Business Analyst — Pharmaceutical Domain

Job overview

The Business Analyst — Pharmaceutical Domain role is onsite in Puerto Rico; the listing provides ZIP code 00604 but no city name. Compensation is not specified. The role supports digital transformation, validation, data, and quality initiatives in regulated pharmaceutical environments. The analyst connects business and technology teams by eliciting requirements, documenting processes, and supporting testing and validation. This work helps ensure solutions meet business needs and comply with pharmaceutical regulations and quality standards.

What you'll do

• Gather and document stakeholder requirements
• facilitate workshops and process mapping
• translate requirements into specifications, user stories, and acceptance criteria
• collaborate with business, Quality, Manufacturing, Supply Chain, Validation, and IT teams
• support Agile planning and UAT
• perform gap analysis
• maintain process flows and requirements documentation
• support GxP validation, testing, defect triage, and regulatory compliance.

What we're looking for

Skills & competencies

business analyst

puerto rico

karwell technologies

pharmaceutical domain

gxp

21 cfr part 11

gamp 5

requirements gathering

process mapping

uat

validation

quality initiatives

Work arrangement

• Weekend coverage required

Why this role

Requires five to ten years of pharmaceutical-domain business analysis experience and familiarity with GxP, 21 CFR Part 11, GAMP 5, change control, CAPA, deviations, and validation lifecycle practices.

About the employer

Karwell Technologies is hiring for this role. Industry: Administrative Management and General Management Consulting Services. Sector: 54.