Quality Data Management Analyst

• Position: Quality Data Management Analyst
• Employment Type: Contract (W2)
• Location: Burlington, MA (Onsite)
• Rate: Upto $53/hr on W2

• About the Role
• Trident Consulting is seeking a Quality Data Management Analyst to support data governance, data integrity, standardization, and lifecycle management across Quality and GxP-regulated business processes.
• The ideal candidate will have experience working with Quality Systems, GxP applications, data governance, data quality, regulatory compliance, and analytics within a regulated industry such as medical devices, pharmaceuticals, biotechnology, or life sciences.

• Key Responsibilities
• Support Quality data governance frameworks, including data standards, business rules, metadata, ownership, and lifecycle controls.
• Maintain data dictionaries, data maps, data lineage, and controlled data definitions.
• Monitor and improve data quality across GxP applications, identifying duplicates, missing data, inconsistencies, and data integrity issues.
• Perform data analysis, reconciliation, cleansing, validation, and trend analysis.
• Investigate data discrepancies and support root cause analysis, CAPA, and corrective actions.
• Apply ALCOA+ data integrity principles across Quality systems, reports, extracts, and analytics.
• Support GxP systems including eQMS, LIMS, ERP, PLM, document management, training management, complaint management, and CAPA systems.
• Partner with Quality, Regulatory Affairs, Manufacturing, Supply Chain, CSV, IT/GTS, System Owners, and Business Process Owners.
• Support system implementations, upgrades, migrations, integrations, UAT, validation, and periodic reviews.
• Prepare and verify Quality data for dashboards, metrics, Management Review, Quality Review, complaint trending, CAPA monitoring, and audit reporting.
• Support internal, supplier, notified body, and regulatory audits involving Quality data, electronic records, computerized systems, and data integrity.
• Drive continuous improvement initiatives involving data quality, automation, reporting, and data harmonization.
• Leverage appropriate automation and AI-enabled technologies to improve efficiency, compliance, and data accessibility.

• Required Qualifications
• 3+ years of experience in Quality Systems, Data Management, Data Analytics, Regulatory Affairs, Information Management, or a related function within a regulated industry.
• Hands-on experience with GxP-regulated systems and data.
• Experience with data quality, data reconciliation, data cleansing, data analysis, and issue investigation.
• Experience supporting system implementations, data migrations, integrations, validation, or regulated system changes.
• Knowledge of data governance, master data management, data lifecycle management, and data integrity.
• Strong understanding of ALCOA+ principles.
• Strong analytical, problem-solving, documentation, and communication skills.
• Ability to identify data trends, investigate discrepancies, and recommend practical solutions.

• Preferred Qualifications
• Experience with FDA regulations, 21 CFR Part 11, ISO 13485, EU MDR, and EU Annex 11.
• Experience with eQMS, LIMS, ERP, PLM, CAPA, Complaint Management, Document Management, or Training Management systems.
• Experience with Power BI, Tableau, Google Cloud Platform, or similar analytics platforms.
• Experience supporting CSV, UAT, data validation, audits, and regulatory inspections.
• Experience with data lineage, data mapping, metadata, and enterprise data harmonization.
• Exposure to automation, AI, or emerging technologies in regulated environments.

• About Trident Consulting
• Trident Consulting is an award-winning staffing and consulting firm headquartered in San Ramon, CA. Since 2005, we’ve partnered with Fortune 500 and high-growth companies to deliver high-quality talent across technology, engineering, business operations, and professional services.

We specialize in contract, contract-to-hire, and direct hire placements, supporting roles across IT, data & analytics, cloud, cybersecurity, finance & accounting, HR, operations, and more. With a strong focus on hard-to-fill and niche positions, our global recruiting engine enables us to deliver speed, quality, and scale.