Kelly Services Quality Auditor (GCP) in Boston, Massachusetts
Auditor Quality and Compliance
Hybrid Remote and Onsite
PURPOSE/SCOPE: The auditor is responsible for conducting clinical study audits of investigator sites and third party organizations (TPOs) and internal departments, writing reports and maintaining audit records. Working with the QMC team, participates in the assessment and development of Corrective and Preventative Action (CAPA).
ROLE AND RESPONSIBILITIES
Manage internal Quality Audits, CAPA, Quality Management Reviews, and Quality Audit, in conjunction with the Director of Quality Management & Compliance and the QMC team
Develop the investigator sites and TPO site audit schedule, including identification of TPOs and sites to be audited in a yearly basis to be approved by the QMC Director and QMC Manager
Lead qualification, routine and for-cause audits of TPOs and investigator sites to assess effectiveness of quality management systems (QMSs), compliance to approved clinical study protocols and applicable regulations
Ensure timely issuance of audit reports, audit observation forms, oversee audit response process and drive audits to closure
Maintain and enhance procedures for communicating audit observations and tracking audit responses
Contribute to quality and compliance process improvements
Develops metrics and indicators to identify audit trends and improve key quality determinants of all aspects of GCP operations
Approximately 50% travel is required to conduct investigator site and TPO audits.
Perform other related duties as assigned
QUALIFICATIONS AND EDUCATION REQUIREMENTS
Bachelor of Science or Bachelor of Arts degree required, preferably in a relevant scientific discipline
At least 3-5 Years GCP QA auditing/monitoring experience
ASQ, Auditor, CCRP, or ACRP accreditation preferred Candidates must demonstrate the following competencies:
Manage interpersonal relationships by interacting and communicating with clarity, tactfulness and courtesy with internal and external personnel
Communicate effectively, both orally and in writing
Organizational and prioritization skills
Work effectively as a part of a team and independently with minimal supervision
Ability to work under pressure and coordinate multiple tasks
Attention to detail
Time management, multi-tasking, problem solving, and effective communication skills
Proficient in MS Office suite (MS Office products, Word processing, Excel spreadsheets, e-mail management and good etiquette)
Why Kelly ® ?
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.
About Kelly ®
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
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