Senior 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 Group.We currently have an exciting opportunity for a Senior QC Scientist to join us on a permanent basis at our Crumlin site.BenefitsThe 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)
• Cycle to work scheme

The RoleAs a Senior QC Scientist, you will be responsible for performing in-process and final testing on the BBI Diagnostic product range, including rapid tests, liquid conjugates and gold colloid, ensuring that all QC tests/activities under job description arecarried out on time and in line with set specifications, customer requirements, global/site procedures, industry standards and regulations as required.It is likely that a role may initially be assigned to a specific area of the business (e.g. Systems, Engineering, Lateral Flow, Enzymes), however the nature of the Quality organisation is such that roles will be expected to operate across those differentparts of the organisation so that the right skills are deployed where needed as determined by the business.Key responsibilities will include but not be limited to;

• Carry out in-process and final tests to support manufacturing and R&D activities using calibrated equipment and in accordance with QC Procedures (QCPs).
• Carry out testing of incoming raw materials and record results on Incoming Data Sheets (IDSs).
• Carry out release of conjugates using the Sage ERP system.
• Record and investigate out of specification and out of trend results, also deviations. Alert QC Team Leader to any significant quality problem that is identified by self.
• Manage stability trials and perform testing at scheduled intervals. Record results in QCP and generate reports/maintain spreadsheets.
• Manage QC inventory.
• Carry out quality monitoring and trending of the Purified Water System and record results on monitoring form.
• Carry out cross-over studies on new QC controls, also stability testing at scheduled intervals. Record results in QCP and generate reports/maintain spreadsheets.
• Initiate required changes to QC documents in accordance with change control procedures; similarly, in conjunction with R&D, for new procedures to support product development.
• Prepare a weekly QC schedule for QC Scientists. Review QC Scientists progress daily against the schedule. Re-organise and prioritise the schedule as required.
• Ensure that adequate and independent reviews of all QC records have been carried out by an authorised person prior to acceptance / release of product from QC.
• Ensure documented quality control procedures are implemented and maintained and are available to all department staff.
• Ensure QC staff are trained to conduct their assigned duties.
• Review and maintain all training records for the QC team; ensure all staff have documented training records for the latest version of all QC documents, maintain all QC training files and matrices, and customer specific training files.
• Review and maintain all QC Calibration and monitoring records.
• Act as key customer contact for specific products and represent QC at various meetings, including R&D project transfers.
• Identify and manage quality improvement opportunities within QC and support the quality improvement initiatives undertaken by other departments.
• Inform all relevant departments and/or customer of any inspection/ testing failures. Ensure that all data is trended and review trending data against specifications to identify any out of trend results, specification changes etc. Prioritise actions to manageany non-conformance or quality problem detected by QC and alert QC Manager and / or the Site Compliance Leader of these matters as soon as is reasonably practical.
• Alert QC Manager, as soon as is reasonably practicable, to any significant quality problem that is identified by self, especially if there is a direct impact on products that have already been released to Customers.
• Ensure all external customer communications are managed promptly and professionally.
• Ensure that all activities carried out by self and direct reports are in accordance with site and legislative employment policies and safety requirements.
• Ensure all activities comply with Health and Safety legislation or BBI policies.

RequirementsIf you are 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.This vacancy will close on 30th July 2021.