Business Analyst

Creative Solutions Services, LLC; Aguadilla (PR); On-site; USD 85,000 - 110,000; Full time

Job summary

Creative Solutions Services, LLC seeks an experienced Business Analyst with pharma domain expertise to bridge business and technology teams in delivering digital transformation, validation, data, and quality initiatives within regulated pharmaceutical environments.

The role requires strong knowledge of pharmaceutical processes, GxP regulations, and requirements management with cross-functional collaboration across Manufacturing, Quality, Laboratory, Supply Chain, Validation, and IT.

Qualifications

• 5–10 years of experience as a Business Analyst in the Pharmaceutical domain.
• Strong understanding of pharmaceutical business processes.
• Experience working in GxP-regulated environments.
• Knowledge of 21 CFR Part 11, GAMP 5, GDP, Change Control, CAPA, Deviations, and Validation Lifecycle (CSV).
• Experience in requirements gathering and analysis, business process mapping, gap analysis, user story creation, stakeholder management, BRD, FRD, RTM documentation, and UAT planning and execution.
• Proficiency with JIRA, Confluence, MS Visio, Microsoft Office Suite, and Client ALM/AQM (Good to Have).
• Experience handling AI projects is a plus.

Responsibilities

• Gather, analyze, and document business requirements from stakeholders.
• Facilitate workshops, requirement elicitation sessions, and process mapping activities.
• Translate business requirements into functional specifications, user stories, and acceptance criteria.
• Collaborate with business SMEs, Quality, Manufacturing, Supply Chain, Validation, and IT teams.
• Support Agile delivery teams in backlog refinement, sprint planning, and UAT activities.
• Perform gap analysis and recommend process improvements.
• Create and maintain business process flows (Visio), BRDs, FRDs, RTMs, and user stories.
• Support validation activities in GxP-regulated environments.
• Coordinate testing activities including SIT, UAT, and defect triage.
• Ensure solutions comply with pharmaceutical regulations and quality standards.
• Act as the liaison between business stakeholders and technical teams.

Job description

Job Summary:

• We are seeking an experienced Business Analyst with Pharma Domain expertise to bridge business and technology teams in delivering digital transformation, validation, data, and quality initiatives within regulated pharmaceutical environments.


• The ideal candidate should have strong knowledge of pharmaceutical business processes, GxP regulations, and requirements management, with experience working across Manufacturing, Quality, Laboratory, Supply Chain, Validation, and IT functions.

Roles & Responsibilities:

• Gather, analyze, and document business requirements from stakeholders.


• Facilitate workshops, requirement elicitation sessions, and process mapping activities.


• Translate business requirements into functional specifications, user stories, and acceptance criteria.


• Collaborate with business SMEs, Quality, Manufacturing, Supply Chain, Validation, and IT teams.


• Support Agile delivery teams in backlog refinement, sprint planning, and UAT activities.


• Perform gap analysis and recommend process improvements.


• Create and maintain business process flows (Visio), BRDs, FRDs, RTMs, and user stories.


• Support validation activities in GxP-regulated environments.


• Coordinate testing activities including SIT, UAT, and defect triage.


• Ensure solutions comply with pharmaceutical regulations and quality standards.


• Act as the liaison between business stakeholders and technical teams.

Experience:

• 5–10 years of experience as a Business Analyst in the Pharmaceutical domain.


• Strong understanding of pharmaceutical business processes.


• Experience working in GxP-regulated environments.


• Knowledge of 21 CFR Part 11, GAMP 5, Good Documentation Practices (GDP), Change Control, CAPA, Deviations, and Validation Lifecycle (CSV).


• Experience in requirements gathering and analysis, business process mapping, gap analysis, user story creation, stakeholder management, BRD, FRD, RTM documentation, and UAT planning and execution.


• Proficiency with JIRA, Confluence, MS Visio, Microsoft Office Suite, and Client ALM/AQM (Good to Have).


• Experience handling AI projects is a plus.