QA IT Systems Senior Specialist (Remote)

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Purpose

The Sr Specialist QA IT Systems is responsible for providing direction in quality assurance software validation activities including: reviewing software requirement documents; writing and reviewing validation documents; executing and reviewing validation test cases; and updating departmental procedures. This position ensures that defined software validation practices and procedures are being followed.

Responsibilities

• Provide validation support to project managers regarding activities supporting existing applications of all phases of the System Development Life Cycle process.
• Ensure software quality assurance is achieved during IT projects while meeting project objectives and deliverables; review validation deliverables to ensure consistency with defined practices and procedures.
• May participate as a team lead or team member on validation projects.
• Manage all validation activities such as protocol writing, review of validation documents, storage of controlled documents and resolution to problem reports.
• Responsible for implementing Quality Control standards into departmental documents and ensuring all departmental training is complete.
• Provide direction to clients and software engineers regarding software validation/QA issues.
• Act as a liaison between IT department and other Quality Assurance departments.
• Interface directly with FDA and other regulatory agencies during audits.
• Must complete project tasks within time and budget constraints.

Qualifications

• Bachelor’s Degree in Science, Engineering or applicable discipline.
• 5+ years’ experience in validation, systems testing, IT implementation, qualit