QA Database Administrator

Job title: QA Database Administrator

About the Role QA Database Administrator role supports internal audit of drug quality sampling and testing databases to ensure data integrity, regulatory compliance, and methodological consistency within a federal client environment. The DBA will assess data quality and assist regulatory decision-making.

What You'll Do

• Perform comprehensive reviews of database records and database maintenance to evaluate completeness, accuracy, and consistency in coordination with Quality Assurance Data Auditor Lead.
• Analyze variations in sampling and testing data ingestion/export pathways and assess impacts to data quality and integrity across data sources and systems.
• Verify data traceability from sample collection through final testing results.
• Utilize ETL tools and data queries to identify duplicate or missing entries along with any data anomalies.
• Assess completeness of analytical method documentation and data to determine data gaps or data integration errors.
• Assess compliance of documentation and data controls with FDA regulations, guidance, information security and standard operating procedures.
• Evaluate completeness, and consistency and gaps in supporting documentation associated with testing activities and system documentation.
• Identify deviation, inconsistencies from established processes and risks impacting regulatory decisions.
• Conduct comprehensive data quality assessment to detect trends, data anatomies and performance variations in procedures and their potential impact on data quality.
• Generate assessment records, gap analysis and final assessment and improvements report under the guidance of the QA Data Auditor Lead and Client Program Manager.

What We're Looking For

• Bachelor’s Degree, relevant experience may be substituted for formal education.
• Minimum five (5) years of relevant experience in federal information systems management, data management and database administration.
• Demonstrated ability to define data integration problems and analyze complex systems within regulatory or scientific domains.
• Experience developing analysis plans, evaluating data quality, and information security compliance.
• Strong knowledge of FDA regulations, data integrity principles and regulatory documentation standards.
• Ability to assess systems and regulatory data controls in a healthcare/pharmaceutical quality context.