Job Description

Home Based, 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. Stong background in GCP auditing strongly preferred.

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) audits
• Conduct 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. 50 - 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 program
• Develop and optimize new and existing processes to maintain and improve quality within the billable group.

Support Client Audits and Regulatory Inspections

• Facilitate client audits / regulatory inspections, as assigned.
• Foster a good working relationship with internal and external clients.

Maintain sound knowledge of Parexel policies, procedures, and guidelines

• Working 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 compliance

Build and maintain relationships

• Build, develop, and maintain good working relationships with internal and external customer groups.
• Work well in team environment.

Education

• Educated to the degree level (biological science, pharma, quality assurance or other related discipline preferred) or relevant clinical or business equivalent

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