Oxford Immunotec, Inc.

  • Quality Assurance Technician

    Job Locations UK-Milton Park, Abindgon
    Posted Date 2 weeks ago(11/05/2018 12:49 PM)
    ID
    2018-1908
    # of Openings
    1
    Department
    Quality & Regulatory
  • Overview

    This position supports the Quality team in the QA review of raw material testing, Document control using electronic QMS system (EtQ), control of equipment records, the QC of the ODL testing service results and general administration of documentation for the QMS. This will include the following

    Primary Responsibilities

    Overall responsibilities:

    1. To assist with the QC of raw materials used for manufacturing and QC.

    o    Incoming QC of items requiring CofA/packaging checks

    1. Perform document control activities using electronic QMS (EtQ)
    2. Assist the Equipment team in scheduling equipment due for calibration and carry out QA review of equipment certificates
    3. Aiding the validation of procedures, processes and equipment

    o    Carry out testing where required following a planned procedure

    1. QA review of completed logs, forms and monitoring data

    o    Temperature logger data, receipt of goods, other forms

    o    Aiding with the completion of risk assessments, e.g. for out of specification equipment

    1. Assisting with the control of Quality Management system documentation

    o    Issuing of manufacturing documents and labels

    o    Scanning of Quality documents

    o    Auditing QC records

    1. To assist with the QC of results from the ODL testing service
    2. Assisting with the monitoring of compliance with the QMS and with tracking systems associated with ISO 13485:2016 and ISO 17025:2005 and the QSR

    o    Reviewing staff training records

    1. Assist the Senior Quality Manager to ensure the continuing effectiveness of the QMS
    2. Assist during internal and external audits as required
    3. Perform miscellaneous duties as necessary

     

    Specific deliverables for the role are:

    1. Contributing towards the maintenance of the quality of OI products in fulfillment of OI’s Company goals.
    2. Monitoring of product conformity through incoming QC, archive kit and stability testing
    3. Assisting with ensuring compliance in the manufacturing process and documentation
    4. Ensure that areas of responsibility do not contribute to any major non-conformance during external audits for GMP, ISO 13485:2016and ISO 9001:2008.
    5. Working to Oxford Immunotec’s Company Values at all times.

    Qualifications

    Technical skills and abilities

    • Educated to degree level in a relevant scientific subject or with relevant technical/practical experience
    • General use of computers with MS programs and the InternetEmotional skills and abilities
    •  
    • Pleasant disposition with a co-operative attitude
    • Energetic and enthusiastic
    • Attention to detail and Quality ‘mindset’
    • High standard of numeracy and literacy
    • Conscientious
    • Able to work under pressure
    • Work well alone and as part of a team

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