US - Remote (Any location) · Remote
Full-time
Mid level
2 months ago
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Salary undisclosed
Job Family : Database Administration Travel Required : Up to 10% Clearance Required : Ability to Obtain Public Trust Our federal client conducts product testing, quality evaluations, and risk assessments to support market interventions and ensure pharmaceutical manufacturing quality. The associated data repository serves as a critical system of record underpinning regulatory decision-making for pharmaceutical products. This role supports an internal audit of drug quality sampling and testing databases to ensure data integrity, regulatory compliance, and methodological consistency. The DBA will assess data quality, validate adherence to FDA standards, information management compliance and provide actionable recommendations to strengthen regulatory decision-making processes. What You Will 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 (e.g., review analyst worksheets and supporting documentation) and data to determine data gaps or data integration errors. Assess compliance of documentation and data controls with FDA regulations, guidance, information security (e.g. ATO, FISMA) 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 You Will Need: Bachelor’s Degree, r elevant 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 (e.g., ALCOA+), and regulatory documentation standards. Ability to assess system specifications and recommend improvements for implementation. Excellent written and verbal communication skills, including status reports, technical reports and audit documentation. Strong critical thinking and problem-solving capabilities in complex regulatory environments. Hybrid role requiring the ability to work onsite at the client location in Silver Spring, MD. What Would Be Nice To Have: Certifications in database administration (e.g. Oracle\Microsoft DBA, RDMS), data management (I.e. CDMP-DAMA), Data Governance (e.g. DGSP or DCAM) or Data Quality (i.e. CDQP). Experience supporting regulatory quality surveillance initiatives, data systems and data management practices. Experience conducting internal audits or supporting regulatory inspections (e.g., FDA, ISO, GLP). Knowledge of database systems used for laboratory data management (e.g., LIMS), scientific instruments and laboratory equipment. Experience with data governance, quality frameworks, and process improvement methodologies. Experience translating audit findings into operational and system-level improvements. Exposure to advanced analytics tools to conduct research, evaluate
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