• Documentation Training Specialist

    Job Locations US-CA-Santa Ana
    Posted Date 1 month ago(2/25/2019 3:21 PM)
    Requisition ID
    General Administrative/Clerical
    Company (Portal Searching)
    FUJIFILM Holdings America Corporation
  • Overview

    Irvine Scientific, a member of Fujifilm Holdings Corporation, is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in cell therapy and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 45 years, Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services. Additional information can be found at www.irvinesci.com.


    We are hiring for a Documentation Training Specialist (internally known as Training Coordinator)  As the Training Coordinator you will coordinate and conduct SOP, ISO 13485, & GMP training for new employees and on an on-going basis. Review training requirements for jobs and establish training requirements and proficiency standards. Track and trend human errors for re-training needs and SOP and process improvement needs. Maintain training database up to date. Ensure quality is present in all employee training functions that impact quality and are regulated by GMP, 21 CFR 820, ISO 13485, MDD 93/42/EEC, IVDD 98/79/EC, Canadian Medical Device Regulation.




    External US


    • Incorporate corporate culture & OPEX program into new hire training program
    • Set minimum ISO/GMP training requirements for all jobs
    • Coordinate and conduct onboarding ISO/GMP training & ensure that procedural proficiency has been achieved and all training documentation filed with HR and Document Control as appropriate
    • Track and trend human errors for re-training needs and SOP and process improvement needs.
    • Coordinate re-training with department management & HR as needed, including removing an employee temporarily from their job until proficiency is achieved.
    • Maintain training database up to date including individual training records and training plans for each job.

    Experience/ Education:

    • A minimum of two (2) years’ experience working in a training environment and with an electronic training tracking/learning management system.
    • A minimum of six (6) years’ experience working in a medical device manufacturing environment
    • Manufacturing and/or Quality experience, preferably both 
    • Bachelor’s degree preferred.
    • High school diploma or equivalent.
    • Extensive knowledge of current industry regulations, e.g., cGMP, 21 CFR 820, ISO 13485, Canadian Medical Device Regulations, and quality management systems
    • Working knowledge of problem solving tools and root cause analysis
    • Working knowledge of electronic training tracking/learning management system
    • Excellent interpersonal and communication skills
    • Excellent English verbal and written communication skills

    Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.


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