Oxford Immunotec, Inc.

  • Document Control Specialist

    Job Location US-MA-Norwood
    Posted Date 2 weeks ago(6/5/2018 4:22 PM)
    ID
    2018-1919
    # of Openings
    1
    Department
    QA/QC
  • Overview

    Under some supervision, manages document control and records management activities to ensure procedures are available for use and records are maintained appropriately.   

    Responsibilities

    • Support the organization in assuring policies and procedures are available to the staff who perform laboratory testing, manufacturing, research, and supporting activities.
    • Ensure compliance with document control regulations as set forth by FDA, CLIA, CAP, ISO, and state standards.
    • Provide oversight to document owners regarding document change requests and periodic document reviews.
    • Utilize an electronic Quality Management System (Q-Pulse, EtQ) and MS Office applications for maintenance of controlled documents and providing monitoring reports.
    • Ensure all locations of hard-copy procedures and forms are kept current and up-to-date following document changes.
    • Assist document developers in the creation and correct formatting of procedures, validation documents, study protocols and reports.
    • Activate documents and distribute them to the necessary individuals.
    • Prepare, maintain, analyze, and present metrics related to the document control system.
    • Assist operational departments with managing long term storage of records, including preparing records for off-site storage.
    • Assist the Quality Department with oversight of quality systems including non-conformances, audits, and inspections.
    • Communicate effectively with internal personnel as well as external auditors.
    • Collaborate effectively and positively within department and all other company departments.
    • Represent department and the organization favorably and in accordance with established Company standards.
    • Follow all company safety policies & other safety precautions within work area
    • Regular attendance and timeliness is essential

    Qualifications

    • Bachelor’s degree preferred in life sciences and 1-5 years’ experience in a regulated environment or commensurate experience.
    • 1-5 years’ Quality or Document Control experience in a laboratory or FDA-regulated manufacturing facility (medical device, biologics, or pharmaceuticals)
    • Good working knowledge of MS programs
    • Strong attention to detail and Quality commitment
    • Self-directed

     

    PHYSICAL DEMANDS: 

    The physical demands described within the Position Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to be independently mobile.  The employee is also required to interact with a computer, and communicate with peers and co-workers.  Minimal travel required including international travel. 

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