The Quality Assurance Test Analyst will be an integral member of the Quality department and will provide direct support in the management, maintenance, and continuous improvement of Monogram's Quality Management System (QMS).
Responsibilities
Management and maintenance of the IT Change Control System.
Effective management of validation activities between cross-functional groups such as IT, user and business process owners, consultants, and Quality.
Design and preparation of test plans and test cases in collaboration with IT and user groups including key stakeholders and SMEs.
Requirements/Qualifications
BS/BA in Information Technology/Computer Science, Biological or Clinical Laboratory or other related disciplines
4-6 years of experience with performing computer validations or related assignments.
Previous experience in a regulated environment, preferably in Part 820 QSR, ISO 13485, GxP or CAP/CLIA. Ability to interact effectively with various departments: Research, Process Development, Support Operations, Customer Service, MCRL, IT, and Clinical Research.
EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Understands and articulates the business case of business questions and the estimated value being delivered. Designs dashboards and analyses to be performed, and appropriate visualization and analytics tools to use. Identifies trends and patterns to address identified business questions and provide insights through reporting and data visualization techniques. Works with other data and analytics professionals to optimize, refine, automate and scale analysis into repeatable analytics solutions and decision support tools.