedule, perform and report a range of GxP audits across all phases of Clinical Research including, but not limited to project related audits, system audits, supplier audits, safety/pharmacovigilance (PV) auditsConduct the audits in accordance with client requirements and Parexel/client procedures, independently or with minimal supervision. Perform and deliver high quality audits /audit reports within specified timelines / budgets, with oversight.Lead or participate in co-audits / observed audits with client representatives or other QA auditors.Travel internationally for audits as required. Travel time could be up to approx. 60%.Follow-up Audits: Collect and review responses to audit observations and follow-up / escalate inadequate or delayed responses as necessary to ensure timelines are met and responses of satisfactory quality are obtained.Support Auditor Training Assist with the training of new / less experienced auditors by performing co-audits, delivering training, and sharing knowledge and experience.Billable Audits & Client Relationships (where applicable) Ensure audits are performed to a high degree of client satisfaction and within the budgeted time.Ensure required audits are delivered in accordance with client requirements and Parexel/client procedures as applicable.Ensure that systematic issues raised during billable audits are escalated to the assigned QA Lead for the programDevelop and optimize new and existing processes to maintain and improve quality within the billable group.Maintain Records / Systems Maintain required QA tools and ensure Parexel and QA systems are regularly updated with accurate information for audits and other activities.Provide Consultancy Provide advice on regulatory compliance to clients, Parexel Operations and Parexel Quality.Support the development, maintenance, review and improvement of Parexel procedures, systems and tools by providing constructive ideas and suggestions.Support Client Audits and Regulatory InspectionsFacilitate client audits / regulatory inspections, as assigned.Foster a good working relationship with internal and external clients.Maintain sound knowledge of Parexel policies, procedures, and guidelinesWorking knowledge and expertise of Parexel policies, procedures, and guidelines, as well as applicable national and international regulations and requirements; able to apply them as needed.Proactively recognize areas for process / procedural improvements, providing input to management and taking the initiative, as appropriate.Review Parexel SOPs as assigned to ensure GxP complianceBuild and maintain relationships Build, develop, and maintain good working relationships with internal and external customer groups.Work well in team environment.Perform other quality related task or projects as assignedPerform other quality related tasks as assigned.QualificationsSkillsMinimum 1 year of GCP auditing experience of Early Phase and Late Phase clinical trials in the CRO and/ or Pharma industries requiredExperience at conducting: GCP Late Phase Investigator Site AuditsTrial Master File AuditsSupplier AuditsSystem/ Process AuditsGood knowledge of international regulatory requirements and industry guidelines governing global GCP (ICH, EMA, FDA, MHRA, PMDA) requiredKnowledge and experience of other GxPs (GLP, GMP, PV, GDP, GPP, etc.) preferredEducation

BS/ BA degree or equivalent experienceEEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.