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