Quality Data Management Analyst

Responsibilities

• Support governance, integrity, standardization, and lifecycle management of Quality data across GxP-regulated business processes
• Maintain data dictionaries, data maps, lineage documentation, and controlled definitions supporting Quality metrics, dashboards, and reports
• Monitor data quality across GxP applications to identify inconsistencies, inaccuracies, duplicates, and integrity concerns
• Perform data assessments, reconciliation, cleansing support, and trend analyses; investigate discrepancies and support root cause/CAPA activities
• Promote adoption of ALCOA+ data integrity principles across Quality systems and reports
• Support data-related activities for enterprise GxP systems (eQMS, document/training management, complaint handling, ERP, PLM, LIMS)
• Partner with System Owners, CSV, Digital Quality, and GTS during implementations, upgrades, migrations, and system changes
• Support UAT, data migration verification, and evaluation of system changes for data quality/reporting impacts
• Support extraction and verification of Quality data for Management Review, complaint trending, CAPA monitoring, and audit metrics
• Support internal/supplier/notified body audits and regulatory inspections involving Quality data and data integrity
• Lead or support continuous improvement initiatives focused on data quality, automation, and data harmonization

Requirements

• 3+ years of experience in Quality Systems, Data Management, Data Analytics, Regulatory Affairs, or related functions in a regulated industry
• Experience with GxP software applications and regulated data (eQMS, ERP, PLM, LIMS, document/training management, complaint handling, CAPA)
• Experience with data analysis, reconciliation, cleansing, issue investigation, and quality improvement
• Knowledge of data governance, master data management, and data integrity principles
• Strong analytical, organizational, and documentation skills with high attention to detail
• Nice to have: experience with system implementations/migrations/validation; familiarity with FDA, ISO 13485, EU MDR, 21 CFR Part 11, EU Annex 11, ALCOA+; experience with Power BI, Tableau, or similar tools

Benefits

• Eastridge Workforce Solutions offers the following benefits, subject to applicable eligibility requirements. Use this link https://applicantcenterstorage.blob.core.windows.net/public-documents/EWSb1cb390e-729b-47eb-ab2f-b92adafbdd07-2024EplicaBenefitSummaryTempExternal.pdf to learn more about benefits available to Eastridge’s temporary employees.
• Due to the varying length(s) of temporary assignments, Eastridge Workforce Solutions’ Temporary Staff are not eligible for paid time off, unless required by applicable state law in which the position is based.
• However, from time to time Eastridge’s clients may offer additional benefits to Eastridge employees while on assignment. Information about those benefits will be communicated when applicable.

Pay

The hourly rate for this position is expected to be between $48.56 – $53.36 per hour, depending on geographic location, experience and other qualifications of the successful candidate.

Schedule

Monday–Friday, 8:00 AM–5:00 PM

Location: Burlington, MA. Employment type: Temporary, approximately 6 months.