Quality Assurance Auditor - Work from Home / Remote

Atlantic Research Group - Raleigh, NC4.3

Full-time
Atlantic Research Group is a niche CRO specializing in orphan, rare and personalized drug development who is highly committed to our clients, boasting a 90% plus repeat customer rate. Our work culture is a balance between serious scientific problem solving and a relax environment that rewards both teamwork and individual efforts. ARG offers a competitive salary and profit sharing, a comprehensive benefit package and complete support from our managing partners.

ARG is currently looking for an full-time experienced GCP Quality Assurance Auditor preferably in the Charlottesville, VA area to join our growing team. However, the right candidate can work remote / from home. The QA Auditor is responsible for conducting various types of routine and for cause audits including: site audits, vendor, audits, internal process audits, validation audits, trial master file audits, training audits and database audits.

Essential Responsibilities
  • Conduct various routine and for cause audits including but not limited to system validation, site, trial master file, vendor and internal process audits.
  • Document audit findings within ARG’s proprietary clinical trial management system.
  • Conduct audits to ensure compliance with local and federal regulations, ICH GCP, protocol and ARG or Sponsor’s Standard Operating Procedures.
  • Facilitate and participate in project team meetings to develop appropriate resolution plans or CAPAs.
  • Serve as a regulatory reference for ARG staff.
  • Travel as necessary for conducting audits.
Qualifications:
Education­
  • BA, BS or MS in bio­scientific, health care or life sciences
Experience ­
  • Previous GCP auditing experience required
  • Experience as an on­site clinical monitor is a plus
Skills
  • Superior clinical auditing and monitoring skills
  • Excellent decision making skills and sound judgment
  • Current and working knowledge of Federal Regulations, ICH /GCP guidelines
  • Thorough understanding of medical terminology and human physiology
  • Strong technical knowledge and ability to learn new systems quickly
  • Excellent oral/presentation and written communication skills
  • Ability to complete tasks efficiently and resolve problems within set timelines
  • Excellent client and customer service skills
  • Ability to mentor and instruct through audits
  • Strong organizational skills and attention to detail
  • Demonstrated flexibility and adaptability
  • Ability to work in a team environment and independently as needed
ARG is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. ARG also complies with all work authorization and employment eligibility verification requirements and is an E-Verify employer.