Manufacturing Support Specialist - Document Control
Posted
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.