Quality Assurance Specialist

The Quality Assurance Specialist works in a Good Clinical Practices compliant setting as part of a global team, assessing quality compliance and ensuring that appropriate processes are followed. Work as directed within a Quality Assurance team to support project needs specified by a relevant project lead. Maintain the integrity of all data. Lead development of specific project elements with minimum supervision. Depending on project requirements, collect necessary data for projects, perform analytical activities, draft sections of reports or presentations for assigned projects. Provide regular progress reports and ensures deadlines are met. Routinely participate in project/client meetings. Ensure company core operating procedures are understood and implemented. Keep abreast of emerging trends, tools, and technologies. Other duties as assigned. Education Bachelor's degree in life or computer sciences or other related discipline. Experience in a quality environment may be considered in lieu of aforementioned bachelor's degree disciplines. Experience 3 to 5 years in a clinical research quality environment or other relevant experience. Skills Analytical thinking and troubleshooting skills. Complex problem-solving skills. Ability to multitask and efficiently manage time. Possess a strong working knowledge of Good Clinical Practice ICH guidelines software validation requirements 21 CFR Part 11, Annex 11 and other applicable regulations Excellent verbal and written communication skills. Must be detail oriented. Proficient in the Microsoft office suite. Knowledge of Trackwise Digital is a plus. Cytel Inc. is an Equal Employment / Aff… Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law. J-18808-Ljbffr