Hybrid Senior Auditor, QA

at Syneos Health

• Job title: Senior Auditor, QA
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Taipei, Taiwan

About the role

• QA Auditor conducting various quality assurance audits at Syneos Health. Preparing for regulatory authority inspections and mentoring less experienced QA auditors.

Responsibilities

• Plans and conducts assigned audits
• Performs For Cause 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
• Prepares for and hosts or supports customer audits
• Prepares for and hosts or supports Regulatory Authority Inspections
• Serves as Lead Auditor on team-based Syneos Health audits
• Serves as a trainer and mentor to less experienced QA auditors
• May write, review or revise QA Standard Operating Procedures (SOPs) / Work Instructions (WIs)
• Performs other work-related duties as assigned
• Moderate travel may be required (up to 50%)

Requirements

• Requires a Bachelor’s degree in the science/health care field or equivalent with extensive experience in GxP quality assurance auditing
• Previous experience in the conduct of multiple audit types (e.g. vendors, investigator sites, trial master files, data management, safety reporting and laboratories) is preferred
• Excellent 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 dynamic environment
• Strong organizational, presentation and interpersonal skills
• Cultural sensitivity to allow effective communication with stakeholders from diverse cultural backgrounds
• Ability to negotiate, problem solve and provide constructive feedback
• Well-developed communication skills and the ability to write concise, accurate reports and other necessary documentation

Benefits

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition
• Total rewards program