QA IT Systems Senior Specialist - Remote

Overview

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.

In Short

• Provide validation support to project managers regarding activities supporting existing applications.
• Ensure software quality assurance during IT projects while meeting project objectives.
• Participate as a team lead or member on validation projects.
• Manage all validation activities including protocol writing and document review.
• Implement Quality Control standards into departmental documents.
• Provide direction to clients and software engineers on validation/QA issues.
• Act as a liaison between IT and other Quality Assurance departments.
• Interface with FDA and other regulatory agencies during audits.
• Complete project tasks within time and budget constraints.

Requirements

• Bachelor’s Degree in Science, Engineering, or applicable discipline.
• 5+ years’ experience in validation, systems testing, or quality assurance in a regulated healthcare industry.
• Technical experience in Chemistry, Pharmacy, Microbiology, Engineering, and Computer Science.
• Two years combined experience in software development and testing desired.
• ASQ certification in Software Quality Engineering desired.

Benefits

• Comprehensive benefits package including paid time off.
• Medical/dental/vision insurance.
• 401(k) for eligible employees.
• Participation in short-term incentive programs.