Immunomedics, Inc.

  • Senior LMS Administrator

    Job Locations US-NJ-Morris Plains
    Posted Date 1 month ago(4/17/2019 2:57 PM)
    Job ID
    2019-1436
    # of Openings
    1
    Category
    Quality
  • Overview

    Manage GMP Training Program, company-wide, and assure that company-wide GMP training is performed in compliance with Current Good Manufacturing Practices, company policies and procedures.

    Oversee Administration of the ComplianceWire Learning Management System (LMS) including workflows for user access/ security roles, assignments/ curriculums / user groups, SOP revisions, data entry/ organization, custom fields

    Responsibilities

    • Manage LMS.
    • Oversee management and act as subject matter expert of company’s electronic Learning Management System (ComplianceWire)
      • Maintain and archive paper and electronic files associated with training.
      • Train users manage users and security roles.
      • Audit data entry users for accuracy. Audit integrity of system.
      • Support audits (internal, external) to verify regulatory and quality requirements have been met.
      • Support inspection readiness: plan and interact with regulatory agencies during inspections on training-related matters and prepare training-related records.
    •  Enhance, develop and deliver content for Systems Training.
      • Maintain a Training Master Plan.
      • Ensure proper training documents (e.g., job curricula, instructor-led courses, Knowledge and Performance Assessments, job aids, etc.) exist to support all gap operations. Maintain applicable Training Policies and/or SOPs.
      • Support the set-up of training classes and capture attendance.
      • Maintain the Site Core and Quality Systems Curriculum.
    • Collaborate with managers to establish curricula requirements for new and existing employees.
      • Ensure annual curricula reviews are performed by Functional Group Managers.
    • Remain current with best practices in regulatory training, adult learning principles and styles, and technology that enables training solutions.
    • Carry out direct supervisory responsibilities in accordance with the department-set goals.   Responsibilities include interviewing and onboarding; employee training and development; planning, assigning, and directing work; appraising performance; rewarding and disciplining; and corrective action and complaint resolution.

    Qualifications

    • Bachelor degree is required, with at least 3-5 years of experience in the biotechnology, pharmaceutical, or clinical (GxP) industry; or equivalent combination of education and experience.
    • Minimum of 2 years’ experience working in design, development, and delivery of training
    • Experience working in a regulated environment with strong knowledge of ICH/GxP and regulatory requirements.
    • Self-motivated, with the ability to work effectively in a dynamic and diverse environment.
    • Demonstrated ability to interface effectively with senior leadership and all levels of the organization.
    • Excellent problem-solving, written, and verbal communication skills.
    • Ability to effectively manage priorities under strict and dynamic deadlines.
    • Experience with electronic Learning Management Systems (eLMS) and Document Management Systems (eDMS).

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