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Manufacturing Support Specialist Document Control
Job Location:
Job Location:
Juncos - Puerto Rico
Monthly Salary:
Not provided by the employer
Monthly Salary:
Experience Required:
4years
Experience Required:
Posted:
15 October 2026 (4 days ago)
Posted:
Application Deadline:
12 January 2027
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
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.
