Description
Syneos Health is seeking an Auditor II, QA with GCP experience to join their team.
Job Summary As an Auditor II, QA, you will conduct audits to assess compliance with applicable regulations, company policies, standard operating procedures (SOPs) and work instructions (WIs), contracts and project-specific requirements. You will also host and support customer audits and regulatory inspections in accordance with QA SOPs and WIs.
Responsibilities
- Plan and conduct assigned audits
- Write and issue audit reports, ensuring clear communication of audit findings to the auditees and relevant management
- Review responses to audit findings for appropriateness and completeness
- Close assigned audits
- Prepare for and host or support customer audits
- Assist senior QA personnel in hosting or supporting Regulatory Authority Inspections
- Perform other work-related duties as assigned
Requirements
- Bachelor's degree in a science/health care field or equivalent with moderate experience in GCP quality assurance auditing
- Good knowledge of GCP 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)
- Ability 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
Benefits Syneos Health offers a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition and total rewards program.