Laboratory Quality Assurance Officer

Position: Laboratory Quality Assurance Officer (1 post)

Reports To:  Laboratory Manager

Work Station: Bagamoyo

Apply By: December 26, 2023

Institute Overview 

Ifakara Health Institute (IHI) is a leading research organization in Africa with a strong track record in developing, testing and validating innovations for health. Driven by a core strategic mandate for research, training and services, the Institute’s work now spans a wide spectrum, covering biomedical and ecological sciences, intervention studies, health-systems research, service delivery and policy translation. 

Position Summary 

Ifakara Health Institute seeks a qualified and experienced Lab Quality Assurance Officer who will be responsible for ensuring the laboratory's compliance with quality management systems, GCP, GCLP, ISO 15189, regulatory requirements, Study protocols and Standard Procedures (SOP). The role also involves the development, implementation, and maintenance of quality assurance processes and procedures to uphold the highest standards of accuracy, precision, and reliability in laboratory testing and operations and meet customer satisfaction.

Duties and Responsibilities

1. Quality Management System (QMS)

• Develop, implement, and maintain the laboratory's quality management system in alignment with ISO 15189 or other relevant standards.
• Ensure that quality objectives are defined and monitored regularly.

2.    Policy and Procedure Development

• Collaborate with lab management and personnel to establish, review, and revise laboratory policies, procedures, and protocols.
• Ensure that all laboratory practices adhere to established quality standards.

3.    Documentation and Record Keeping

• Oversee the documentation and record-keeping processes to ensure compliance with regulatory and accreditation requirements.
• Conduct regular audits of laboratory documentation and records.

4.    Internal Audits and Inspections

• Plan and conduct internal audits to assess the effectiveness of quality assurance processes and identify areas for improvement.
• Develop corrective and preventive action (CAPA) plans in response to audit findings.

5.    Compliance and Accreditation

• Monitor and maintain compliance with relevant regulatory agencies and accreditation bodies.
• Prepare and coordinate laboratory accreditation and certification processes.

6.    Training and Education

• Develop and deliver quality assurance training programs for laboratory staff to enhance awareness and compliance with quality standards.
• Keep staff updated on changes in regulations and standards.

7.    Risk Assessment and Management

• Conduct risk assessments and assist in the development of risk management strategies to mitigate potential issues affecting laboratory operations.
• Address and document deviations and non-conformities as they arise.

8.    Continuous Improvement

• Identify opportunities for process improvement and lead quality improvement initiatives.
• Analyze data to monitor trends and recommend corrective actions.
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9.    Supplier and Vendor Quality Assessment

• Evaluate and maintain a list of approved suppliers and vendors, ensuring their adherence to quality standards.
• Collaborate with procurement to manage supplier relationships.

10.  Communication and Reporting

• Provide regular reports and updates to laboratory management on quality assurance activities, issues, and achievements.
• Serve as a point of contact for external auditors and inspectors.

11.  Other duties

• Review and authorize Lab results.
• Be accountable for Lab services costs by raising invoices.
• Perform any other job assigned by a Supervisor that seems relevant.

Qualification and Experience

• A Bachelor's degree in Medical Laboratory or relevant equivalent education and experience.
• Five Years of working experience in Lab Quality Assurance.
• Certification in quality management (e.g., Certified Quality Manager, ASQ) preferred.
• Medical Lab registration.
• In-depth knowledge of quality management principles, standards (ISO 15189:2022 requirements, CLIA), and regulatory requirements.
• Detail-oriented with a commitment to accuracy and compliance.
• Proficiency in using quality management software and tools.
• Proficiency in laboratory techniques and instrumentation.
• Commitment to maintaining confidentiality, working Impartial and ethical standards.
• Ability to work independently and under supervision.

Skills and Competencies

• Auditing Skills.
• Skills in Data analysis with different statistical methods and software.
• Computer skills.
• Strong attention to detail.
• Ability to work under pressure.
• Report writing.
• Planning skills.
• Budgeting and Finance skills.
• Leadership skills.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal abilities.
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• Adhere to IHI core values (Integrity, Initiative, Equity, Excellence, Accountability).

Remuneration  

An attractive and competitive remuneration package will be offered to successful candidates as per IHI salary scales.

Equal Opportunity

IHI is an equal opportunity employer. We prohibit intentional biases or discrimination and harassment of any kind at the work place and during recruitment. All employment decisions are based solely on job requirements and individual qualifications, and our recruitment process is governed by the labour laws of Tanzania.

Mode of Application

All candidates who meet the above job requirements should send their application letters together with their detailed curriculum vitae (CVs) showing contact addresses including email, telephone/cell phone numbers and copies of academic and professional certificates to the email address below. 

The deadline for this application is 17:00hrs on Tuesday, December 26^th, 2023. All e-mail application subject lines should include: LABORATORY QUALITY ASSURANCE OFFICER – LABORATORY UNIT. Only shortlisted applicants will be contacted for an interview

Human Resources Manager 

IFAKARA HEALTH INSTITUTE

#5 Ifakara Street Plot 463 Mikocheni  

P.O. Box 78,373 

Dar es Salaam, Tanzania

Email: recruitment@ihi.or.tz