• LFB USA - QA Training Specialist

    Job Locations US-MA-Framingham
    Job ID
    2018-1340
    # of Openings
    1
    Category
    Quality Assurance/Quality Control
    Type
    Full Time
    Company
    LFB USA
  • Overview

    Through collaboration with Manufacturing, Quality Control, Clinical Affairs, Facilities, and other operational departments, maintains the company's training system, including creation and maintenance of role based curricula, optimization of the competency based on-the-job-training, and authoring/revising associated documentation.

    Responsibilities

    • Ensures Quality Training System practices are in compliance with industry standards, current Good Manufacturing Practices (cGMP), domestic and international regulations and corporate requirements.  
    • Based on existing training plans works with the individual departments to develop role based curricula which meet the needs for GxP compliance. Implements and maintains the role based curricula in the electronic Training System.
    • Maintains paper and electronic employee training files and provides training on the Training System, as needed. Ensures training related documentation meets the applicable good documentation practice requirements.
    • Collaborates with Manufacturing, Quality Control, Clinical Affairs, Facilities, and other operational departments to define on-the-job-training needs and develops plans for ensuring a harmonized and appropriate approach throughout the individual GMP and non-GMP functions.
    • Ensures a good level of training compliance and performs training related trending for reporting of KPIs. May also support gathering and compilation of other KPI trending related data.
    • Ensures internal training documentation, such as SOPs, work instructions, etc., is created or revised to meet company and regulatory requirements.
    • Ensures mandatory training, such as GMP, GCP, Pharmacovigilance, etc., is provided to meet regulatory expectations. Develops training materials and provides training.
    • Stays current on cGMP and other training related industry trends and optimizes the Training System, in an effort to maintain and improve LFB USA’s compliance with industry standards.
    • Performs assessments of the Training System and develops/authors the strategic annual training plan.
    • Supports validation efforts related to upgrades of the electronic Training System and other electronic systems.
    • Supports regulatory inspections and client/internal audits. Is the subject matter expert for training related issues.
    • Other QA duties as assigned.

    Qualifications

    • BS degree and 6 years’ experience in a cGMP regulated environment (pharmaceutical, biotechnology, etc.) with at least 3+ years in training management.
    • Requires knowledge and understanding of GXP training requirements.
    • This position will be required to set up, execute and maintain an optimized electronic Training System.
    • Must have hands-on experience in setting up and managing training in an electronic training management system and with ability to transfer the existing knowledge into the LFB USA training management system (SmartSolve).
    • The ability to effectively present information and communicate clearly verbally and in writing.
    • Strong attention to detail is required.

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