QA IT Systems Senior Specialist - Remote

Overview

The Sr Specialist QA IT Systems is responsible for providing direction in quality assurance software validation activities, ensuring that defined software validation practices and procedures are being followed.

In Short

• Provide validation support to project managers.
• Ensure software quality assurance during IT projects.
• May participate as a team lead or member on validation projects.
• Manage all validation activities including protocol writing and document reviews.
• Implement Quality Control standards into departmental documents.
• Provide direction regarding software validation/QA issues.
• Act as a liaison between IT and Quality Assurance departments.
• Interface with FDA and 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.
• 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 package of benefits including paid time off.
• Medical/dental/vision insurance.
• 401(k) plan for eligible employees.
• Participation in short-term incentive programs.