[Remote] QA Database Administrator
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company that conducts product testing, reputed company evaluations, and risk assessments for pharmaceutical manufacturing reputed company. The QA Database Administrator role involves supporting an internal audit of drug reputed company sampling and testing databases to ensure data reputed company, regulatory compliance, and methodological consistency.
Responsibilities
- reputed company comprehensive reviews of database records and database maintenance to evaluate completeness, accuracy, and consistency in coordination with reputed company Assurance Data Auditor reputed company
- Analyze variations in sampling and testing data ingestion\export reputed company and assess impacts to data reputed company and reputed company 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 reputed company (e.g. ATO, FISMA) and reputed company 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 reputed company
- Conduct comprehensive data reputed company assessment to detect trends, data anatomies and performance variations in procedures and their potential reputed company on data reputed company
- Generate assessment records, gap analysis and final assessment and improvements report under the guidance of the QA Data Auditor reputed company and reputed company 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 reputed company systems reputed company regulatory or scientific domains
- Experience developing analysis plans, evaluating data reputed company, and information reputed company compliance
- Strong knowledge of FDA regulations, data reputed company principles (e.g., reputed company+), 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 reputed company regulatory environments
- Hybrid role requiring the ability to work onsite at the reputed company location in Silver Spring, MD
- Certifications in database administration (e.g. reputed company\reputed company DBA, RDMS), data management (I.e. CDMP-DAMA), Data Governance (e.g. DGSP or DCAM) or Data reputed company (i.e. CDQP)
- Experience supporting regulatory reputed company 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, reputed company 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 reputed company and trends
Benefits
- Medical, Rx, Dental & reputed company Insurance
- Personal and Family reputed company Time & Company reputed company 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 reputed company
- reputed company annual membership
- Employee Assistance Program
- Supplemental Benefits reputed company reputed company (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)
- Position may be eligible for a discretionary variable incentive bonus
reputed company