Overall Purpose of the Position:
The role of Biological Sample Management Officer plays a crucial role in ensuring the integrity and quality of sample management processes within clinical trials and non-clinical study support. The incumbent will oversee the pre-analytical phase of sample processing, ensuring adherence to Good Clinical Laboratory Practice (GCLP) guidelines and implementing robust quality control procedures. Additionally, the role involves providing support for study start-up activities and driving continuous improvement initiatives to optimize sample processing workflows.
Key Performance Areas (KPAs) & Responsibilities include, but not limited to:
Quality Control Supervision:
• Providing high-end quality control guidance and monitoring over all aspects of the pre-analytical phase of sample management and processing, ensuring sample integrity covering the entire life span of each sample, including collection in the clinical / non-clinical testing site, transportation, analysis, storage, and disposal.
• Developing, implementing and maintaining quality control procedures for the pre-analytical sample processing
• Establishing standards and protocols for specimen collection, labelling, handling and storage.
• Monitoring adherence to quality control procedures and identify areas for improvement.
Compliance Management:
• Ensuring adherence to Good Clinical Laboratory Practice (GCLP) regulations, project specific manuals and protocols, and other relevant quality standards in all aspects of sample processing.
• Reporting of deviations, assisting in compiling corrective and preventative action reports and supporting the implementation and training on preventative measures, where necessary.
Process Optimisation:
• Identifying opportunities for improvement in sample processing workflows and implementing effective solutions and recommendations to enhance efficiency and accuracy.
• Implementing efficient processes and workflow improvements to enhance productivity and reduce turnaround times.
• Study start up: Assisting with study start up by setting up safety laboratory requirements, reviewing and approving laboratory manuals / documents, identifying and supporting in the procurement of consumables and supplies needed as well as performing any other related functions necessary to set up project-specific sample collection at a site
Staff Training and Development:
• Training and mentoring sample processing staff on best practices in sample processing, quality control procedures, and compliance requirements.
• Attending site initiation visits to present and facilitate training when necessary.
• Conducting competency training and tests.
• Liaising and supporting site management where appropriate corrective action may need to be taken.
Quality System Implementation:
• Being knowledgeable on best practices and new developments in sample handling and processing to maintain and enhance sample integrity.
• Developing and implementing a comprehensive quality system for sample processing, covering both technical and human resources aspects, to deliver high-quality service consistently.
• Working closely with quality assurance and site teams to address any quality issues to prevent recurrence and with external and internal audits.
Documentation and Reporting:
• Maintaining accurate records of sample processing activities, quality control measures, and compliance documentation in line with GCP and GCLP.
• Preparing reports on quality metrics and performance indicators.
Risk Management:
• Identifying potential risks in sample processing activities and developing strategies to mitigate them effectively.
• Investigating incidents of sample processing errors and develop corrective and preventive actions.
• Supporting the implementation of risk mitigation initiatives where appropriate and required.
Collaboration:
• Collaborating with cross-functional teams, including laboratory personnel, project managers, and quality assurance professionals, to ensure seamless integration of quality processes across the organisation.
Ideal Requirements
• Relevant Science qualification (BSC / Biotechnology / Medical Technologist – Clinical Pathology)
• Minimum of 2 years of experience in a laboratory setting, preferably with a focus on sample processing and quality control (Advantageous)
• Demonstrated experience in developing and implementing quality systems and process improvement initiatives (Preferred)
• Thorough understanding of Good Clinical Laboratory Practice (GCLP) guidelines and other relevant quality standards
• Valid Good Clinical Practice (GCP) certificate
• Valid Driver's Licence and must be prepared to travel between sites (Cape Town based)
Key Personal Inherent Characteristics
• Excellent problem-solving skills and the ability to provide effective recommendations for optimizing sample processing workflows.
• Proven leadership abilities, with experience in supervising and mentoring laboratory staff.
• Strong effective communication and interpersonal skills, with the ability to collaborate meaningfully with cross-functional teams.
• Detail-oriented with a commitment to maintaining high standards of quality and compliance.
Details: Area: Parow, Cape Town
Contract Type: 24 Months Fixed Term Contract
Applications Close: 17 May 2024
Please indicate in your application that you are applying for the above-mentioned position.
If you have not received a response within one month, your application was most likely unsuccessful.
TASK reserves the right to withdraw this advertisement and not fill the above-mentioned vacancy at any stage during the recruitment process.
Meeting our employment equity goals will be acknowledged during the recruitment process
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