Quality And Projects Technician

Job category: Health, Fitness, Medical and Optometry
Location: Roodepoort
Contract: Temporary
Business Unit: Constantia Kloof
Remuneration: R 498,472.00
EE position: No
Introduction SANBS is looking for a Quality and Project Technician to support Donation Testing in all areas of Quality and Projects to ensure accreditation is maintained and projects completed effectively and timeously. To maintain the operations of the Bio repository in JHB and to coordinate requests of NAT and serology positive plasma from the Donation Testing Department.
Key Performance Areas 1 Operational objectives - Bio Repository
1.1 Maintain an effective storage and retrieval system for plasma packs and prospective samples and ensure that plasma repository database is maintained within the agreed number of days of a transaction occurring. Following up on packs not received and track plasma units requested from zones
1.2 Record all relevant information on the system within the agreed number of days of transaction occurring.
1.3 Strive to avoid contamination by working according to GLP.
1.4 Sort and aliquot viral positive packs within the agreed number of days from receipt. Print barcodes to label aliquot tubes.
1.5 Send samples to external reference laboratories for miscellaneous tests within the agreed number of days. Follow-up and track results.
1.6 Receive and check invoices for external testing. Liaise with supplier regarding queries.
1.7 Receive miscellaneous, follow up and retest samples, look up required tests in LIMS and distribute to relevant section for testing. Receive record and distribute follow-up test results according to SOP specifications.
1.8 Make arrangements for the transfer of viral positive plasma and aliquots of NAT and Serology yields to the Bio-Repository in Gauteng.
1.9 Send samples and supply requested plasma to the Virology Reference Laboratory for further testing.
1.10 Assist with trials and projects by retrieving, aliquoting, distributing and tracking plasma and samples.
1.11 Record all discard of material and unit status changes on relevant information systems.
1.12 Maintain daily traceability records of all material entering and leaving the repository to ensure that requests are met in a timeous manner.
1.13 Prepare and pack positive materials for shipment to other institutions according to IATA/WHO packing instructions.
1.14 Receive lookback plasma, check and send for relevant testing, update on database and send results to the Medical Division.
1.15 Perform daily, weekly and monthly laboratory maintenance as per schedule, ensuring that accurate records of maintenance performed are kept
1.16 Document and dispose of samples, used reagents and waste material according to prescribed safety regulations
2 Operational Objectives - Quality and Projects

2.1 Assist Quality and Projects Manager / Supervisor with projects, evaluations (instrument and diagnostic reagents), validations, verifications and installation qualifications.
2.2 Coordinate quality assurance proficiencies.
2.3 Manufacture quality controls by selecting candidate viral positive blood units for processing from the test results database, obtaining selected units via the Processing and Issuing department to facilitate virus inactivation, titration, standardisation, classification, alliquoting, documentation and distribution to the NAT, Virology and Blood Grouping sections nationally.
2.4 Maintain documentation of control manufacture according to SOP criteria and submit batch reports to the Quality and Projects Supervisor / Manager timeously.
2.5 Perform daily audits of donor and unit status changes reflected on the Meditech computer system as a consequence of disease marker results and confirm positivity.
2.6 Compile daily and monthly summary reports of all marker positive unit processing and donor status change information as well as any non-conformance and subsequent corrective action information generated during the month.
2.7 Maintain traceability of reactive units by ensuring that red blood cells and buffy coats are destroyed according to SOP criteria and that plasma is timeously forwarded to the Plasma Repository and when not done inform the zones of outstanding tasks and report as non-conformances were necessary.
2.8 Transfer appropriate results from the laboratory information systems and compile daily, weekly and monthly reports of internal control and external quality control performance and submit these to the Quality and Projects Supervisor.
2.9 Provide technical support to avoid short-handedness in the Blood Grouping Section in the absence of sufficient staff as well as performing trouble shooting in conjunction with the external service engineer in the case of system failure.
3 Quality compliance in accordance with SOP specifications.

3.1. Contribute to SOP control by ensuring that current versions are in place, ensuring that obsolete versions have been destroyed according to SANBS policy and by maintaining competency for the stipulated SOPs
3.2. Contribute to SOP compilation by reading new and reviewed versions within the required timeframe and assisting with the writing and validation processes.
3.3. Contribute to and participate in continuous quality improvement by adhering to SOP criteria and providing feedback to relevant parties.
3.4. Comply with CPD regulations by obtaining the required number of CEU points for CPD and conducting training sessions in accordance with HPCSA regulations and IPA specifications.
3.5. Maintain quality standards and safety practices by complying with SOP and SHE requirements.
3.6. Keep the Quality and Projects Supervisor informed by documenting all errors and ensure that these amount to less than the agreed upon percentage of total processes per month.
3.7. Coordinate archiving of documents for the department to ensure that test results and data can be timeously acquired and retrieved when required.
3.8. Maintain service schedule for all instrumentation by inspecting instrument logs to ensure that service and maintenance is performed as scheduled and according to SOP criteria and manufacturer specifications.
3.9. Monitor temperature monitoring system for all DTD fridges, freezers and equipment on a daily basis and report any deviations to Q&P Supervisor.
3.10. Comply with internal and external audits as well as QC and proficiency Testing.
3.11. Check BI report on weekly basis for all notifications due for closure, overdue notifications, and escalations, follow up and report to Q&P Supervisor
2.12. Validate new reagent shipment sensitivity by testing against known controls as well as new reagent batch specificity by testing against known reactive material to ensure that the cold chain and correct storage conditions have been maintained.
2.13. Compile reagent lot disposition certificates and validation reports and distribute them to JHB and KZN within IPA agreed timeframes.
2.14. Monitor Virology, Blood Grouping and NAT system performance by comparing mean control values by assay, batch, instrument and operator and compile reports of system performance to facilitate accurate and timeous reporting of out of range deviations to the Quality and Projects Supervisor / Manager
2.15. Inform the Quality and Projects Supervisor / Manager immediately of any trends, spikes or shifts in the quality assurance performance charts so that proactive investigation can occur.
2.16. Perform installation qualifications and validations on all diagnostic instrumentation, software upgrades and diagnostic reagents according to manufacturer specifications and in conjunction with the relevant Supervisor / Technical Specialist
2.17. Maintain service schedule for all instrumentation in conjunction with the section supervisor / technical specialist, by inspecting instrument logs to ensure that service and maintenance is performed as scheduled and according to SOP criteria and manufacturer specifications.
4 General administrative functions and additional duties have been carried out within specified timeframes

4.1. Retrieve, collate and supply statistical information to facilitate completion of the departmental scorecards
4.2. Perform with stock checks to maintain adequate stock levels to ensure timeous responses to relevant requests.
4.3. Maintain accurate and up to date records of results to ensure ease of retrieval and review.
4.4. Check manual entry of results into Laboratory Information System (LIS) to ensure that all relevant information is available and accurate.
4.5. Archive documents for the department to ensure timeous acquisition of test results when required.
4.6. Perform other job related duties as and when required by the Q&P supervisor or manger to facilitate efficient running of the laboratory e.g. monitoring IQAS stock, sending Blood Grouping samples to QC lab for internal Grouping QC.
4.7. Perform weekend/out of hours duties in the Donation Testing Laboratory.
4.8. Maintain effective Traceability of waste containers required for discarding waste in DTD
4.9. Assist with booking of flights, accommodation and transport for DTD KZN staff
4.10. Check and ensure invoices for Q&P are processed for Good Receipt (GR). Submit information to the Finance Department for billing purpose
5 Deputisation and Training

5.1. In the absence of the Quality and Projects Supervisor provide the following information/documentation as and when required but not limited to:
5.1.1. Provide operational statistics and cost centre report information for the Balanced Scorecard to the Manager: Donation Testing
5.1.2. Provide training (theoretical and practical) to external staff (registrars and medical students) when required
5.1.3. Perform staff supervision to ensure the continued running of the laboratory.
5.1.4. Perform all functions normally performed by the Quality and projects Supervisor.
5.2. Train and certify Donation Testing staff to relevant Quality and Biorepository SOPs and functions
5.3. Assist the Q&P Supervisor with documentation and tracking of customer complaints / compliments and queries
5.4. Promote education by conducting guided tours for schools, the general public and media to ensure that information provided is directed at the level of the relevant audience.
Education • HPCSA Registered Laboratory Technician or Technologist (Blood Transfusion)
Experience and knowledge requirements  • 2 years Blood Transfusion Experience

Other (knowledge and skills), e.g. under-standing of relevant legislation; knowledge of relevant company procedures • Standards of Practice for Blood Transfusion in SA.
• Relevant SANBS policies and procedures.
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