Biomedical Specialist: Evaluations and Projects
Listing reference: sanbs_000009
Listing status: Closed
Apply by: 5 February 2021
Position summary
Industry: Medical Technology
Job category: Medical Research and Laboratory Sciences
Location: Durban
Contract: Fixed Term Contract
Business Unit: Mount Edgecombe
Remuneration: market related
EE position: Yes
Introduction
Perform evaluations /validations of new reagents, kits, methods, equipment, and instruments for the various sections in the Specialised Laboratory Services Department, assist in the completion of reports/SOPs
and provide training where required. Assist the Senior Biomedical Scientist, Molecular R&D with the Laboratory Services Unit (LSU) with regards to the staff, safety, quality, and operations and deputize this area in their absence.
This position is based in Mount Edgecombe.
Job description
KPA 1 Operational Duties
KPI
1.1 Ensure that routine and non-routine processes are performed and/or implemented according to SOP.
1.2 Ensures the appropriate maintenance of records (manual and electronic).
1.3 Monitor stock usage and wastage of test kits, reagents and laboratory consumables and take appropriate action if necessary in order to minimize costs.
1.4 Formulate requisitions and reservations for laboratory consumables, if required.
1.5 Collate, analyse and report monthly operational statistics to the Senior Biomedical Scientist.
1.6 Complete Risk Management tasks identified and ensure the completion of tasks.
1.7 Assist with resolving errors and customer complaints and responding to customer compliments according to the measures within the balanced scorecard for the LSU and Molecular R&D areas.
1.8 Assists the Senior Biomedical Scientist, Molecular R&D with deputizing for the LSU section in their absence.
KPA 2 Monitor SHEQ
KPI
2.1 Ensure operational compliance by the management of non-conformances through review of root cause analysis and implementation of required corrective action within agreed timeframes.
2.2 Compliance to safety policies and procedures.
2.3 Compliance to policies and procedures to ensure that accreditation requirements are implemented and maintained.
2.4 Identify systems non-conformances and elevate problems and/or solutions to the Senior Biomedical Scientist: Molecular Research and Development.
2.5 Personal compliance to Continuous Professional Development (CPD) requirements by attending and/or presenting lectures or educational seminars and congresses and assisting staff meet CPD requirements by hosting CPD training talks/journal clubs.
2.6 Monitor maintenance and calibration programmes for the LSU laboratory and check that equipment in the work areas in use as per specific projects are maintained before use.
2.7 Track and follow progress on all documents in the role of SAP Author or Validator.
2.8 Attend S&E meetings and provide feedback to LSU staff timeously.
2.9 Ensure that all S&E, Spill Kits and PPE registers are maintained on a monthly basis for LSU and the PPE registers are maintained for Molecular R& D.
2.10 Assist the Safety & Environment Department and LSU to control the Tracking and Traceability of Waste through the Waste Management System in place. This includes assisting with issues when LSU ae deputising for the environmental controller function.
KPA 3 Provide technical expertise to internal and external customers / stakeholders
KPI
3.1 Provide molecular expertise to stakeholders in Immunohaematology and Tissue Immunology.
3.2 Assist the Senior Biomedical Scientist, Molecular R&D and various Specialised Laboratory Services Department stakeholders with regards to problem solving and troubleshooting as and when required.
3.3 Assist the Senior Biomedical Scientist, Molecular R&D and various Specialised Laboratory Services Department stakeholders with regards to the appropriate action to be taken in the event of product or process failure. Provide regular feedback reports on corrective actions and effectiveness of corrective actions.
KPA 4 Completion of Evaluations and Projects
KPI
4.1 Keep abreast of current trends in technology and methodology and collaborates on a regular basis with the Senior Biomedical Scientist, Molecular R&D in gaining approval for the projects.
4.2 Proactively assists with identifying resources, sourcing reagents, kits, and consumables and obtaining validation samples in conjunction with the Senior Biomedical Scientist, Molecular R&D.
4.3 Assists the Senior Biomedical Scientist, Molecular R&D in the development of project plans.
4.4 Completes projects by the agreed deadlines. Investigate and resolve all troubleshooting errors with technical expertise in the field or with product specialists and document corrective and preventative actions.
4.5 Analyses and collates all results and necessary documents and assists in the preparation of the final Evaluation/Validation reports, and load approved documents onto the Document Management System (SAP).
4.6 Develop and validate standard operating procedures (SOP’S) for all new processes or review SOP’s where required by the stipulated timeframes and complete training of staff to competency and ensure smooth implementation of new methods/kits/reagents.
4.7 Submit monthly progress reports on projects and submit motivations to justify extensions on deadline dates to the Senior Biomedical Scientist, Molecular R&D.
Minimum requirements
Education
- HPCSA Registered Medical Technologist (Blood Transfusion/Clinical Pathology/Immunology) or, HPCSA registered Medical Biological Scientist.
Experience and knowledge requirements
- 3 years laboratory experience.
- 2 – 3 years or experience in advance Red Cell Serology/Molecular/Immunology.
Other (knowledge and skills), e.g. under-standing
- Employee relations, general people of relevant legislation; knowledge of relevant company procedures management.
- Understanding of Blood Transfusion Standards.
- Understanding of HPCSA regulations.
- Understanding of SANAS regulations and audit process.
- SAP and LIMS systems.
- Project Management.
