IT Application Support Analyst - GxP/Validation-BB0827

Job Description

Job Description

IT Support Analyst (Computer System Validation/GxP) - BB0827

**CSV and Pharma/GXP experience is required.

BB0827

Miramar, FL

15+ Months

Core Skills:

1. 1+ years IT Application Support

2. Business Analysis  

3. Computer System Validation / GxP

4. Technical Documentation

5. Stakeholder & Vendor Management

6. Fluent in English and a plus if they know some Spanish

Tools

• ServiceNow
• HP ALM
• Microsoft Project
• Microsoft 365

Overview

The IT Support Analyst will support local IT applications and serve as a key connection between IT and business operations within a pharmaceutical environment. This role will help manage applications, support validation activities, translate business needs into practical technical solutions, and collaborate with local and global teams to improve efficiency while meeting quality and regulatory requirements.

Responsibilities

1.    Application Support and Validation:

·         Analyze business needs and validate proposed solutions with business users and IT teams.

·         Collaborate with business users, IT colleagues, and stakeholders to support existing processes and technologies in the R&D business area.

·         Identify business requirements, review business processes, and assess the impact on application delivery.

·         Develop, coordinate, and support test plans for business and functional processes during SDLC testing.

·         Coordinate with business units to support project planning and timelines.

2.    Technical Management:

·         Work with internal and cross-functional IT teams to support system configuration, integrations, and interfaces with instruments or other systems.

·         Prepare technical and validation documentation to support system compliance.

·         Document user and business needs and translate them into clear system requirements and specifications.

·         Provide ongoing end-user support, troubleshoot issues, and respond to system-related questions.

3.    Stakeholder Communication:

·         Serve as a liaison with internal technical teams and external vendors to manage and resolve technical issues.

·         Provide routine status updates and prepare clear reports for business and IT stakeholders.

Qualifications

·         Bachelor’s degree in computer science, engineering, information technology, or a related field.

·         Minimum of 3 years of experience in IT application support and business analysis, preferably in clinical research or the pharmaceutical industry.

·         Strong understanding of the software development life cycle, validation methodologies, and business analysis practices.

·         Experience with IT business analysis and support tools such as HP ALM, ServiceNow, Microsoft Project, and Microsoft 365.

·         Knowledge of 21 CFR Part 11 and GxP guidelines.

·         Experience working in a global environment, with fluency in English. Bilingual ability, preferably English and Spanish, is a plus.

TechData is now a part of Quantive Intelligence, same people, expanded capabilities and we are proud to be an equal opportunity workplace and an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Company Description