Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our people work together as one team to support our business and shorten the distance from lab to life.
Responsibilities
Plans and conducts assigned audits.
Writes and issues audit reports, ensuring clear communication of audit findings to auditees and relevant management.
Reviews responses to audit findings for appropriateness and completeness.
Closes assigned audits. Supports customer audits/inspections when required.
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.
Acts as a trainer and mentor to less experienced QA auditors.
Requires minimal instructions on day-to-day work and new assignments. Performs other tasks as assigned.
May write, review or revise QA Standard Operating Procedures (SOPs) / Work Instructions (WIs).
Moderate travel may be required (up to 50%).
Qualifications
Requires a Bachelor’s degree in the science/health care field or equivalent with extensive experience in GxP quality assurance auditing.
Experience in 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 a dynamic environment.
Strong organizational, presentation and interpersonal skills.
Cultural sensitivity for effective communication with stakeholders from diverse backgrounds.
Ability to negotiate, problem solve and provide constructive feedback.
Well-developed communication skills and the ability to write concise, accurate reports and documentation.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 studies across 73,000 sites and 675,000+ trial patients.
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks at its discretion. Equivalent experience, skills, and/or education will be considered. The Company will determine what constitutes an equivalent qualification. Nothing herein should be construed as a contract. The Company complies with applicable laws and provides reasonable accommodations where appropriate.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
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