Qc Scientist

**The Company** ? Our range of immuno-diagnostics reagents includes human antigens, antibodies, enzymes and serum & plasma products. With manufacturing sites spanning four continents, we produce world-renowned labels for lateral flow, ELISA assay and biosensors, includingour high-quality gold nanoparticles and glucose oxidase. The acquisition of German-based DIARECT AG in June 2020 established BBI as the leading provider of antigens in the autoimmune and tick-borne IVD markets. ? BBI Solutions is part of the BBI Group ? **Benefits** The salary offered for this role is competitive and makes up part of BBI’s attractive benefits package, which includes: - 5% contributory pension scheme - Life Assurance - Private health care scheme - Generous annual leave package totalling 32 days (inclusive of bank holidays) - Participation in the childcare voucher and cycle to work schemes ? **The Role** The QC Scientist reports into the QC Team Leader and performs incoming, in-process and final quality control testing across the BBI product range. The QC Scientist will ensure that all QC tests/activities under job description are carried out on time andin line with set specifications, customer requirements, global/site procedures, industry standards and regulations as required. Duties and responsibilities will include, but not be limited to the following: - Carry out incoming, in-process and final testing to support manufacturing and R&D activities using calibrated equipment and in accordance with QC Procedures. - Ensure all documentation is completed following ALCOA principles and with a "right first time" attitude - Report any out of specification or out of trend results and any quality issues to QC Team Leader or Senior Scientist as soon as noticed. - Record and investigate out of specification and out of trend results. - Manage stability trials and perform testing at scheduled intervals, generate stability reports and maintain stability spreadsheets. - Manage QC inventory. - Carry out quality monitoring and trending of the Purified Water System and record results on monitoring form. - Initiate required changes to QC documents in accordance with change control procedures. - Support product development with new documentation generation. - Act as key customer contact for specific products and represent QC at various meetings, including R&D project transfers. - Participate in quality improvement opportunities within QC and support the quality improvement initiatives undertaken by other departments. - Support QC Project Leader and QC Team Leaders with QC Project work. - Maintain laboratory cleanliness - Ensure all external customer communications are managed promptly and professionally. - Ensure that all activities carried out by self are in accordance with site and legislative employment policies and safety requirements. - Ensure all activities comply with Health and Safety legislation or BBI policies ? **The Person** As the QC Scientist, you will need to have a science-based degree, laboratory experience and ideally be familiar with cGMP/ ISO 13485 and working within a regulated environment. Previous exposure to QC processes will be desirable.