Quality Assurance Specialist

Location: Madison, WI

Description

Frontier Science Foundation (FSF) has three offices in the United States that operate under one central Quality Management System (QMS). In addition, each office maintains process-specific standard operating procedures (SOPs) and quality documentation pertaining to each office’s work flow. The primary responsibility of the Quality Assurance Specialist is to assist in the continuing development and maintenance of the portions of FSF’s QMS which pertain to the Madison office, as well as contribute to the overall efforts of the central QMS. The process-specific procedures of the Madison office have been developed in the context of its core process, which is providing statistical services to independent Data Monitoring and Safety Boards (DSMB) of various clinical trials. This individual must be able to oversee the FSF QMS activities of the Madison office and related documentation to ensure that SOPs are updated and reviewed on schedule, must be able to represent the office during external audits, and must collaborate with other quality personnel to ensure that FSF compliance requirements are addressed within the Madison location.

Major Duties and Responsibilities:

  • Oversee the FSF QMS activities of the Madison office
    • Maintain guidance documents and ensure they are updated appropriately (versioning, signatures, approvals, sign off, etc.)
    • Act as the primary coordinator and liaison for external audits while keeping the FSF compliance officer informed as well and following FSF organizational policy
    • Conduct internal audits as necessary, including trial master file (TMF) review
    • Intake, monitor, and track the completion of vendor survey
    • Train office staff as necessary on various compliance issues relevant to the work conducted by the office
    • Maintain a current knowledge of regulations, good practices, and other external standards
    • Assist fellow QA personnel with QMS activities of other offices
  • Meetings
    • Regular meetings with QA personnel in other offices
    • Regular meetings with Madison Quality Task Force
    • May take minutes from meetings

Reports to: Madison Office Director; organizational assignments from the FSF compliance officer.

Controls over position:

The Quality Assurance Specialist performs tasks as required by the Madison Office Director and/or the Compliance Officer. The Quality Assurance Specialist also performs duties as defined in SOPs or work instructions.

Required Qualifications:

  • B.A. or B.S. required
  • Familiarity with general clinical trial best practices for data management, statistics and Good Clinical Practice (GCP) guidelines
  • Familiarity with Federal regulations affecting clinical trial data management and statistical work such as relevant FDA regulations and 21 CFR Part 11
  • 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
  • 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
  • The ability to be a team player and build effective relationships and work with people from diverse backgrounds, work independently, multi-task, adapt to changing priorities, perform job duties with minimal guidance, and meet deadlines

Please send a resume, cover letter, and three references to jobs@fstrf-wi.org. You may also send your resume, cover letter and three references to Carla Fears at Frontier Science Madison, 440 Science Drive, Suite 401 Madison, WI 53711. Please visit our website at www.fstrf-isc.org

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