Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 750 employees.

Job Summary

To execute defined and trained Quality Control department tests for the release of raw materials, intermediate products and final products according to defined procedures and protocols and according with best cGMP work practices, Quality Standards and metrics. As well as assisting in the implementation and maintenance of policies for Quality Control department within Valneva. Carry out laboratory tasks as identified by QC department.

Responsibilities:

  • Execute analytical procedures, for testing of raw materials, intermediate products and final products, according to defined SOPs and protocols
  • Apply best cGMP work practices and techniques to test and release raw materials and product within specification
  • Ensure that all necessary training is complete in the procedures conducted, and operate in compliance with best cGMP working practices at all times
  • Conduct on-time reporting according to the defined and trained document management standards including review and verification of analytical data
  • Immediately escalate and report any deviations to materials, facilities, processes or procedures to the Head of QC
  • Be accountable for the analytical laboratories being clean, tidy and well organised and in a state of continuous inspection readiness
  • Conduct all activities in the most careful and safe manner and in full compliance with HSE requirements
  • Ensure that at any time equipment, facilities and materials used in the QC laboratories comply with defined standards
  • Support change controls, investigations and CAPA’s in the post diligent manner
  • Identify areas for continuous improvement and escalate those to the Head of QC
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team setting
  • Maintain adequate stocks of materials and equipment and laboratory consumables
  • Assist in monitoring and maintaining calibration status of all equipment within the Quality Control department
  • Calibration of pipettes and informing relevant personnel in a timely manner of any failure of calibration
  • Arrange subcontract of QC testing and dispatch to approved suppliers and provide support to the Logistics department
  • Assist in ensuring adequate stocks of material and equipment for effective operation of laboratories
  • Storage of in process, and final products samples including, for stability and retention purposes
  • Preparation of SOPs (where applicable) in accordance with Valneva Quality systems
  • Perform filing duties and other QC administrative duties as required by the line manager or Head of QC
  • To undertake any other duties as requested by the line manager in accordance with company requirements
  • Shift work and out of hours work as required

Experience:

  • A minimum of 2 years’ experience working within a QC laboratory working to GMP within a recognised quality system
  • Writing and working to SOP documentation
  • Analytical methods experience, in a production-focused environment, in assays (not limited to) Haemagglutination assays, micro-plate assays such as ELISA and dye binding colorimetric assays (Bradford Method, Coomassie Plus), Electrophoresis, TVC and UV Spectrophotometry
  • Assay development, validation and transfer experience desirable
  • Experience of working within Quality Management Systems which include deviations, change controls and CAPA’s
  • Cell culture and Microbiological experience would be preferable
  • Plaque testing and ELISA experience highly desirable
  • Proven track record of being able to maintain the highest standards of hygiene and
    cleanliness in a laboratory environment
  • All round experience of working within a laboratory environment

Skills:

  • Capability to organise and schedule work within a busy laboratory
  • Knowledge of GMP guidelines and regulatory bodies
  • Well organised, self-motivated individual
  • Ability to follow instructions and manage workload to meet expected work schedules

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