QC Specialist Clinical Pathology
Position summary
Introduction
Job description
KPA 1 Operational (Clinical Pathology And Critical Materials)
KPI
1.1 Collect and/or Receive and perform Quality Control analysis of Blood products, Therapeutic donors, Biochemicals and Saline according to SOP with-in agreed turn-around times, including:
1.1.1 Full Blood counts (Haemoglobin, Haematocrit, HCV, MCH, MCHC, Red Cell count, Platelet count, and White blood cell count).
1.1.2 Flow cytometry testing for low level Leucocyte counts and Stem cell testing.
1.1.3 Chemistry related testing for total protein levels.
1.1.4 pH testing.
1.1.5 Coagulation testing (Fibrinogen and FVIII levels) (if applicable).
1.1.6 Microbiology Testing including: Sterility testing using direct inoculation methods/ culture plates, staining and identification (if applicable).
1.1.7 Water purity testing by filtration method (if applicable).
1.1.8 Environmental monitoring of all apheresis clinics and processing centres nationally to ensure effective disinfecting processes are followed. (If applicable).
1.1.9 Transfusion Reactions (If applicable).
1.1.10 Reconstitute controls and organism strains (Micro banking) and aliquot for storage (If applicable).
1.2 Accurate entry and verification of results on Meditech.
1.3 Check results and assign repeat or additional tests as required.
1.4 Print outstanding reports and sign off.
1.5 Schedule and perform maintenance and calibration on all instruments and equipment according to procedures
1.6 Receive and perform CD34 testing on stem cell collections (CK only)
1.7 Perform internal and external Quality Control, assess results and implement corrective action when required according to procedure.
1.8 Perform accurate Quality Control (QC) of incoming goods, commodities and printed materials by travelling to warehouse on a weekly basis to sample materials.
1.9 Test materials according to specifications, record results, enter and release results onto SAP and submit all documentation to head of QC according to procedure with-in agreed time frame.
1.10 Perform calibration and revalidation of thermometers as per SOP and prepare certificates for thermometers.
1.11 Validation testing of all critical materials, from suppliers, new equipment and processes according to validation protocol.
1.12 Documents and reports non-conformances.
1.13 Effective participation in internal auditing functions.
1.14 Responsible for technical and administrative duties in the absence of the head of QC that is consistent with role and function of the position.
KPA 2 Quality Management
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 Compile SOP's by reviewing new and revised versions within the required timeframe and validating procedures and maintaining competency for the stipulated SOP.
2.3 Compliance to safety policies and procedures.
2.4 Compliance to policies and procedures to ensure that accreditation requirements are implemented and maintained.
2.5 Identify systems non-conformances and elevate problems and/or solutions to the Head of QC Laboratory
2.6 Ensure ongoing compliance for Continuous Professional Development (CPD) requirements.
2.7 Monitor and schedule maintenance and calibration programmes for the laboratory.
2.8 Assist with resolving errors, deviations from SOP's and customer complaints according to the measures within the balanced scorecard.
KPA 3 Risk Management
KPI
3.1 Assist the Head of QC Laboratory and various stakeholders with regards to problem solving and troubleshooting as and when required.
3.2 Assist the Head of QC Laboratory on deciding on the appropriate action to be taken in the event of product or process failure.
3.3 Assist the Head of QC Laboratory with the validation and implementation of new technologies within the laboratory.
3.4 Attend and/or present lectures or educational seminars and attend congresses to update knowledge and accrue CPD points.
3.5 Address queries from internal and external stakeholders timeously.
3.6 Build and maintain effective relationships and provide good customer service
KPA 4 Deputation And Training Duties
KPI
4.1 In the absence of the Head of QC Laboratory perform the following technical duties:
4.1.1 Review results on Meditech.
4.1.2 Check results for accuracy and interpretation and prepares reports for timeous dispatch when required.
4.1.3 Liaise with the Apheresis and Processing centres regarding non-compliant products.
4.2 In the absence of the Head of QC Laboratory assist with the following staff related duties:
4.2.1 Organise and co-ordinate the testing of incoming specimens.
4.2.2 Track and monitor the progress of testing and reporting to ensure service delivery.
4.3 In the absence of the Head of QC Laboratory provide the following information/documentation as and when required:
4.3.1 Submit information to the Finance Department for billing purposes.
4.3.2 Provide operational statistics for the Balanced Scorecard to the QC Manager.
4.4 Training and certification of relevant staff.
4.5 Provides training (theoretical and practical) to external staff (registrars and medical students) when required.
KPA 5 Financial And Administrative Functions
KPI
5.1 Monitor stock availability, usage and expiries.
5.2 Submit CAPEX requirements for laboratories to the Head of QC Laboratory.
5.3 Monitor stock and usage of test kits and reagents.
5.4 Formulate requisitions and reservations for laboratory consumables and order via SAP.
5.5 Distribute and file documents and reports.
5.6 Archive Laboratory records.
5.7 Generate laboratory reports monthly.
Minimum requirements
Education
Diploma in Biomedical Technology.
Registered Medical Technologist in Clinical Pathology.
Registration with a professional body HPCSA.
Experience and knowledge requirements
Other (knowledge and skills), e.g. understanding of relevant legislation; knowledge of relevant company procedures
Be familiar with the accreditation guide (ISO:15189) for diagnostic purposes and (ISO: 17025) for lab
Understanding of Blood Transfusion Standards
Understanding of HPCSA regulations.
Understanding of SANAS regulations and audit process.
SAP and Meditech oratories and good laboratory practice.