General Summary
Will review and monitor the quality aspects of all protocol test results. Will implement and monitor appropriate QA/QC of pre-analytical functions (specimen drawing, labeling, processing and test requisitions), analytical (testing), and post-analytical functions (test reporting, specimen storage/shipping) to assure validity of results and chain of custody of specimens. Will ensure the overall safety activities of the laboratory. Requires close work with the Laboratory Quality Manager and Laboratory Director to ensure that the laboratory employees perform their duties in accordance with the requirements of the study protocols, Good Laboratory Practices (GLP) and quality requirements of the Core Lab.
Key Responsibilities
General
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Will help set up competency evaluation program for technologists. Will provide expertise in troubleshooting Lab general or assay problems. Will be expected to travel abroad (e.g., U.S.A & Europe) to attend short-term Laboratory trainings & meetings as required.
Will be responsible for all quality activities pertaining to lab accreditation activities (e.g., CAP) and networks’ regulation compliance (eg. HPTN, MTN, ACTG and IMPAACT).
Administrative
- Monitor laboratory personnel ensuring that work is performed in a timely manner as well as meets the quality standards of the laboratory. Ensure that turn-around-times (TAT) are met.
- Liaise with the Laboratory Quality Manager, Laboratory Administrative Director, study investigators and all the relevant staff ensuring that research and project protocols run smoothly.
- Assists the Laboratory Quality Manager with monthly department meetings, preparing monthly QA/QC reports, safety activities, and other projects as needed.
- Attends regular project staff meetings
Technical
- Train technologists in specific test procedures or QA procedures used in protocol testing
- Provide technical review of bench results prior to data entry.
- Responsible for the final review of lab results.
- Assists with QC review and support of QIP program.
- Responds to technical and logistical problems encountered in the laboratory in a timely manner.
- Works closely with laboratory staff in interpreting diagnostic laboratory tests.
- Monitor critical value response to physicians and clinic staff.
- Works closely with the Laboratory Quality Manager and LA in writing and maintaining laboratory procedure manuals.
- Monitors laboratory staff for compliance with approved procedures.
- Works closely with LA regarding maintenance, monitoring and troubleshooting of problems for all laboratory instrumentation.
- Ensure that daily, weekly, monthly, quarterly and annual maintenance of laboratory equipment is performed properly and in a timely manner.
- Ensures the maintenance of source documents per current laboratory SOP’s.
- Meets or exceeds continuing education requirements for position.
- Organizes study sample shipments as needed.
- Monitors the daily LDMS specimens’ logs and storage reports
Safety
- Will help the Laboratory Quality Manager to monitor the laboratory safety program.
- Follows all laboratory procedures including safety guidelines, the use of personal protective equipment and awareness of blood-borne pathogens.
- Maintains a clean and safe work environment.
Person Specification
Qualifications:
- A master’s degree in Laboratory Science or Bachelor’s degree with 4 years’ minimum experience in a similar position in a comparable laboratory.
- Must have working knowledge of GLP standards and NCCLS procedure formats applicable in a clinical lab.
- Must have experience in hematology, chemistry, Urinalysis, Flow, and/or PCR based assays in a clinical Laboratory.
- Must have a very strong working knowledge of computers.
General
- Demonstrates a cooperative attitude in relationships with co-workers and other personnel.
- Meets or exceeds quality assurance levels of the laboratory and collaboration.
- Maintains confidentiality of patients, patient results and project operations.
- Serves as an effective representative to physicians, nurses, counsellors and visitors in a courteous and empathic manner.
- Follows laboratory and collaboration polices.
- Uses all facilities and supplies with care and in a cost-effective manner.
- Assist or carry out other duties as assigned by the Laboratory Quality Manager and/ Laboratory Administrative Director.