Senior QC Technician (Micro)

Overview

We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We have leveraged our expertise and capabilities both to commercialize three vaccines, including the world's first and only chikungunya vaccine, and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease and Zika. With operations in Austria, Canada, France, Sweden, the United Kingdom, and the U.S., we are committed to making a positive impact on global public health. Together, we are a global Company which is open to people of all backgrounds. Our diverse and inclusive workforce makes Valneva a great place to work.

Role

We are seeking a skilled and versatile Senior QC Technician (Micro) to join our team. To supervise and perform Microbiological tests for the release of raw materials and intermediate products according to defined procedures and protocols. Provide technical expertise in Microbiological assays and drive projects to completion to agreed timelines. Oversee the daily running of the laboratories and support the Microbiology Manager.

Responsibilities

• Execute Microbiological procedures including Endotoxin Kinetic Chromogenic Method, Total Viable Count Testing, Growth Promotion including Environmental Isolates, Microbial Growth Check by Incubation, Environmental Monitoring including Gowning and Compressed Gases, and any other testing as required by the Line Manager.
• Apply cGMP work-practices and techniques to test and release raw materials and intermediate products.
• Ensure that all QC technicians are appropriately trained and competent in the procedures they are conducting and are following cGMP working practices at all times.
• Ensure appropriate trending is up to date to support the rolling monthly environmental monitoring report.
• Be responsible for development, collating and reporting of key quality and business metrics, and use such metrics to drive continuous process improvement within the area of responsibility.
• Conduct on-time reporting according to defined document management standards including review and verification of microbiological data provided by the QC technicians.
• Immediately escalate and report any deviations to materials, facilities, processes, or procedures to the Manager.
• Be accountable for the microbiological laboratories being clean, tidy, and well organised and in a state of continuous inspection readiness.
• Write QMS documentation including SOPs, Change Control, Deviations, CAPAs.
• Identify areas for continuous improvement and escalate those to the Microbiological Manager and QC Head of Department.
• Contribute to a positive, enthusiastic, collaborative team environment.
• 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

• Working within a QC laboratory environment, working to GMP within a recognised quality system.
• Experience in a Supervisor/Senior role.
• Ability to prioritise, organise and schedule work within a busy laboratory.
• Experience of writing and working to SOP documentation.
• QMS experience in writing Deviations, CAPAs, Change Control.
• Experience in Environmental Monitoring.
• Technical experience in microbiological assays such as Sterility, Endotoxin, Mycobacteria & Mycoplasma.
• Understanding of the European and U.S. Pharmacopeia desirable.
• Validation and qualification of assays knowledge would be advantageous.
• Experience driving a team to achieve individual, team and organisational objectives.
• Experience in relationships with external bodies, such as suppliers, regulatory and audit authorities.

Benefits

• Stock Options
• Employee Assistance Programme
• Gym membership or fitness allowance
• EV Salary Sacrifice
• Many others included

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