JOB SUMMARY Conduct audits to assess compliance with applicable regulations, company policies, standard operating procedures and (SOPs) work instructions (WI), contracts and project-specific requirements. Hosts and supports customer audits and regulatory inspections in accordance with QA SOPs and WIs. Provides guidance to less experienced QA auditors.
JOB RESPONSIBILITIES Syneos Health Audits • 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. Customer Audits/Inspections • Prepares for and hosts or supports customer audits. • Prepares for and hosts or supports Regulatory Authority Inspections. Other • Serves as Lead Auditor on team-based Syneos Health audits. • Serves as a trainer and mentor to less experienced QA auditors.
Supervision • Requires minimal instructions on day-to-day work and new assignments.
Other tasks • 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%).
Disclaimer: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Requires a Bachelor’s degree in the science/health care field or equivalent with extensive experience in GCP 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 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). • 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
Position is located in Morrisville, NC. Alternatively, the applicant may be remote based and travel to Morrisville 1-2 times per month.
Internal Number: 19009651
About Syneos Health
Why Syneos Health?
Join a game-changing company that is reinventing the way therapies are developed and commercialized. We bring together more than 24,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.