Business Analyst

Business Analyst

Duration: 6+ Months Location: Bridge Ridge, NJ (Non-local open for relocation) In office 1 day per week or as needed, must be local to Basking Ridge, NJ.

Key Responsibilities:

• Lead Requirement Gathering: Facilitate sessions with stakeholders from Quality, Regulatory, R&D, Clinical, and IT to gather and document business requirements.
• Translate Business Needs: Convert complex business requirements into detailed user stories, functional specifications, and process flows.
• Ensure Compliance: Guarantee that all solutions and processes adhere to GxP, CSV (Computer System Validation), and 21 CFR Part 11 regulations.
• Collaborate on Solutions: Work closely with solution architects and data engineers to design scalable and compliant AWS-based data solutions.
• Data Validation: Write and execute complex SQL queries for data validation, root cause analysis, and support User Acceptance Testing (UAT).

Qualifications:

• Experience: Minimum of 5 years in Business Analysis, with significant experience in Life Sciences/Pharma.
• GxP Knowledge: Strong hands-on experience with GxP frameworks, CSV, and regulatory audit preparedness.
• SQL Proficiency: Proficient in SQL for data profiling, validation, and reconciliation, ideally with Redshift, PostgreSQL, or Oracle.
• AWS Experience: Familiarity with the AWS cloud ecosystem, including services such as S3, Redshift, DBeaver, or Athena.
• Documentation Skills: Excellent documentation capabilities (BRD, FRS, Data Mapping, SOPs, Validation Plans) and experience in Agile environments using tools like JIRA, Confluence, and MPP.