QMS and Reporting Specialist
Proclinical Staffing
QMS and Reporting Specialist - Contract - Cambridge, MA Drive data‑led quality excellence and continuous improvement across a dynamic QMS landscape. Proclinical is seeking a QMS and Reporting Specialist to support quality management system (QMS) initiatives and reporting deliverables within the pharmaceutical industry. This is an exciting opportunity for someone passionate about quality systems and continuous improvement. Primary Responsibilities The successful candidate will collaborate with GxP stakeholders to enhance deviation training programs, improve quality metrics, and support QMS processes through data analysis and technology enablement. Skills & Requirements Bachelor's degree in Life Sciences, Engineering, or a related discipline. Experience in GxP Quality Systems, QA operations, or QMS program support. Strong understanding of GMP, GLP, GCP regulations, and ICH guidelines. Proficiency in quality metrics, dashboards, and KPI development. Skilled in data analysis and trending using tools like Excel or Power BI. Familiarity with electronic quality management systems (e.g., Veeva preferred). Strong process thinking, analytical, and project management skills. Excellent communication, facilitation, and technical writing abilities. Ability to influence without direct authority and work independently. Experience with AI‑enabled tools while ensuring GxP compliance and data integrity principles is a plus. Responsibilities Support the implementation of a deviation investigator training pilot program, including developing training materials, case studies, templates, and guidance tools. Partner with QA and deviation owners to establish sustainable support models, such as office hours, coaching, and knowledge resources. Analyze training program effectiveness using metrics like investigation quality, cycle times, and rework trends to drive improvements. Execute and deliver quality scorecards, dashboards, and KPI frameworks. Perform data aggregation, trending, and root‑cause analysis across deviations, CAPAs, and change controls. Support routine and ad‑hoc reporting requests for Quality Management Review and Quality Systems forums. Assist with process mapping, gap assessments, and continuous improvement initiatives across QMS processes. Support data governance and clean‑up initiatives within the QMS. Leverage approved AI tools and technologies to enhance analytics and ensure quality record accuracy. #J-18808-Ljbffr Proclinical Staffing
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