Business Analyst (EDI) Insight Global
Bridgewater, NJ17 days ago
- $30–$37 Per Hour
- Contractor
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Skills
- Biologyunmatched
- Biotech and Pharmaceuticalunmatched
- Business Analysisunmatched
- Business Supportunmatched
- Code of Federal Regulationsunmatched
- Communication Skillsunmatched
- Design Documentunmatched
- Functional Testingunmatched
- GxPunmatched
- Insurance Regulationsunmatched
- Presentation/Verbal Skillsunmatched
- Quality Assuranceunmatched
- Regulationsunmatched
- Regulatory Complianceunmatched
- Requirements Managementunmatched
- Use Casesunmatched
- Writing Skillsunmatched
Description
Job Summary:
- We are seeking a Senior Business Analyst Veeva Vault Quality to support Business & Technology Integration for Veeva Quality Docs/QMS implementation within the Life Sciences domain.
- The role is responsible for gathering business requirements, creating user stories, designing workflows, ensuring CSV alignment, and serving as the liaison between Business and IT teams in a GxP-regulated environment.
- Drive end-to-end business analysis across Veeva Quality Docs and QMS implementation and enhancement projects.
- Gather, document, and validate business and functional requirements for Veeva Quality Docs and QMS modules.
- Convert quality processes into user stories, use cases, and functional specifications.
- Plan and lead workshops and interviews with stakeholders across Quality Assurance, Regulatory Affairs, and Compliance.
- Align stakeholder groups on project scope and priorities while managing competing interests.
- Partner with Veeva technical consultants and configuration teams to ensure accurate delivery of requirements.
- Support the design of document lifecycle workflows and training record structures within Quality Docs.
- Ensure alignment with GxP, 21 CFR Part 11, and CSV compliance principles.
- 10+ years of experience with Veeva Vault Quality Docs/QMS.
- 10+ years of Business Analysis experience within the Pharmaceutical/Life Sciences industry.
- 6+ years of experience with GxP, 21 CFR Part 11, and CSV compliance.
- Experience with stakeholder management across QA and Regulatory Affairs.
- Experience in document lifecycle workflow design.
- Veeva Vault Certification is preferred.
- Strong written and verbal communication skills.
Numbers & Facts
| Location | Warren, NJ |
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