Change Control Specialist

Craft business plans to independently advance change control initiatives, implementing Corrective and Preventative Actions (CAPA's) and process improvements for manufacturing operations. Assess sophisticated proposed change controls to evaluate scope, impact, risk, and regulatory implications, while reviewing and editing controlled documentation in accordance with cGMP standards. Coordinate cross-functional meetings to drive implementation and provide mentorship to teams, ensuring all activities remain GMP compliant. Independently monitor multiple concurrent projects, identifying and addressing potential obstacles timely. Present business critical change controls to senior leadership and document all training, including for new employees. Schedule is Monday-Friday, 8am-4:30pm in Rensselaer, New York.