Compliance Team, Inc.

  • Technical Writer/ Project Manager

    Job Locations US-MO-St. Louis
    Posted Date 3 weeks ago(6/28/2018 11:35 AM)
    ID
    2018-1236
    # of Openings
    2
    Category
    Management
  • Overview

    Compliance Team, Inc. is a leading provider of technical consulting services to our clients in the pharmaceutical, biotechnology, and medical device industries in the areas of commissioning, qualification, validation and regulatory compliance.  We are proud of our talented professionals and the major contributions they make to our clients’ successes on mission critical projects. 

     

     

    We are seeking One mid-level and one senior Technical Writer/Project Manager to write, edit and manage multiple technical writing projects simultaneously. Will not manage people, just writing projects.

     

     

    Responsibilities

    • Manage document development, review, approval, and implementation for the NHSD Document Optimization Project.  Ensure project deliverables are completed per the project timeline.
    • Review and analyze existing procedures for concurrence with correct department methods through direct observation of aseptic manufacturing processes and interviews with subject matter experts.
    • Draft new and revised SOPs, Batch Records, Forms, and OJT skill assessment documents. 
    • Write standard operating procedures with appropriate details that are easily understood, readily usable for consistency in training, and conform to company policies and government regulations.
    • Review the impact of the proposed changes with regard to other support documents.
    • Interact with internal departments to develop new and revised documents.  Directly interact with the sites' Manufacturing, Quality, Validation, Regulatory and EHS Departments to ensure document revisions are accurate, executable and comprehendible.
    • Track and report document status.

     

    Qualifications

     

    • Knowledge of Quality Systems as it relates to GMP documentation requirements
    • Strong technical writing ability with experience writing instructional documents.
    • Understanding of aseptic and packaging/inspection operations
    • Project management and organizational skills
    • Excellent verbal and written communication skills
    • Interpersonal and communication skills required to build and maintain working partnerships with all levels of the organization
    • Strong technical writing ability.
    • Intermediate to advanced computer skills that include MS Word, Visio, PowerPoint, and Excel. 
    • Excellent project management and organizational skills including the ability to independently understand, follow, and implement complex instructions and follow assignments through to completion.

     

     

    The successful candidate should demonstrate integrity, reliability, dedication, adaptability, innovation, and self-motivation.

     

     

     

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