Quality and Projects Technician
Job Details
Full Job Description
Job category: Health, Fitness, Medical and Optometry
Location: Roodepoort
Contract: Temporary
Business Unit: Constantia Kloof
Remuneration: R 498,472.00
EE position: No
IntroductionSANBS 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.
Quality And Projects Technician
South African National Blood Service
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