Quality Assurance Documentation Specialist

Location: Amherst, NY

The primary responsibility of the QA Documentation Specialist is to assist in the maintenance and monitoring of incident documentation and CAPA activities. This includes incident assessments, incident reports, and CAPA Logs. This individual must feel comfortable engaging in root cause analysis as incidents are reported for intake, and recommend process improvements as needed. The role will also eventually be required to develop metrics to assess the adequacy of the program overall.

The QA Documentation Specialist will be required to review, as needed, various Software Development Life Cycle deliverables and other Quality Assurance department deliverables.

Major Duties and Responsibility:

  • 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
    • Follow up with core support department leaders and project leaders to ascertain status of pending CAPA activities
  • Documentation
    • Review, and potentially draft, software validation deliverables for errors or inconsistencies
    • Draft Quality Department guidance documents and templates
    • Curate Internal QA documentation folders
  • Meetings
    • Attend Compliance Committee meetings and interact with core leadership at Amherst location to advise of compliance and other updates, including status of CAPA program
    • Regular meetings with QA personnel in Amherst and other offices
    • May take minutes from meetings
  • Metrics
    • Compile reports on metrics for distribution to Compliance Committee
    • Compile other metrics as identified by Compliance Committee/QA personnel
  • 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

Required qualifications:

  • B.A. or B.S. required
  • At least two (2) years of experience in a quality assurance role, preferably within a GCP environment, although some 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
  • 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

Preferred Skills and Experience:

  • Experience with computer systems validation, specifically within the context of a GCP or GxP environment
  • Experience with ISO 9001:2015 certification is a plus
  • Familiarity with Federal regulations affecting clinical trial data management 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
  • 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 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

This position is located in our Amherst, NY office and cannot be done remotely.

Email resume/cover letter to jobs@fstrf.org and include QASpec202002 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.