Quality Assurance Specialist

Location: Amherst, NY


Under the direction of our Compliance Officer, the primary responsibility will be to assist in the continuing development and maintenance of an Internal Assessment Program (IAP). The program requires a regular schedule of assessments and reporting of those assessments. Because an IAP needs continuous review and improvement, the QA Specialist should be willing to make suggestions to the program itself and may be asked to develop metrics to assess the adequacy of the program overall.

Duties include:

  • Assist in Incident Management, including CAPA processing and monitoring
    • Manage breach and incident tickets
    • Complete incident documentation, in consultation with QA personnel in Amherst
    • Draft resulting CAPA Action Logs
    • Assist in scheduling CAPA log reviews
    • Maintain Corporate Incident and CAPA Log
    • Identify incident trends for further investigation
    • Recommend process improvement based on CAPA intake
    • Create and utilize risk management tools to prioritize CAPA activities and to identify high risk incidents for immediate processing
    • Review, and potentially draft, software validation deliverables for errors or inconsistencies
    • Draft Quality Department guidance documents and templates
    • Curate Internal QA documentation folders
  • Meetings
    • Regular meetings with QA personnel in Amherst and other offices
    • Attend Compliance Committee meetings and interact with core leadership at Amherst location to advise of compliance and other updates, including status of CAPA program
    • May take minutes from meetings
  • Audits
    • Assist Quality Department in audit readiness and preparation responsibilities
    • Work with other core departments to help them with audit preparation activities and assist coordination of audit response efforts

Education & Skills:

  • B.A. or B.S. required
  • Some experience in a quality assurance role, preferably within a GCP environment, although GMP experience may be considered, including CAPA process management
  • 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
  • Strong writing skills are mandatory
  • Basic understanding of Trial Master File (TMF) requirements
  • Experience with database design and/or software programming quality assurance is a plus
  • The Ability to 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

Submit resumes to jobs@fstrf.org and include QASpec20190419 in the subject line.

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