- 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.
- To ensure appropriate trending is up to date to allow the reporting of the rolling monthly environmental monitoring report in a timely manner.
- Be responsible for the development, collating and reporting of key quality and business metrics, and use such metrics to drive a culture of continuous process improvement within the area of responsibility.
- Conduct on-time reporting according to the defined and trained 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 SOP's, Change Control, Deviations, CAPA's.
- Identify areas for continuous improvement and escalate those to the Microbiological Manager and QC Head of Department.
- Actively contribute to the development and maintenance of an enthusiastic, supportive, and collaborative environment within the team-setting.
- 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.
- Working within a QC laboratory environment, working to GMP within a recognised quality system.
- Minimum of 2 Years experience of working 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, CAPA's, Change Control.
- Experience in Environmental Monitoring.
- Technical experience and understanding 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.
- Experienced in relationship handling with external bodies, such as suppliers, regulatory and audit authorities.
- Good organisational and time management skills.
- Excellent communication skills.
- Effective people management skills i.e. leadership, engagement, and motivation.
- Stock Options
- Employee Assistance Programme
- Gym membership OR fitness allowance
- Free Fruit
- Many others included
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Senior QC Microbiology Technician - Livingston, United Kingdom - Valneva
Description
Valneva is a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. Our focused pipeline includes the world's first vaccine against the chikungunya virus, the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, as well as vaccine candidates against the Zika virus and other global public health threats
Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.
Please find a link to our corporate video for a quick insight into Valneva
The successful applicant will be expected to supervise and perform Microbiological tests for the release of raw materials and intermediate products according to defined procedures and protocols. Oversee the daily running of the laboratories and support the Microbiology Manager, acting as a subject matter expert and supporting during regulatory inspections.
Requirements
Experience
Required Skills
Benefits
