Technical Advisor, Laboratory QMS/QC/Metrology
Summary of the Position
The Technical Advisor (TA), Laboratory QMS/QC/Metrology is a non-supervisory role reporting to the Senior Technical Advisor, Laboratory QMS/QA/QC of the Promoting the Quality of Medicines Plus (PQM+) program within the Global Health and Manufacturing Services Division. The incumbent in this role liaises and collaborates with headquarter senior technical advisors, regional technical officers, project managers and chiefs of party to ensure the successful implementation of program objectives. s/he will provide technical expertise and guidance to designated countries within the PQM+ portfolio in the areas of quality management and quality control of medicine laboratory testing operations and metrology. The incumbent is expected to develop, operationalize, and improve laboratory analytical capabilities and equipment preventative maintenance and calibration programs to ensure compliance with international standards and guidelines. Additionally, s/he will apply knowledge of analytical testing methodologies and measurement science to create and deliver training on compendial testing, instrument/equipment qualification, calibration, and preventative maintenance as well as general quality processes.
Roles and Responsibilities
• Assist national quality control laboratories to comply with equipment requirements defined in international standards and guidelines; to include ISO/IEC 17025, ISO 15189 and WHO Prequalification
• Develop and evaluate laboratory preventative maintenance and calibration programs to determine strengths and areas for potential improvement.
• Prepare development plans to address gaps in laboratory personnel, equipment, and processes
• Develop calibration procedures and methods, according to detailed specifications, and manufacturers requirement
• Analyze measurement data to identify irregularities, trends and/or to predict future values
• Develop and deliver technical scientific training courses according to the needs of the different laboratories; pharmaceuticals, biopharmaceuticals, and clinical/medical
• Assist with standard operating procedure optimization
• Partner with Senior Technical Advisor on future special assignments.
• BS Chemistry or Analytical Chemistry, or related field, with a minimum of 5-years’ experience in operating and maintaining analytical laboratory equipment
• Three (3) years’ experience with instrumentation used in pharmaceutical, medical device, and microbiology laboratories.
• Three (3) years interfacing with internal or external clients or stakeholders
• At least one (1) year demonstrated knowledge of ISO 9001 and ISO/IEC 17025;
• Six months experience developing and/or conducting training
• Working knowledge and understanding of laboratory quality elements, quality control measures, and key aspects of medicines quality testing.
• Requires excellent written and verbal communication skills and the ability to communicate science/technical information to those without a background in science.
• Familiar with and demonstrates knowledge of GMP/GXP/GLP and the importance of data integrity
• Deep domain knowledge and understanding of analytical concepts, principles, and theories related to chemical and microbiological analyses
• Strong ability to troubleshoot and problem solve and assess risks associated with a decision
• Ability and desire to influence without direct authority as well as work well with diverse employees and customers in a cooperative and friendly manner
• Ability and willing to travel 25%-30% internationally.
• Three (3) years hands on experience ISO.
• Prior experience in a government funded programs, such as USAID.
• Intermediate computer skills: office, excel, PowerPoint, SharePoint
• Strong knowledge of key public health issues and trends, including in TB, HIV/ AIDS, NTD, MNCH, Malaria and AMR
• Results driven with demonstrated successful outcomes.
• Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner.
• Demonstrated experience designing project and developing technical components of proposals for donor funded programs (i.e.: USAID, GFATM, Gates Foundation, UNITAID, WHO, etc.).
• Experience working internationally for a global health organization in low- and middle-income countries.
USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing are protected.
The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities. 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.
The following COVID-19 provisions will apply to selected candidate(s) hired:
As a condition of employment with United States Pharmacopeial Convention’s (USP) duty to provide and maintain a workplace that is free of known hazards, all employees and contingent staff hired after July 1st, 2021 are required to be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.