Hikma Pharmaceuticals USA Inc.

  • ASCEPTIC TRAINER

    Job Location US-NJ-Cherry Hill
    Posted Date 4 weeks ago(11/16/2018 5:05 PM)
    Job ID
    2018-4827
    Job Function
    Quality
  • Overview

    The Aseptic Trainer is responsible for the aseptic gowning qualification program at Cherry Hill to ensure compliance with quality and regulatory requirements for aseptic processing and to ensure the sterility of West-Ward product.  Responsible for coordination & scheduling of training activities, delivery of training and skill check evaluations.   

    Responsibilities

    1. Maintains aseptic gowning qualification training program.
    2. Coordinates annual gowning qualification program and works closely with other department supervision/management to ensure compliance with qualification due date.
    3. Coordinate, schedule and provide training materials for all training activities related to the aseptic gowning process to ensure compliance with regulatory requirements, policies and procedures, and position/employee curriculums.  This includes but is not limited to coordinating missing requirements reports, preparing paperwork to create/modify position/employee curriculums and obtaining approvals.  Identify and arrange training for “instructors” in functional work areas, etc. 
    4. Create and maintain compliance reports, etc. 
    5. Write SOPs/JAs, knowledge checks and skill check qualifications and serve as SME. 
    6. Participate in training audits as required and work closely with manufacturing and quality management to ensure that internal and regulatory audit commitments are processed in a timely manner.
    7. Participate with periodic aseptic gowning sequence evaluation.
    8. Identify and investigate deviations & exceptions related to the aseptic gowning process and evaluate/recommend corrective action. Write exception reports.
    9. Participate in functions involving teams to increase efficiency, solve problems, and improve processes.
    10. Performs all other duties as determined by supervisor and management.

    Qualifications

    Must be self-motivated, detail oriented and have strong organizational skills.  Excellent verbal and written communication skills are required to effectively communicate with all levels of personnel. Must be computer literate.  Must have strong knowledge of the gowning process required for Class 100 clean rooms and the ability to gown utilizing strict aseptic clean room gowning process.  Must have ability to effectively train others and match training technique with needs of trainee.   Ability to implement new training ideas.  Ability to flex schedule to provide training on off-shifts required.

     

    Education and/or Experience:

     

    BA/BS degree in relevant scientific field with a minimum of 5 years of relevant experience (gowning and working in cleanroom environments), or a MS degree in relevant scientific field and 1-4 years relevant experience.

     

    Physical Demands:

     

    The gowning function of the position requires frequent bending, twisting and reaching. 

     

    Work Environment:

     

    Aseptic Trainer must work in aseptic clean room areas totally gowned with mask, goggles, hood, coverall, boots and gloves. The conditions are difficult to work in.  At times environment can be confining.  The use of sanitizing agents in the clean rooms may be moderately disagreeable.

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