Senior Auditor, QA
Syneos Health
full-time
Posted on:
Location Type: Hybrid
Location: Taipei • 🇹🇼 Taiwan
Visit company websiteJob Level
Senior
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GxP quality assurance auditingaudit report writingQA Standard Operating Procedures (SOPs)Work Instructions (WIs)audit types (vendors, investigator sites, trial master files, data management, safety reporting, laboratories)regulatory requirementsmedical terminologytechnical terminology
Soft skills
organizational skillspresentation skillsinterpersonal skillscultural sensitivitynegotiation skillsproblem-solving skillsconstructive feedbackcommunication skills