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Lab Quality Assurance Manager
JOB PURPOSE:
To work with relevant quality staff to develop comprehensive quality programs that will ensure the maintenance of laboratory QMS to internationally recognised GCLP standards. Expansion of the QMS to other areas of the laboratory in order to qualify for GCLP accreditation.
Description:
REPORTS TO: Head of Biosciences
DIRECTLY SUPERVISES: Laboratory Quality Assurance Officer
JOB DIMENSIONS:
To work with relevant quality staff to develop comprehensive quality programs that will ensure the maintenance of laboratory QMS to internationally recognised GCLP standards. Expansion of the QMS to other areas of the laboratory in order to qualify for GCLP accreditation.
KEY RESPONSIBILITIES:
- Manage the laboratory quality team and develop a quality management structure for the laboratory.
- Develop, monitor and implement quality assurance compliance objectives and programs and report on progress/ level of compliance.
- Participate in the development, review, update and implementation of quality policies, procedures and monitoring tools.
- Liaise with managers and operating staff within the laboratories to ensure that QA/QC procedures are continuously monitored with well documented corrective action where appropriate.
- Monitor, collate and analyse adherence, uptake of staff and performance data and charts against defined parameters to identify areas for growth and generate reports.
- Acting as a catalyst for change, being creative in formulating strategies to encourage staff to implement QA/QC processes and improve performance and quality.
- Training, motivating, coaching, and correcting employees to ensure that standards are met.
- Organise internal audits as per identified auditable areas, train internal auditors, co-ordinate internal audits and ensure document all audit findings are documented.
- Liaise with the external auditors, monitors and inspectors in conducting audit activities including scheduling audits, facilitating audits and working with relevant staff to implement actionable areas/findings.
- Maintain laboratory staff training database, identify and coordinate quality related training needs, develop training programs and materials and conduct training.
- Promote quality achievements and performance improvement within and throughout the laboratories.
- Coordinate regular QMS performance meetings with designated personnel from each laboratory discipline to communicate objectives, discuss performance and identify areas of improvement.
- Ensure maintenance and control of laboratory QMS records and documentation.
- Prepare and submit reports as and when required.
- Deputise and fill-in for other quality staff as may be required.
- And any other duties that may be assigned from time to time.
QUALIFICATION:
- Masters degree in Biomedical Sciences or equivalent.
- At least 8 years’ experience working in a medical/ research laboratory with at least 5 years’ experience as a Quality Assurance Officer.
- Professional qualification in laboratory quality assurance/ control
- Training in quality management systems, quality assurance programs or equivalent
- Sound knowledge and understanding of lab QMS’s, GCLPs and other relevant best practices and standards.
COMPETENCIES:
- Strong analytical and follow through ability; attentive to detail.
- Ability to follow laid down processes and procedures.
- Confidentiality and integrity
- Planning and organizational skills
- Excellent interpersonal and communication skills
- Team working and ability to work in a multi-cultural environment.
Clinical Officer-Human Genetic Studies
JOB PURPOSE:
The Clinical Officer in this role will assist in running studies on Sickle cell disease. The post holder conducts daily activities to ensure communication with participants, clinical assessment and care, timely recruitment, data collection, follow up and adherence to study-specific procedures.
Description:
REPORTS TO: PRINCIPAL INVESTIGATOR & PROJECT COORDINATOR
DIRECTLY SUPERVISES: NURSES & FIELD WORKERS.
JOB DIMENSIONS:
The KEMRI-Wellcome Trust Research Programme conducts high quality clinical trials focussing on diseases that present a high burden for developing countries.
We run two major studies: An observational cohort study and a clinical trial, involving children with sickle cell anaemia at the Kilifi county hospital.
The post holder will have a high level of responsibility for ensuring study integrity, adherence to guidelines and standard operation procedures, managing staff and ensuring that the studies run smoothly. The post holder will need to be self-sufficient and be able to work mostly without supervision, often with an unpredictable timescale. The post is mentally demanding, and involves a high level of communication among study team, with other participating study sites, study participants and the wider community.
Staff operating at this grade range contribute to a research team and deal with non-standard work situations more regularly than staff at lower grades and take decisions often relating to the interpretation of standard operating procedures. They are required to provide guidance to team members at lower grades, and also be involved in supervising the work of others. Staff have responsibility for prioritizing their own work and ensuring the necessary equipment/materials are available.
KEY RESPONSIBILITIES:
- Assist in providing SCD clinical services.
- Screen, recruit, enrol and follow up of study participants.
- Provide information, education and support to families or guardians of the research participants.
- Administer or oversee the informed consent process.
- Conduct trial-related assessments and collection of data using case record forms in accordance with Good Clinical Practice (GCP) and protocol.
- Assist with documentation and reporting of serious adverse events and clinical endpoints, including death and prolonged hospitalization.
- Monitor treatment toxicity/side effects and liaise with the clinical care team to initiate changes to treatment as required by the protocol.
- Ensure that the whole team are working according to GCP and research governance standards for clinical trials.
- Help to manage study-specific fieldworkers including planning of field activities.
- Foster good working relations with hospital’s clinical team and be able to contribute to/participate in continuous medical education (CME) activities in paediatric department
- Be required to undertake other duties, which are broadly in line with the above key roles and responsibilities.
- any other duties allocated by the supervisor or PI.
SKILLS AND COMPETENCE:
ESSENTIAL
- Diploma in Clinical Medicine
- Flexible – able to work extra hours when needed
- Able work under stressful environment, self-driven and highly motivated
- Strong interpersonal and communication skills (oral and written)
- Personnel management skills and computer-literate with proficiency in project management tools and Microsoft applications
DESIRABLE
- Prior experience of clinical trials/research work,
- GCP and research ethics training
- Ability to communicate in Giriama added advantage.
PHYSICAL ENVIRONMENT/CONDITIONS:
- Based at the Kilifi County Referal Hospital, Kilifi
- Be available to work flexibly, out of hours as necessary.
- Travel to other trial sites for training.
- Exposure to patients and materials considered infectious and/or biohazards.
Method of Application
Use the link(s) below to apply on company website.