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Furniture Sales Professional - Ashley Homestore - Chicopee MA Full Time

Akebia Therapeutics

Furniture Sales Professional - Ashley Homestore - Chicopee MA Full Time

Cambridge, MA
Paid
  • Responsibilities

    The QA Specialist, Documentation and Training role is the primary person responsible for day-to-day operations of the document control and training programs, including the document revision process, record archival, and training activities within the electronic Quality Management System. They will also support other Quality Management System initiatives as opportunities arise. The QA Specialist reports to the Senior Manager of Quality Systems in supporting all activities related to Quality Management Systems.

     

    Required Skills

    Under the guidance of the Senior Manager of Quality Systems, the candidate will:

    • Coordinate and maintain the Documentation and Training programs, to ensure patient safety, product quality, and overall compliance, within the context of a virtual sponsor/business partner environment. These responsibilities include but are not limited to:

    • Maintaining Document Control processes and systems.

      • Ensure consistency of documentation and compliance.
      • Conduct and champion documentation control programs.
      • Manage Document/Record Archive Program.
      • Maintain appropriate filing structure to keep archived material identified, secure, and easily retrievable when needed.
      • Maintain appropriate chain of custody for controlled documents submitted for archival.
      • Maintain archive database for accuracy of documentation details and location.
      • Support efforts during regulatory inspections.
      • Retrieval of documentation upon internal customer request.
      • Prepare and coordinate documentation transfer to offsite archive.
      • Support and advise end users on document system requirements and workflows.
    • Support the GxP Training Program

      • Identify issues and trends for system, procedure, and training improvements.
      • Conduct user training sessions.
      • Collaborate with document authors to develop appropriate training materials and exams.
    • Participate in quality and process improvement initiatives and project teams.

    • Identify opportunities for process and system improvement and enhancement.

    • Prepare and analyze metrics for management review and escalation of issues.

    • Evaluate questions and issues received from end users, make decision on appropriate follow-up steps based on established processes, procedures and guidelines, and escalate to management as appropriate.

    Required Experience

    Basic Qualifications:

    • Bachelor’s Degree
    • 2+ years of quality assurance related experience.

    Preferred Qualifications:

    • Proficient in Microsoft Word, including document formatting, application of styles and numbering, tracked changes and comments.
    • Comprehensive knowledge of good documentation practices and document control concepts.
    • Knowledge of quality assurance principals, best practices, and quality systems used in a manufacturing environment.
    • Demonstrated ability to coordinate process improvement initiatives and quality system related projects.
    • Knowledge of both domestic and international cGMP and other relevant regulations.
    • Demonstrated ability to interact and communicate effectively with peers, senior management, regulatory officials, auditors, contractors and consultants.

     

    Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease. The Company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com.

    Akebia Therapeutics is an equal opportunity employer and welcomes all job applicants.  All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

     

  • Qualifications

    Under the guidance of the Senior Manager of Quality Systems, the candidate will:

    • Coordinate and maintain the Documentation and Training programs, to ensure patient safety, product quality, and overall compliance, within the context of a virtual sponsor/business partner environment. These responsibilities include but are not limited to:

    • Maintaining Document Control processes and systems.

      • Ensure consistency of documentation and compliance.
      • Conduct and champion documentation control programs.
      • Manage Document/Record Archive Program.
      • Maintain appropriate filing structure to keep archived material identified, secure, and easily retrievable when needed.
      • Maintain appropriate chain of custody for controlled documents submitted for archival.
      • Maintain archive database for accuracy of documentation details and location.
      • Support efforts during regulatory inspections.
      • Retrieval of documentation upon internal customer request.
      • Prepare and coordinate documentation transfer to offsite archive.
      • Support and advise end users on document system requirements and workflows.
    • Support the GxP Training Program

      • Identify issues and trends for system, procedure, and training improvements.
      • Conduct user training sessions.
      • Collaborate with document authors to develop appropriate training materials and exams.
    • Participate in quality and process improvement initiatives and project teams.

    • Identify opportunities for process and system improvement and enhancement.

    • Prepare and analyze metrics for management review and escalation of issues.

    • Evaluate questions and issues received from end users, make decision on appropriate follow-up steps based on established processes, procedures and guidelines, and escalate to management as appropriate.

  • Industry
    Transportation / Trucking / Railroad