Technical Officer-Laboratory, Dhaka, Bangladesh
Who is USP?
The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 hard-working professionals across five global locations to deliver the mission to build a stronger supply of safe, quality medicines and supplements worldwide.
Brief Job Overview
PQM+ has been providing technical assistance to National Drug Control Laboratory (four laboratories i.e., physiochemical, microbiological, vaccine, and the recently established medical devices testing laboratory within it), Regional/Divisional Laboratory (CDTL), IEDCR, Private sector laboratory (PPRTL) and others.
How will YOU create impact here at USP?
The Technical Officer, Laboratory - is a key technical position for PQM plus program in Bangladesh. The technical officer is a subject matter expert in medical laboratory operations and quality management. The technical officer position will provide cross-cutting laboratory support to country program implementation of the activities of the PQM+ program in Bangladesh. The Technical Officer will work with the scientists and management of the of the PQM+ supported laboratories to provide technical assistance in building their capacity for laboratory testing and QMS in Bangladesh. S/he will engage in providing technical support to the laboratories to achieve or sustain national/international standards toward accreditation (ISO 15189, 15190, and others as applicable). In addition, s/he will also provide other laboratory support assigned by the line manager.
- Assist medical laboratories to comply in international standards and guidelines, including ISO 15189, ISO 15190, ICH, and WHO guidelines.
- Evaluate medical laboratory quality management and technical operations systems to determine strengths and areas for potential improvement.
- Advise on the development and implementation of PQM+ work plan technical activities which allow laboratories to systematically build their capacity and the sustainability of their operations.
- Assist in preparing and addressing Corrective Actions, to include risk assessments and mitigation strategies.
- Provide technical support to selected PQM+ supported laboratory teams on lab functions and increase the laboratory’s capacity to achieve and maintain ISO standards as applicable.
- Train the selected medical labs, on how the standard is used in assessing the competence of medical laboratories.
- Technical support for ensuring laboratory biosafety and biosecurity.
- Arrange awareness sessions on ISO 15189 and 15190 standards for selected medical labs.
- Conduct training as per needs and prepare training reports on PQM+ reporting format.
- Develop/review policies, regulations, guidelines, and SOP’s related to ISO requirements.
- Develop/Review and update protocol and implement instrument and test-related procedures.
- Collect and interpret quantitative/qualitative information, with analytical problem-solving.
- Organize and support SOPs management systems in the selected medical labs to achieve ISO 15189 accreditation.
- Provide support to the selected medical labs for developing documents according to standard requirements.
- Develop and deliver training material related to medical laboratory testing techniques, quality assurance and control.
- Keep abreast of the latest regulatory trends and WHO guidance regarding medical laboratories.
- Collaborate with supported laboratory management, PQM+ country team, PQM+ HQ Technical Team and other implementing partners and stakeholders.
- Prepare monthly and quarterly reports.
- Coordination and collaboration between DGDA & IEDCR to create platform for AMR data sharing for regulatory function.
- Provide support to develop procedures for DGDA and IEDCR to establish AMR data sharing process and quality data analysis.
- Arrange coordination meeting between DGDA & IEDCR for AMR data sharing.
- Workstation: primarily at IEDCR.
Who USP is Looking For?
The Successful Candidate Will Have a Demonstrated Understanding Of Our Mission, Commitment To Excellence Through Inclusive And Equitable Behaviors And Practices, Ability To Quickly Build Credibility With Stakeholders, Along With The Following Competencies And Experience
- Master’s degree in microbiology/Virology or related field of study.
- Minimum 6 (Six) years of practical experience in a reputed medical laboratory or in a Microbiology laboratory of any leading pharmaceutical or non-government health-related technical program management.
- Experience in QMS handling and facing internal/external audit and involving in corrective action management and implementation.
- Experience [3+ years] developing and organizing cell banks, to include cell revival, sub-culture, and cryopreservation of different cell lines.
- Experience evaluating laboratory biosafety and biosecurity requirements.
- Experience drafting, reviewing, and updating policies, regulations, guidelines, documents, protocol (analytical method validation protocol, Equipment performance qualification protocol etc.) and implement and test-related procedures in line with international standards.
- Knowledge and hands on skills related to instrumentation use and maintenance; to include, PCR system, Incubator, Bio-safety Cabinet, inverted microscope, flow cytometry, Gel Doc system, DNA Sequencer, Spectrophotometer, ELISA Reader, Fluorescence Immunoassay Device
- Experience in a similar position for 3-5 years is preferred.
Additional Desired Preferences
- Proof of implementing effective, timely, and quality implementation of donor-funded (particularly USAID-funded) global health or international development projects
- Experience in implementing technical assistance programs in expanding access to global health products and pharmaceuticals.
- Good understanding of and experience working with USAID compliance rules and regulations
- Significant experience working with high-level officials in USAID and country governments.
- Excellent client relationship management skills
- Excellent written and verbal communication skills
- Ability to work in cross-cultural settings.
- Ability to demonstrate the highest degree of ethics and integrity.
- Willingness to travel
Supervisory Responsibilities
Benefits
USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing is protected.
COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired):
As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must be fully vaccinated unless a reasonable accommodation is approved.
Your recruiter will advise accordingly.
USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—from the standards we make to the partnerships and conversations we cultivate. An environment where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP
Job Category: Technical Programs
Job Type: Full-Time
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