QA IT Systems Senior Specialist (Remote)
Job title: QA IT Systems Senior Specialist (Remote) in Illinois at AbbVie
Company: AbbVie
Job description: Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on , , , , and .Job DescriptionPurposeThe 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.
- 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.
Expected salary:
Location: Illinois
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