Quality Assurance Specialist

Location: Amherst, NY

Frontier Science Foundation is a clinical data management and statistical center with three office locations in the United States, seeking to add a Quality Assurance Specialist to its quality team. Under the direction of our Compliance Officer, the primary responsibility of the QA Specialist will be to assist in the continuing development and maintenance of the organization’s Quality Management System, including incident management, audit management (external and internal), systems validation, and working in the electronic QMS. This individual will reside in the Amherst office but will lend assistance to the Frontier Science Boston Office as well, becoming the primary QA liaison for the biostatisticians in that location. The QA Specialist will work with other members of the Quality Assurance team to ensure that the QMS is properly managed and improved, that all QA deliverables are completed as required, and that the QA team is able to effectively manage its various roles and responsibilities within the organization as a whole. Please note that the position will remain remote until further updates regarding COVID-19 have been released by the Frontier Science Foundation Leadership Team.

Duties include:

  • Assist in cross office compliance efforts
    • Work with office leaders to define compliance needs
    • Conduct assessments (IAPs) and/or Gap Assessments
    • Build, enforce, and improve QMS infrastructure where required
    • Regular meetings with QA personnel in Amherst and other offices
  • QMS Infrastructure Support
    • Ensure success of current quality initiatives by working with a cross office team of QA experts
    • Assist with incident management, CAPA management, and implementation of electronic quality management system (eQMS)
    • Conduct internal audits and recommend procedure improvements
    • Track, monitor, and gather metrics from internal audits and incident management activities
    • Provide support to other QA team members and Project Leads
    • Assist in oversight of quality software validation efforts, specifically for commercial systems
    • Maintain knowledge and expertise in regulations, trends, and industry best practices affecting the clinical research good clinical practices (GCP) environment

Education & Skills

  • B.A. or B.S. required
  • Familiarity with general clinical trial best practices for data management and Good Clinical Practice (GCP) guidelines
  • Familiarity with Federal regulations affecting clinical trial data management work such as relevant FDA regulations and 21 CFR Part 11
  • Ability to work independently while managing a large number of competing deadlines
  • Ability to read and comprehend industry literature, especially for quality assurance and general compliance topics, and to conduct research to facilitate answers to compliance inquiries
  • Strong writing skills and the ability to produce documentation using proper English and grammar and in a manner to be understood by general staff and management
  • Enthusiastic personality, and willing to propose new suggestions and ideas to further improve quality functions
  • Excellent communication and interpersonal skills, along with the ability to facilitate discussion and gather information for the development of documentation or other quality assurance materials
  • Resourceful, positive and professional demeanor

Applications will be received through the ADP Workforce Now Career Center using the following link: ADP Workforce Now Frontier Science Career Center. A cover letter must be submitted to be considered for this position.

All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, disability, age, or veteran status.