QMS and Reporting Specialist

Cambridge, Massachusetts
June 11, 2026
$52 / hour
Contract
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Job Description

Job Summary:

  • The QMS and Reporting Support Contractor position within AIQ will serve as an enabler of multiple QMS initiatives, as well as support reporting and data analysis deliverables.
  • This individual will report into the QMS and Reporting pillar of AIQ and partner with various GxP stakeholders who provide data input and deviation record ownership.

Duties and Responsibilities:

1. Deviation Training Program & Support Model Execution:

  • Support implementation of a deviation investigator training pilot program, incorporating adult learning principles and hands-on application.
  • Develop training materials (case studies, templates, guidance tools) to improve investigation quality and consistency.
  • Partner with QA and deviation owners to establish a sustainable support model (office hours, coaching, knowledge resources).
  • Analyze training program effectiveness metrics (e.g., quality of investigations, cycle times, rework trends) to inform program improvements and scalability.

2. Quality Metrics, Scorecard & KPI Enhancement:

  • Support execution and delivery of Quality scorecards, dashboards, and KPI frameworks.
  • Perform data aggregation, trending, and root-cause-oriented analysis across deviations, CAPAs, and change controls.
  • Support routine and ad hoc reporting requests for Quality Management Review and Quality Systems forums, ensuring data accuracy and consistency.
  • Provide project management support across QMS initiatives (timelines, deliverables, stakeholder follow-ups).

3. QMS Process Support & Technology Enablement:

  • Assist with process mapping, gap assessments, and continuous improvement initiatives across QMS processes.
  • Support data governance and data clean-up initiatives within the QMS.
  • Leverage client-approved AI tools and technologies to advance analytics and enable Quality record completeness and accuracy.

Qualifications:

  • Bachelor’s degree in Life Sciences, Engineering, or related discipline.
  • ~ 3-5 years of experience in GxP Quality Systems, QA operations, or QMS program support.
  • Strong understanding of GMP, GLP, GCP regulations and ICH guidelines.

Demonstrated experience with:

  • Quality Management System processes.
  • Quality metrics, dashboards, and KPI development.
  • Data analysis and trending (Excel, Power BI, or equivalent tools).
  • Electronic quality management systems (Veeva strongly preferred).

Preferred Qualifications:

  • Bachelor’s degree in related field.
  • Experience with electronic Learning Management Systems and Document Management Systems.
  • Experience with change management and organizational development.

Key Competencies:

  • Strong process thinking and analytical skills.
  • Strong experience in Excel.
  • Excellence in project management and organization.
  • Strong communication and facilitation skills.
  • Ability to influence without direct authority and self-starter.
  • Strong technical writing skills.
  • Demonstrated ability to leverage AI-enabled tools while ensuring GxP compliance and data integrity principles.

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