QA Database Administrator

This is a fully remote position, open to applicants in Maryland.

📋 Description

• Conduct thorough evaluations of database records and maintain databases to ensure completeness, accuracy, and consistency in collaboration with the Quality Assurance Data Auditor Lead.

• Examine discrepancies in sampling and testing data ingestion/export pathways and evaluate their effects on data quality and integrity across various data sources and systems.

• Confirm data traceability from sample collection to final testing outcomes.

• Employ ETL tools and data queries to detect duplicate or missing entries and identify any data anomalies.

• Evaluate the completeness of analytical method documentation (such as analyst worksheets and supporting materials) and data to identify data gaps or integration issues.

• Review compliance of documentation and data controls with FDA regulations, guidance, information security (including ATO and FISMA), and standard operating procedures.

• Assess completeness, consistency, and gaps in supporting documentation related to testing activities and system documentation.

• Identify deviations and inconsistencies from established processes, as well as risks that could impact regulatory decisions.

• Perform comprehensive data quality assessments to uncover trends, data anomalies, and performance variations in procedures and their potential implications for data quality.

• Produce assessment records, gap analyses, and final assessment and improvement reports under the supervision of the QA Data Auditor Lead and Client Program Manager.

⛳️ Requirements

• Bachelor's Degree, with relevant experience being a potential substitute for formal education.

• At least five (5) years of pertinent experience in federal information systems management, data management, and database administration.

• Proven capability to identify data integration issues and analyze complex systems within regulatory or scientific contexts.

• Experience in developing analysis plans, assessing data quality, and ensuring information security compliance.

• In-depth understanding of FDA regulations, data integrity principles (such as ALCOA+), and regulatory documentation standards.

• Ability to evaluate system specifications and suggest enhancements for implementation.

• Exceptional written and verbal communication abilities, including the preparation of status reports, technical documents, and audit records.

• Strong critical thinking and problem-solving skills in intricate regulatory environments.

🏝️ Benefits

• Medical, Rx, Dental & Vision Insurance

• Personal and Family Sick Time & Company Paid Holidays

• Parental Leave

• 401(k) Retirement Plan

• Group Term Life and Travel Assistance

• Voluntary Life and AD&D Insurance

• Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts

• Transit and Parking Commuter Benefits

• Short-Term & Long-Term Disability

• Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities

• Employee Referral Program

• Corporate Sponsored Events & Community Outreach

• Care.com annual membership

• Employee Assistance Program

• Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance, and ID theft protection, etc.)