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.

Summary

Co-ordination of QC sample management, including shipments and supporting QC activities, in accordance with defined procedures, protocols and regulatory guidelines.

Responsibilities

  • Shipment of QC samples and materials, including viral samples, to approved external test houses according to defined procedures, schedules and in compliance with GMP and Dangerous Goods regulations including the preparation of shipment documentation and samples
  • Embrace a flexible way of working and respond efficiently to changes to the shipment schedule
  • Support co-ordination of the storage of QC samples including maintenance of inventory logs, execution of routine stock checks and discard of applicable materials
  • Support QC activities in line with manufacturing schedule as per QC rota. QC activities include sample receipt from Manufacturing and sample storage, calibration of balances, checking of labels, documentation review and occasional coverage of Total Viable Count testing. This includes provision of overtime cover as required, i.e. coverage of late and weekend QC rota, where required
  • Progress QMS in a timely manner, to ensure on-time delivery
  • Immediately escalate and report any deviations to materials, facilities, processes or procedures to line manager
  • Maintain all QC systems, databases, logs and support the generation of QC trend data
  • Adhere to 5S working practices. Identify and implement areas for continuous improvement and escalate to line manager
  • Be accountable for the QC areas being clean, tidy and well-organised and in a state of continuous inspection readiness
  • Perform routine housekeeping activities in QC including cleaning of equipment and laboratory areas and maintenance of equipment including replenishment of liquid nitrogen tanks
  • Ensure that all required training is complete in procedures performed and operate in compliance with best cGMP working practices at all times
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team setting
  • Maintenance of GMP documentation, e.g. review and archiving
  • Shift work and out of hours work as required
  • Undertake any other duties in accordance with company requirements

Experience

  • Degree in biological sciences or relevant experience
  • Knowledge of GMP guidelines and regulatory bodies or biologics/vaccine background would be an advantage
  • Experience managing external relationships for effective delivery i.e. suppliers would be an advantage
  • Experience of Quality Management Systems would be an advantage
  • Experience of raw material testing, sample management and shipping would be an advantage
  • Experience of working to deadlines and managing conflicting priorities

Skills

  • Ability to organise and schedule work within a busy QC department
  • Experience of working to SOP documentation
  • Excellent time management and prioritisation skills
  • Ability to communicate at all levels
  • Flexible and able to efficiently adapt to organisational changes
  • Ability to utilise resources to solve problems
  • Strong attention to detail

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