QMS AND REPORTING SPECIALIST
Planet Pharma · Cambridge, MA · 3 mo ago
On-siteAnalyst$41–$51/hrFull-time
Key Responsibilities
- Deviation Training Program & Support
- Model Execution Support
- Develop training materials (case studies, templates, guidance tools)
- Partner with QA and deviation owners to establish a sustainable support model
- Analyze training program effectiveness metrics
- 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
- Support routine and ad hoc reporting requests
- Provide project management support across QMS initiatives
- QMS Process Support & Technology Enablement
- Aid in process mapping, gap assessments, and continuous improvement initiatives
- Leverage approved AI tools and technologies to advance analytics
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