Note: The job is a remote job and is open to candidates in USA. Guidehouse is a company that supports federal clients in ensuring pharmaceutical manufacturing quality. The QA Database Administrator role involves auditing drug quality sampling and testing databases to ensure data integrity and regulatory compliance, while providing actionable recommendations for improvement.
Responsibilities
- 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
Skills
- 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 (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
- 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 data integrity and trends
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.)
- Position may be eligible for a discretionary variable incentive bonus
Company Overview