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Manufacturing Support Specialist - Document Control

QRC Group

  • Cayey, Puerto Rico
  • 27 days ago

    Highlights

    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. Ensure documentation updates related to Capital Projects, Validation activities, Quality Notifications, and CAPAs are completed on time.

    Numbers & Facts

    LocationCayey, Puerto Rico
    Websitehttps://qrcgroup.com/

    Description

    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.
    • Experience with bulk certifications
    • 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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