Full-Time QA IT Systems Senior Specialist

PurposeThe 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

• 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.

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