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Senior Quality Assurance Auditor
2 months ago
About the Role
We are seeking a highly skilled Senior Quality Assurance Auditor to join our team at Syneos Health. As a Senior Quality Assurance Auditor, you will play a critical role in ensuring the quality and integrity of our operations.
Key Responsibilities
- Plan and conduct audits to ensure compliance with regulatory requirements and company policies.
- Perform For Cause audits to investigate and address any deviations or non-compliance issues.
- Write and issue audit reports to communicate findings to auditees and management.
- Review responses to audit findings to ensure appropriateness and completeness.
- Closing assigned audits.
Customer Audits/Inspections
- Prepare for and host or support customer audits.
- Prepare for and host or support Regulatory Authority Inspections.
Other Responsibilities
- Serve as Lead Auditor on team-based Syneos Health audits.
- Serve as Assisting Auditor on team-based Syneos Health audits.
- Serve as a trainer and mentor to less experienced QA auditors.
Requirements
- Requires a Bachelor's degree in the science/health care field or equivalent with 5 years experience in GxP quality assurance auditing in the Pharma or CRO sector.
- Previous experience in the conduct of multiple audit types (e.g. vendors, process, computer system validation).
- Previous experience in supporting customer audits or regulatory inspections is a plus.
- Excellent Knowledge of GxP regulatory requirements with in-depth knowledge of Computer Systems Quality.
- Knowledge of ISPE GAMP5 concepts is preferred.
- 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, problem solve and provide constructive feedback.
- Well-developed communication skills and the ability to write concise, accurate reports and other necessary documentation.
What We Offer
- A company car or car allowance.
- Health benefits to include Medical, Dental and Vision.
- Company match 401k.
- Eligibility to participate in Employee Stock Purchase Plan.
- Eligibility to earn commissions/bonus based on company and individual performance.
- Flexible paid time off (PTO) and sick time.
