About AbbVie AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 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 Qualifications: •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. •Two years combined experience in software development and software testing desired, but not required. •ASQ certification in Software Quality Engineering desired, but not required. Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.