Manufacturing Support Specialist to support manufacturing operations by managing controlled documentation, coordinating Engineering Change Orders (ECOs), and assisting with continuous improvement initiatives in a highly regulated FDA and ISO environment. Key Responsibilities • Support manufacturing areas with the implementation of document changes through Engineering Change Order (ECO) systems. • Ensure documentation updates related to Capital Projects, Validation activities, Quality Notifications, and CAPAs are completed on time. • Create, format, revise, and maintain SOPs, manufacturing batch records, and other GMP-required documentation. • Assist in manufacturing data collection, reporting, and performance metrics tracking. • Participate in Continuous Improvement (CI) and Lean Manufacturing initiatives. • Support document control activities, including deviation records and periodic document reviews. • Promote compliance with regulatory, quality, environmental health, and safety requirements. • Identify opportunities to improve product quality, process efficiency, and manufacturing performance. Requirements Education & Experience • Associate Degree or equivalent required. • Minimum of 2 years of experience working with documentation control systems in an FDA and ISO regulated environment. Knowledge & Skills • Experience with Documentation Control Systems. • Strong attention to detail and accuracy. • Excellent organizational, planning, and time-management skills. • Effective written and verbal communication skills. • Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). • Ability to work independently with minimal supervision. • Fully bilingual in English and Spanish.