Job Properties
  • Job Type
    Full-time Position
  • Background
    Biotech and Agricultural
    Engineering
    Management & Business Others
    Medical and Healthcare
    Other Science and Tech
    Others
  • Languages
    English
  • Experience Required
    Entry
  • Degree Required
    Bachelor
    • Province
      Lelystad
    • Date Posted
      October 03,2020
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    Quality Specialist II

    Job Title: Quality Specialist II

    Reports to: Manager, QA/QC

    Group / Division: LSG

    Career Band: 5

    Job Family: Quality Assurance

    Position Location: Lelystad, Netherlands

    Number of Direct Reports: 0

    Position Summary:

    Thermo Fisher Scientific Lelystad is the Center of Excellence for the production of Animal Health products. You will interact with varying levels of staff within the organization as well as with customers and regulatory agencies. You will be accountable for interactions that enhance the QA reputation and set the example for others to follow. You will demonstrate role model leadership behaviors and will be responsible for making decisions regarding compliance of processes used to make product and to maintain the controlled environment. The Quality Specialist II provides focus for the Global Quality Management System (QMS) and working closely with manufacturing and other departments to promote consistency, continuous improvement and compliance with Global/Site quality and business requirements.

    Key Responsibilities:

    • Empower staff; cultivating relationships; putting staff in a position to succeed, achieving organizational goals;
    • Supports the manager coordinates Quality Assurance (QA) activities and programs such as auditing, record review, final product functions, complaints, document management, oversight of quality systems and/or investigations within QA.
    • Complies with all job-related safety and other training requirements. Works in a safe and responsible manner in order to create an injury-free and incident-free workplace.
    • Support staff who perform quality and manufacturing audits, record review, final product release functions, complaints, validation and/or investigations at the site, and quality oversight of facilities, equipment, systems, manufacturing and laboratories at the Site.
    • Ensures quality of methods, processes, materials and products by providing coordination and review of group operations, staff training, and the assessment/improvement of systems and processes.
    • Conducts risk assessments and take appropriate actions during quality system management and oversight activities (e.g. during review/approval) to ensure adequate controls in relation to the level of product quality, safety and business risks.
    • Assist in coordinating approaches and planning for customer /notified body/corporate audits.
    • Practise excellent customer service whilst supporting the timely resolution of complaints.
    • Take an active role in the customer notification process ensuring change notification is effectively managed and customer needs are always considered.
    • Train others, to the appropriate level in an operation, and update training records.
    • Utilise the Agile system to maintain process procedures as well as SOP's to ensure that all work instructions are current and accurate.
    • Work with the QA team to focusing on improvement projects to improve product quality e.g. complaint reduction or yield/process improvements.

    Frequent Contacts:

    Internal

    • Manufacturing, Quality Control, Manufacturing Sciences

    External

    • Customers, Vendors and Certification Bodies.

    Minimum Requirements/Qualifications:

    • HBO education level
    • Fluent in Dutch and English (written and verbal)
    • Knowledge of ISO 9001, USDA and GMP/GLP.
    • Experience of CAPA/Change Control processes & problem solving
    • Excellent communication and report writing skills.
    • Ability to recognise deviation from requirements and understanding risks when decision making.
    • Experience of office packages and general computer skills.
    • Ability to challenge existing approaches to compliance in order to seek improved ways of working.
    • Ability to follow written and verbal instructions, meet targets and complete necessary paperwork.
    • Experience in investigation writing along with root cause analysis tools utilized in deviation investigations
     
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