SQA - FDA

BA/BS degree in Computer Science/MIS or in a scientific field. Must have experience beyond software testing with emphasis on executing and improving IT quality system. Must have an in-depth understanding of GLP, GAMP, and other guidelines that relate to EPA and FDA regulations for electronic systems and data. Three to six years experience as a QA specialist is required. Must be able to create validation requirements and implementation plans from beginning to end of project. Must have detailed knowledge of the software development life cycle. Must be resourceful and a flexible self starter, capable of producing quality work with minimal supervision. Must be able to manage multiple priorities and demonstrate the ability to work with diverse groups of people. Must possess excellent verbal and written communications skills that facilitate issue resolution and conflict management. Must be a demonstrated team player. Must have a working knowledge of document management systems. Experience with creating and delivering course materials for training sessions is also required.
REQUIREMENTS
Comments: This is a QA position, not a tester position. Ideal candidate will have IT process experience and understand the software development lifecycle. A solid background in IT QA Auditing and process development is desired. Main responsibilities: The IT Quality Assurance Specialist will execute and improve quality processes for Regulatory IT solutions. The individual will work closely with various IT teams, the business community, and other Quality Assurance groups to execute and improve quality processes, compliance strategies, and necessary documentation required to support EPA and FDA regulatory requirements. Activities will also include assessment of current IT systems and development and implementation of validation requirements for new and legacy systems. The main responsibility of this person will be to implement the validation strategies for IT systems being developed to meet regulatory compliance needs. This will require extensive development and updates for SOPs, system requirements, reports and other documents related to regulatory guidelines and procedures. This individual will be responsible for mentoring and training project team personnel on necessary EPA and FDA guidelines as they apply to information technology systems. They will conduct reviews and audits of IT processes to ensure IT is executing against relevant SOPs, and provide corrective/preventative action recommendations. Additional responsibilities will include managing change requests of IT systems and training records of IT personnel, ensuring compliance to quality standards.