Summary
Date Posted: Wednesday, March 06 2024, Base Salary: Not Disclosed

JOB DETAILS:
Description:
Reports to QAQC Manager. The incumbent will be required to provide support to all protocols and research teams. S/he will work closely with QA/QC Manager, Operations Manager, and all Lab Management team in developing procedures and ensuring that all procedures are ready in time for start of any study/research protocol.

Main duties
• Works with the QA/QC Manager and laboratory leadership to define and maintain research objectives, targets, and processes and review new targets, protocols, processes, equipment, supplies, and technologies for quality standards.
• Takes a leading role to review all protocol related documents (study protocols, MOPs, LPCs and other documents), train personnel and ensure smooth implementation of respective protocols.
• Works with the QA/QC Manager to ensure adherence to research protocols by all laboratory personnel involved in protocol activities.
• Plans and appropriately documents protocol related trainings.
• Ensures that all specific protocol documents are current, controlled and appropriately filed.
• Works with the QA/QC Manager to develop, implement, communicate, and maintain protocol analyte lists (PAL).
• Ensures that all study/research related laboratory SOPs are written and maintained as per quality policy and procedures.
• Submits protocols for regulatory approvals as may be required.
• Responsible for QA/QC of all protocol and research samples to be shipped internationally. Ensure that all chain of communications have been completed before shipment as required by specific protocol procedures.
• Creates a QA/QC plan for regular review and spot check for protocol specimens in LDMS and LIMS storage.
• Tracks and maintains competencies for all personnel working on research protocols.
• Works with the Operations Manager and Pre/Post Analytical supervisor to ensure that LDMS reviews, storage verification, discrepancies resolutions, assay applications (DNA & RNA & data exportation) are conducted in a timely manner.
• Gains and maintains competency for LDMS and sample shipment procedures including IATA certification. The research coordinator is also responsible for ensuring that all competencies and certifications are maintained for personnel using LDMS and shipping samples internationally.
• Actively participates in the process of achieving and maintenance of ISO 15189 accreditation and any other certification as may be required.
• Works with the QA/QC Manager in the designing of an internal audit process, including checklists, schedule of implementation, reporting of findings, resolution action plans, implementation of corrective and preventive actions and subsequent documentation.
• Participate in the process of preparing the laboratory for external audits.

Qualifications
• Degree in Biomedical Sciences. Masters is an added advantage
• Registration with HPCZ is required.
• At least 5 years’ experience at Laboratory management level is required.
• At least 5 years working in a laboratory that involves handling of high-volume research specimens is required.
• Experience with a variety of laboratory quality management systems, e.g., CAP, ISO, and CLIA. In-depth knowledge of GCLP and ISO 15189 is an added advantage.
• Ability to function independently and as a member of a large team; motivate people to achieve excellence; work with multiple leadership and staffing levels to achieve quality management goals.
• Good working knowledge of research patient consenting and documenting protocol deviations.
• Must have excellent communication skills, both verbal and written.
• Experience in qualifying, maintaining and/or calibrating equipment strongly preferred.
• Proficient in referencing, researching, reporting, tracking, and monitoring.

Work Hours: 8

Experience in Months: 60

Level of Education: Bachelor Degree

Job application procedure
• Suitably qualified candidates are invited to apply. However, only shortlisted candidates will be contacted.
• Inetersted and qualified? Click here to apply

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