Epu Laboratory Analyst

**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**:

- Essential: BSc in Biochemistry, Biotechnology, Diploma in Analytical Chemistry
- Preferred: BSc Honours in Biochemistry, Microbiology, BTech Analytical Chemistry
- 1-2 years ELISA technology experience
- 1-2 years in a GMP analytical laboratory environment

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

Produce ELISA kits and reagents by:

- Prepare plate coating reagents, conjugate reagents
- Occasionally assist with kit assembly procedures including vialing, labeling and assembly
- Perform 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)
- Consistently demonstrate NBI’s Future Focus Behaviours (FFB) (in professional interactions).

**Core Competencies**
- Performance management
- Leading and influencing others
- Managing Relationships
- Business Impact
- Working Knowledge of ISO13485:2016 quality system
- Technical/Professional knowledge and proficiency
- Attention to detail and analysis
- Written and verbal communication
- Computer Literacy in MS Office and SAP