Pharma LIMS & Quality Systems Analyst - GxP & Validation

ProPharma; Raleigh (NC); Hybrid; USD 90,000 - 120,000; Full time

Job summary

ProPharma seeks a Sr. Business Analyst to support global Quality & Compliance. You will align requirements gathering, laboratory systems, and QA within a GxP framework, focusing on design specifications and verification for LabVantage LIMS.

You’ll collaborate with developers, stakeholders, and client teams to ensure clean Data Packets, complete documentation, and compliant system verification across multiple workstreams.

Qualifications

• Bachelor’s degree required; Life Sciences, CS, or Information Systems preferred.
• 3–7 years in pharmaceutical, biotech, lab, quality, validation, or regulated systems.
• Experience with LIMS platforms; LabVantage preferred.
• Familiarity with regulated tools like Veeva, Tableau, ELN, LES/MES, eQMS.
• Experience gathering, analyzing, and documenting business or system requirements.
• Experience with software testing, system verification, validation, or QA in regulated env.

Responsibilities

• Research and assemble Data Packets supporting system design and configuration.
• Analyze requirements and source documentation for completeness and accuracy.
• Support development of Design Specifications in a structured, traceable manner.
• Verify LabVantage LIMS configurations against approved Design Specifications.
• Collaborate with developers, configuration specialists, and client stakeholders to resolve findings.
• Maintain high-quality documentation in compliance with GxP and validation standards.
• Proactively communicate with stakeholders to drive clarity and timely issue resolution.

Skills

Requirements analysis

Quality & compliance mindset

Regulated environments

Analytical thinking

Stakeholder communication

Education

Bachelor's degree

Life Sciences or related field

Tools

LabVantage LIMS

Veeva

Tableau

ELN/LES/MES

Job description

ProPharma seeks a Sr. Business Analyst to support global Quality & Compliance. You will align requirements gathering, laboratory systems, and QA within a GxP framework, focusing on design specifications and verification for LabVantage LIMS.

You’ll collaborate with developers, stakeholders, and client teams to ensure clean Data Packets, complete documentation, and compliant system verification across multiple workstreams.