Epu Laboratory Technician

**Job Advert Summary**:

- Routine production of enzyme-linked immunoassays (ELISA) reagents and kits. Perform ELISA techniques, assays and quality testing of ELISA kit components.
- Perform QC testing of ELISA kit components and final kits prior to release.
- Testing and dispensing of anti-D reagent for routine production of anti-D kits.
- Laboratory resourcing and Quality system requirement maintenance

**Minimum Requirements**:

- BSc in Biochemistry, Biotechnology, Diploma in Analytical Chemistry is essential
- BSc Honours in Biochemistry, Microbiology, BTech Analytical Chemistry an added advantage
- 1-2 years ELISA technology experience
- 1-2 years in a GMP analytical laboratory environment
- Computer Literacy in MS Office and SAP
- Working Knowledge of ISO13485:2016 quality system

**Duties and Responsibilities**:
**Routine production of ELISA reagents and kits.**

Produce ELISA kits and reagents by:

- Preparing plate coating reagents, conjugate reagents
- Occasionally assisting with kit assembly procedures including vialing, labeling and assembly
- Performing in-process testing of ELISA kit reagents (pH, visual checks on coated plates and freeze-dried reagents)

Prepare the conjugates, controls, and standards for the different ELISA kits by:

- Dilute the controls, standards and conjugates according to work instructions and QARM reports.

Prepare the lyophilized reagents according to work instructions (Bosine, Conjugate Diluent and OPD).

**QC testing of ELISA reagents, components and final kits.**
- QC testing of all ELISA reagents, components and final kits during the different production stages.
- Complete documentation for all kit components, upload results into LIMS and send to QARM analyst.
- Complete documentation for final kits and upload results on SAP.

**Dispensing and Testing of Anti-D reagent**

Testing of bulk Anti-D reagent (active ingredient in the Rapidtest Rh kits) by performing the following in process quality control checks serological tests:

- Perform visual checks for any precipitates, gel formation or particles in the bulk Anti-D reagent.
- Identify the bulk Anti-D reagent using red blood cells.
- Dilute and titrate the bulk Anti-D reagent against red cells
- Test known blood samples for confirmatory Rhesus typing.

Assist in the dispensing and labelling of the Anti-D reagent for the Rapidtest Rh kit.
- Dispense the correct volume of the Anti-D reagent, cap and label the dispensed reagent.
- Perform final QC checks on the dispensed Anti-D reagent.
- Complete documentation and upload into SAP.

**Laboratory resourcing and Quality system requirement maintenance**
- Perform equipment and test method validations according to the internal Biotechnology program.
- Troubleshooting of hyperimmune ELISA kits for QARM to resolve quality issues when required.
- Assist EPU Section Head with the compilation and review of work instructions for ELISA processes and equipment on SAP DMS.
- Conduct stability studies of ELISA kit components, reagents and final kits to establish shelf life. If required
- Evaluate new raw materials to ensure maintenance of quality standards as part of NBI’s formal change management system.
- Assist with investigation reports for notifications created for out-of-specification results and other incidents.
- Cleaning and maintenance of equipment
- Calibrate laboratory equipment (pH meter, balance, Aquamax plate washer and Biotek plate dispenser

**Core Competencies**
- Managing Relationships
- Personal Leadership
- Business Impact
- Leading and Influencing others
- Collaboration and teamwork
- Technical/Professional knowledge and proficiency
- Attention to detail and analysis
- Written and verbal communication
- Collaboration/Team Work
- Customer service orientation