QC Microbiology Analyst
Based in Haverhill, Suffolk
About the Opportunity
Join a diversified Biopharmaceutical company with a unique culture that's known for its innovation learning and growth. A company that's making a very real difference by caring for our patients, our community and our Team members. Quality are a dedicated team who operate across all areas of the business. We continuously ensure that our unique sets of products are manufactured with patient needs at the fore front.
The purpose of the role is to be responsible for analysis (sample/equipment), review and collation of experimental data against specifications laid down by the Quality department.
About Sanofi Business Unit
This position provides the successful candidate with an opportunity to work in a fast-paced Microbiology environment and an opportunity to contribute to projects that are key to the site’s growth and expansion.
You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
· Documenting and Reporting of Microbiological sampling and testing according to cGMP.
· Sampling and analysis of drug substances and drug products.
· Sampling of Purified Water and Recovered Water from manufacturing plant and performing Bioburden testing of water.
· Collection and processing of Environmental Monitoring samples from Microbiology lab and manufacturing plant and performing the testing.
· Performing Media and Reference organisms testing.
· Perform identification of microorganisms isolated from the microbiological tests and samples.
· Collation of testing data into release packs and generation of C of A’s as required.
· Review of raw data, where appropriate, ensuring all documented results are in accordance with the appropriate product/ material specification and good documentation practice.
· Responsible for first line troubleshooting.
· Contributes to continuous improvement.
· May work across value streams working in accordance with the planned QC rota.
· Training and support of others where appropriate.
· Support projects on required basis.
· Perform equipment requalification’s, calibrations, services etc.
· Ensure that equipment assigned is maintained and fit for purpose against site procedures before use.
· Support the capital purchasing process for QC.
· Carry out Risk/ COSHH assessments and ensure that the laboratory is maintained in a safe manner at all times.
· Carry out laboratory maintainance (House keeping / stock control) and supporting the re-ordering and communication with key suppliers.
· Raise the deviations, participate the Root cause Analysis, Identify Corrective and Preventive actions and complete all corrective and preventative actions within the agreed timelines.
· Maintain core training and prior to conducting any activity ensure you are trained in the current version.
· Responsible for personal safety and that of others, reporting all accidents and unsafe acts and conditions.
· Identify and implement improvements to ways of working with an aim to standardize each working week.
· Take responsibility for adhering to cGMP requirements during all activities performed and seek clarification of requirements when they are unclear.
· Demonstrated ability to work consistently to quality policies and cGMP.
· Proven, sustained competence in Microbiology techniques and skills relevant to group.
· A working knowledge of laboratory health and safety.
· Demonstrated ability to successfully manage own workload to meet departmental targets.
What Sanofi can offer you:
· A role where you are instrumental to creating best practice and as the organization grows, you can too.
· We offer a generous package including flexible benefits and are committed to helping you have a healthy work-life balance throughout your career with us.
· We have a subsidized restaurant with free tea and coffee.
· Promoting well being actively on site and having regular activities for the employees (ex: Gardening, Games room with Table tennis, Bee keeping, Pilates, walks, Boot camps).
· Looking into the personal development of the employees relevant to the job roles.
Empower Life Everyday
At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. Sanofi has the capabilities and resources to support your aspirations to fulfill your ambitions and be the best you can be.
Our purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence, which means we’re not there to try to solve everybody’s problems. We want to focus on those areas where we know we are making a difference.
The values we are live by are teamwork, courage, respect and integrity.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.