GxP Data Analyst

We are looking for a talented GxP Data Analyst to provide support in developing and implementing data repositories and analytics tools for pharmaceutical regulated GMP and clinical data. We are a biotechnology company pioneering novel autologous cell therapies.

• Work Location: 100% Remote
• Employment Type: Contract
• Rate Range: $55-$65/hr W2

This role is NOT eligible for visa sponsorship or C2C

• Identify, classify, and map data sources while building data lineage diagrams from source systems to analytics-ready datasets.
• Determine data curation requirements to organize, clean, and manage data for manufacturing, quality, and clinical analytical use cases.
• Support technical activities including data integration, architecture design, and data transformation/processing.
• Develop data governance standards and key project documentation such as user requirements and configuration specifications.
• Lead the development and execution of test scenarios, scripts, and protocols in collaboration with validation teams.
• Monitor test execution, communicate results to address defects, and support training activities for business users.
• Support the development of SOPs and training materials required for system go-live and ongoing administration.

• 5+ years of IT experience in business or technical analyst roles focused on data, BI, and analytics initiatives.
• 5+ years of experience working in biotech or pharmaceutical GxP regulated environments.
• Hands‑on experience with data analysis and reporting within pharmaceutical GMP environments and FDA-regulated validation (21 CFR Part 11).
• Strong understanding of LIMS, QMS, MES, data historians, EDC, and safety databases.
• Technical proficiency with SQL, ETL development, and cloud environments (AWS or Azure).
• Experience with analytics tools such as Python, R, Tableau, Spotfire, or process analytics software like Seeq.
• Bachelor’s degree required.

• Opportunity to work at the forefront of autologous cell therapy and chronic kidney disease innovation.
• 100% remote work flexibility.
• High-impact role supporting critical clinical and manufacturing data analytics.
• Collaborative environment working across cross‑functional technical and clinical teams.

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay