Senior Quality Assurance Auditor (Raleigh, NC)
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POST DATE 8/17/2016
END DATE 10/28/2016
Conducts audits of on-going Company projects, and assist with other QA program initiatives. Provides guidance to less experience staff.
* Schedules, conducts, and documents assigned audits of the Company s projects and operational processes in accordance with approved procedures, schedules, and formats. Specific audit areas will include, but are not limited to:
* Investigator Sites
* Trial Master and Project Management Files
* Project Databases (and their development)
* Data Management Activities and File
* Safety Reporting
* Final Study Reports
* Staff Training Records
* Hosts Sponsor audits and assists senior QA personnel in Regulatory Authority inspections per Company s policies and procedures.
* Writes and issues audit reports in accordance with standard Company formats and timelines, ensuring clear communication of audit findings to the relevant project team members and/or functional area management.
* Reviews responses to audit findings for appropriateness and completeness. Follow up as appropriate to obtain audit response.
* Maintains accurate and timely documentation of QA auditing activities.
* Serves as a trainer and mentor to less experienced QA Auditors.
* Serves as Lead Auditor on team-based audits and/or for project audits.
* Manages assigned quality issues in accordance with Company requirements.
* Provides consultancy on quality and regulatory related issues for QA functions.
* Provides training on quality/regulatory area to Operations departments.
* Writes, reviews or revises QA Standard Operating Procedures (SOPs) / Work Instructions (WIs).
* Performs other work-related duties as assigned. Extensive travel may be required (up to 75%).
BA/BS degree in the science/health care field or equivalent combined education and experience. Extensive experience in clinical quality assurance auditing and conduct of vendor audits (e.g. of central laboratories, clinical suppliers, IRBs, etc.). Strong knowledge of all applicable Good Clinical Practice regulations and guidelines. Knowledge of medical terminology preferred. Well-developed communication skills and the ability to write and present concise, accurate reports and other necessary documentation. Ability to handle multiple tasks to meet deadlines in a dynamic environment. Strong organizational, presentation, documentation, and interpersonal skills with diverse cultures. Ability to negotiate and provide constructive feedback. Must be able to work as part of a team as well as independently. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail.
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.