Auditor ll , Quality Assurance

Job Summary

Conduct audits to assess compliance with applicable regulations, company policies, standard operating procedures (SOPs) and work instructions (WIs), contracts and project-specific requirements. Hosts and supports customer audits and regulatory inspections in accordance with QA SOPs and WIs.

JOB RESPONSIBILITIES

General Profile

Syneos Health Audits

• Plans and conducts assigned audits.
• Writes and issues audit reports, ensuring clear communication of audit findings to the auditees and relevant management.
• Reviews responses to audit findings for appropriateness and completeness.
• Closes assigned audits.

Customer Audits/Inspections

• Prepares for and hosts or supports customer audits.
• Assists senior QA personnel in hosting or supporting Regulatory Authority Inspections.

Supervision

• Requires some instructions on day-to-day work and new assignments.

Other tasks

• Performs other work-related duties as assigned.
• Moderate travel may be required (up to 50%).

QUALIFICATION REQUIREMENTS

• Requires a Bachelors degree in the science/health care field or equivalent with moderate experience in GxP quality assurance auditing.
• Good knowledge of GxP regulatory requirements.
• Knowledge of Medical and technical terminology related to the audit types to be conducted .
• Computer literacy commensurate with job requirements (Microsoft Office suite; basic Sharepoint proficiency).
• Able to handle multiple tasks to meet timelines in a dynamic environment.
• Strong organizational, presentation and interpersonal skills.
• Cultural sensitivity to allow effective communication with stakeholders from diverse cultural backgrounds.
• Ability to negotiate and provide constructive feedback.
• Well-developed communication skills and the ability to write concise, accurate reports and other necessary documentation.

Link to apply: https://wd12.myworkday.com/syneoshealth/d/inst/1$14180/5303$4157.htmld#TABTASKID=2998%2417247