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QC Associate Specialist

28/07/2020
- Niel

Company information
Job content

The QC Associate Specialist assists in the different aspects of the method lifecycle within QC and ensures the intended use of the method throughout the product lifecycle. He/she is a hands-on person responsible for the performance of lab activities in the QC lab and assures that the commitments are delivered in due time, in line with business requirements and priorities, in compliance with the current international and Belgian laws, regulations and guidelines in general, as well as cGMP guidelines and the company’s internal standards and procedures.  

The QC Associate Specialist’s duties shall include, but not be limited to:

  • Primary responsibility will be assisting in the development, qualification and implementation of new techniques at QC, eg. protein determination by fluorescence, dsRNA slot Blot, Western Blot, ELISA, DNase/RNase detection method, Flow Cytometry…
  • Perform, a variety of routine, specialized laboratory operations and QC development activities in the quality control of mRNA based pharmaceutical drug substances and products according to cGMP requirements and to current procedures and protocols with the aim of compliance to cGMP requirements.
  • Perform, report and follow up of
  • QC IPC and release testing
  • QC Stability program (long term, accelerated stability and in-use)
  • Qualifications of reagents – incoming QC
  • Environmental monitoring
  • Document and report data and results in accordance with the current procedures and GMP requirements
  • Maintain the QC area according to the procedures and instructions
  • Perform routinely check of the installations, equipment and premises
  • Perform on regular intervals routine maintenance, calibration, qualification activities
  • Warn the QC Manager in case of problems, analyze the data, help in trouble-shooting and propose technical solutions
  • Perform failure investigations
  • Assist in the technology transfer from product development.
  • Execute validations of methods according to protocols
  • Draft QC instructions, forms and protocols
  • Responsible for the logistics regarding:
  • Reagents and consumable inventory management
  • QC sample inventory management & outsourced activities
  • Data Management
  • Equipment maintenance
Profile
  • Master in biology, (bio)medicine or life sciences or related field or equivalent relevant laboratory experience.
  • Minimum of two years of relevant laboratory experience (can be both academic or industrial) in the field of immunology and molecular biology
  • Broad technical expertise and mastering of several laboratory techniques like spectrophotometry, ELISA, Western blot, Dot blot, Flow Cytometry, RNA/DNA capillary gel electrophoresis and sequencing.
  • Working knowledge of good manufacturing practices (GMP) and/or lab quality assurance practices is a plus
  • Good understanding of the method lifecycle process and its relation to the product lifecycle.
  • Detail-oriented and accurate in following instructions, record keeping and completion of reports
  • Affinity with GMP guidelines and working in a quality-oriented environment
  • Able to perform experimental trouble-shooting and propose technical solutions
  • Good organizational capacities and detailed documentation practices
  • Good knowledge of English
  • Knowledge of the following software tools are considered a plus; Softmax Pro, 2100 Bioanalyzer Expert
What do we offer?

We offer you an exciting job in a dynamic and entrepreneurial environment with room for personal development

Contact

For more information, call Laura Schollen 04 94 04 21 32