Senior Qc Scientist

The BBI Group aim to create a world where everyone has the opportunity for a better quality of life. Due to our continued growth, we are seeking a Senior QC Scientist to join our Quality team. This is a permanent, full
- time position based at our facility in Cape Town.

**About BBI Solutions**

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, including our 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.

**Role Overview**
The Senior QC Scientist, reporting to the QC & Microbiology Laboratory Supervisor, will be responsible for ensuring that routine and non-routine analyses of intermediate, final products and investigation work are carried out in compliance with laboratory systems in accordance with Good Laboratory Practices, cGMP and ISO13485 standards.
They will utilize specialised equipment and advanced analytical techniques to provide support to operations, team members, including cross functional investigations.
The Senior QC Scientist will assist in the developing of new analytical techniques and where applicable will train new laboratory staff members.
It is likely that a role may initially be assigned to a specific area of the business, however the nature of the Quality organisation is such that roles will be expected to operate across those different parts of the organisation so that the right skills are deployed where needed as determined by the business.

**Role Requirements**
- Qualifications and experience: _
Tertiary qualification in Biochemistry/Biotechnology/ Chemistry/Analytical Chemistry
Alternatively, +10 year’s relevant equivalent experience
Product and product specification knowledge.
Knowledge and experience of Good Laboratory Practices and/or ISO13485 and/or cGMP.
Laboratory instrument knowledge.
- Key responsibilities will include but are not limited to: _
- Analyse all samples according to the relevant specifications and according to approved test methods and laboratory standards.
- Physical inspection, sampling, testing and labelling of incoming raw materials.
- Recording and publishing/reporting of results to relevant personnel with the appropriate urgency and to allow SPC plotting.
- 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 manage any non-conformance or quality problem detected by QC and alert QC & Microbiology Laboratory Supervisor / or the Site Quality & Regulatory Leader of these matters as soon as is reasonably practical.
- Responsible for reporting the status of consumables/stock levels to the Laboratory Supervisor.
- Report on specification results and conduct primary investigation of out of specification results and solve technical problems.
- Supports any testing for cross functional investigations.
- Reports faulty equipment to the Laboratory Supervisor.
- Ensure laboratory equipment is within calibration period.
- Adhere to and assist with company standards/programs e.g. Health and Safety programme, GLP and GMP.
- Take part in Proficiency Testing when required.
- Ensure personal training plan is achieved.
- Develop and optimize test methods.
- Review and write laboratory procedures.
- Manage stability trials and perform testing at scheduled intervals. Record results on QMS system.
- Carry out sampling and quality monitoring of the water systems and record results received from external laboratories.
- Organise environmental monitoring plates and swabs to be taken and sent for testing at external laboratory. Collate results.
- Participate in quality improvement opportunities within QC and support the quality improvement initiatives undertaken by other departments.
- Alert QC Laboratory Supervisor, 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 QC staff are trained to conduct their assigned duties.
- Ensure training is documented and submitted to QC Laboratory Supervisor.
- Act as back up for the QC Laboratory Supervisor in the event of their absence

**Benefits**

Here at BBI, we are committed to promoting and protecting the physical and mental health and well-being of all our employees. They play a pivotal role in improving the quality of people’s lives and are focused on delivering exceptional products and technologies. With our employees focused on others, we’re focused on them. That’s why, at BBI, we’re dedicated to providing our employees with access to global resources and site
- specific benefits that support their health and w