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QMS and Reporting Specialist

Integrated Resources, Inc

Cambridge, MA

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JOB DETAILS
SKILLS
Adult Learning, Analysis Skills, Artificial Intelligence (AI), Biology, Change Control, Change Management, Coaching, Communication Skills, Continuous Improvement, Data Analysis, Data Cleaning, Data Collection, Data Entry, Data Quality, Document Management, Financial Reporting, GCP (Good Clinical Practices), GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), GxP, Hyperion Pillar, Learning Management System (LMS), Maintain Compliance, Metrics, Microsoft Excel, Organizational Development/Management, Performance Metrics, Power BI, Project/Program Management, QA Partner Testing Software, Quality Assurance, Quality Management, Quality Metrics, Reporting Dashboards, Scorecarding, System Operations, Technical Support, Technical Writing, Training Program, Training Program Evaluation, Trend Analysis, Writing Skills, eLearning
LOCATION
Cambridge, MA
POSTED
26 days ago

Specialist/Sr. Specialist - Global Audits, Inspections, and QMS (AIQ)

Position Overview
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.
Key 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
Remote/Onsite: Hybrid

About the Company

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Integrated Resources, Inc