Manufacturing Support Specialist - Document Control
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Key details
- Location
- Cayey, PR, United States
- Work style
- Onsite
- Level
- Mid level
- Job type
- Contract
- Experience
- 2–5 yrs
- Function
- Customer success & Support
- Focus area
- other
- Posted
- 3d ago
Skills
control systemsdocument controlengineering change ordersexcelgmpleanmicrosoft officemicrosoft wordpowerpoint
About the 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
- 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.
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