QC Scientist

Job Description

The CompanyBBI Solutions has been serving the global diagnostics industry for over 50 years, and is the worlds largest independent producer of immuno-diagnostics reagents. We develop and manufacture critical components for the diagnostic industry, but also apply ourexpertise by delivering solutions that bring critical components together in the development and manufacture of point of care and conventional tests. Furthermore, our Novarum Mobile Diagnostic Platform complements across the diagnostics workflow to interpretand share assay results. This makes BBI unique among IVD suppliers.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 GroupBenefitsThe salary offered for this role is competitive and makes up part of BBIs 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 RoleThe 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 PersonAs 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.As an internal employee applying for this vacancy, you and your manager are required to complete an internal transfer form. This needs to be completed in full and attached to your application along with your CV and cover letter.