Operator QC Biologicals

  • Full-time

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 55,000 staff across a network of more than 1000 independent companies in over 50 countries and operating more than 900 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.  

In 2020, Eurofins generated total revenues of EUR € 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.

Eurofins CDMO is one of the leading CDMOs in Europe providing high-quality, customized drug development solutions for specialty and biopharma clients. Our focus is to support clients on the earliest phases of their development pathway (from API to the clinical packaging).
Its Belgian subsidiary, Eurofins Amatsigroup NV, is based in Ghent, offering a complete drug development package for new drug entities (biological and chemical) up to early clinical phases to third parties to help them in speeding up the development and manufacturing of their drugs.

Job Description

You will be part of an analytical Quality Control (QC) team responsible for performing activities in support of manufacturing and release of biologicals taking into account the regulatory requirements and clients’ needs. You will report to the QC Manager of the DS Biologicals team.

Main responsibilities:

  • IQC of (raw) materials used in the GMP unit:
    • Create specification sheets of the (raw) materials (SSOM) including the incoming QC requirements and testing to be performed on the raw materials and critical goods used in the manufacturing processes and in the QC tests.
    • Perform IQC and ensure external IQC testing is organized.
    • Ensure sampling and testing is performed.
    • Fill out data on the specification sheet of materials (SSOM).
    • Evaluate test results and supportive information.
  • QC of buffers:
    • Perform bioburden and endotoxin testing on buffers in a cGMP environment according to the applicable requirements as described in the standard operating procedures.
    • Document the work performed in lab notebooks and/or in QC records according to GDP guidelines.
  • QC testing of IPC samples and environmental monitoring:
    • Perform testing on IPC samples (HVAC, water system) in a cGMP environment according to the applicable requirements as described in the standard operating procedures.
    • Follow up and read out of the results of settle plates and contact plates of the environmental monitoring.

Qualifications

  • A bachelor degree preferably in life science, chemistry or pharmacy or other related degree.
  • Knowledge of analytical methods and microbiology is a plus (e.g. bioburden testing, endotoxin testing, UV spectroscopy, SDS-PAGE electrophoresis, Western blotting).
  • Enthusiastic, pro-active, analytical, open-minded, curious, self-motivated and hands-on approach.
  • Flexible attitude.
  • Sense for initiative, quality, accuracy and detail.
  • Be a good communicator within the team.
  • Ability to work independently as well as a member of a team in a dynamic environment.
  • Ability to plan own activities based on weekly input from the Team Leader.
  • Fluent in Dutch and English, written and spoken.

Additional Information

  • Work in a fast growing organization.
  • A position with responsibility within a dynamic company.
  • Personal development through learning on the job and additional external trainings.
  • A market oriented compensation.
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