QA IT Systems Senior Specialist

Summary

Join AbbVie as a Sr Specialist QA IT Systems and provide 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. Ensure software quality assurance is achieved during IT projects while meeting project objectives and deliverables. Manage all validation activities such as protocol writing, review of validation documents, and resolution to problem reports. Provide direction to clients and software engineers regarding software validation/QA issues and act as a liaison between the IT department and other Quality Assurance departments. Interface directly with the 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, IT implementation, quality assurance or software quality engineering in a regulated healthcare industry
• Technical experience in as many of the following areas as possible: Chemistry, Pharmacy, Microbiology, Engineering and Computer Science. This should include a thorough technical knowledge of various aspects of the business including Quality Control/Assurance, GMP regulations, and new product development

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

Preferred Qualifications

• Two years combined experience in software development and software testing desired, but not required
• ASQ certification in Software Quality Engineering desired, but not required

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs