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 for existing applications.
• Ensure software quality assurance during IT projects.
• Manage validation activities including protocol writing and document review.
• Implement Quality Control standards in departmental documents.
• Provide direction on software validation/QA issues.
• Act as a liaison between IT and 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.
• Technical experience in Chemistry, Pharmacy, Microbiology, Engineering, or Computer Science.
• Two years combined experience in software development and software testing desired.
• ASQ certification in Software Quality Engineering desired.

Benefits

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