Qms And Reporting Specialist

Location

Cambridge, Massachusetts

Category:
Quality and Compliance

Salary:
Apply for details

Country:
United States

Employment:
Contract

Worksite:
On‑Site

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.

• 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 (quality of investigations, cycle times, rework trends) to inform program improvements and scalability.
• 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).
• 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 approved AI tools and technologies to advance analytics and enable Quality record completeness and accuracy.

• 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)

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

• 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

Pay ranges between $41–51/hr based on experience.

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations.

It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate.

We believe diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore appropriate arrangements.