Business Analyst – Pharmaceutical Systems & Process Improvement
GC OR USC on W2 only
FULLTIME
Job Summary
Business Analyst – Pharmaceutical Systems & Process Improvement
Position: IT Business Analyst
Industry: Pharmaceutical / Life Sciences
Experience: 7+ years
Role Summary
We are seeking a technically strong IT Business Analyst who can bridge business operations, enterprise systems, and software development teams.
The ideal candidate must have 7+ years of relevant IT experience, including prior hands-on software development experience, strong expertise in Jira and Confluence, and experience with at least one or preferably two enterprise platforms such as NetSuite, DataNinja MES, or MasterControl.
This is a technical Business Analyst role, requiring someone who can understand both business processes and the underlying technology needed to implement and automate them.
Key Responsibilities
- Gather, analyze, and document business, functional, and technical requirements.
- Create BRDs, functional requirements, user stories, acceptance criteria, and technical requirements.
- Develop As-Is/To-Be workflows, process maps, swimlane diagrams, and system/data-flow diagrams.
- Translate business requirements into actionable development tasks in Jira.
- Maintain requirements, process documentation, technical documentation, decisions, and project knowledge in Confluence.
- Work directly with developers to clarify requirements, evaluate technical feasibility, and support solution design.
- Understand and document APIs, integrations, data flows, system interfaces, and business rules.
- Serve as the bridge between business stakeholders, IT/development teams, QA, and external vendors.
- Support enterprise system implementation, configuration, integration, and enhancement activities.
- Coordinate UAT, defect management, retesting, and business sign-off.
- Support development of SOPs, work instructions, and system/process documentation.
- Identify opportunities for automation, system integration, and AI-enabled process improvements.
- Support implementation readiness, training, change management, and post-go-live activities.
Mandatory Requirements
- 7+ years of relevant IT experience, including Business Analyst, Systems Analyst, and/or software development responsibilities.
- Must have prior hands-on software development experience before or alongside transitioning into a Business Analyst role.
- Strong understanding of SDLC, application architecture, databases, APIs, integrations, and data flows.
- Advanced hands-on expertise in Jira and Confluence.
- Experience with at least 1–2 of the following:
- Oracle NetSuite – ERP, Manufacturing, Inventory, Procurement, Finance, or related modules.
- DataNinja MES or another MES / Electronic Batch Record (EBR) platform.
- MasterControl or another pharmaceutical eQMS platform.
- Strong experience with requirements gathering, stakeholder workshops, process mapping, user stories, and acceptance criteria.
- Ability to communicate effectively with both business stakeholders and software developers/technical teams.
- Experience supporting system implementation, integration, testing, UAT, and production deployment.
Preferred Qualifications
Experience within pharmaceutical, biotech, healthcare, manufacturing, or another regulated industry is strongly preferred.
Knowledge of GxP, cGMP, 21 CFR Part 11, CSV/CSA, change control, CAPA, and validated computerized systems is highly desirable.
Experience or exposure to Azure, APIs, SQL/databases, system integrations, Power BI, workflow automation, or AI/GenAI solutions would be an advantage.
Ideal Candidate Profile
We are specifically looking for a technical Business Analyst rather than a documentation-only BA.
The candidate should have enough development experience to understand how applications are built, how systems communicate through APIs and integrations, how data moves between systems, and what developers need to successfully implement a requirement.
They should be capable of taking a business problem from:
Business Need → Process Analysis → Requirements → Solution Design → Jira/User Stories → Development → Testing/UAT → Implementation → Documentation
Critical Requirement: 7+ years of IT experience + prior software development experience + strong Jira/Confluence expertise + experience with at least one, preferably two, of NetSuite, MES/DataNinja, or MasterControl/eQMS.
Pay: $85,898.64 - $103,447.83 per year
Work Location: In person
