Manufacturing Support Specialist - Document Control

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.