Employer: The U.S. Pharmacopeial Convention 

Job Title: Technical Advisor (Multiple Openings)

Job Code: #TA/20421.56.4

Job Location: 12601 Twinbrook Parkway, Rockville, MD, 20852

Job Type: Full Time 

Duties: 

Assist national medicine quality control laboratories of national medicine regulatory authorities in low- and middle-income countries (LMICs) to comply with equipment requirements defined in international standards and guidelines such as ISO/IEC 17025, ISO 15189 and WHO Prequalification. Develop and evaluate laboratory equipment 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 laboratory equipment calibration procedures and methods, according to detailed specifications, and manufacturer requirements. Analyze measurement data to identify irregularities, trends, and predict future values. Develop and deliver technical scientific training courses according to the needs of the different laboratories, pharmaceuticals, biopharmaceuticals, and clinical/medical industries in LMICs. Assist with development of policies, guidelines, standard operating procedures, and protocols to ensure quality and optimization of national quality laboratory services in LMICs. Analyze and execute plans to strengthen the existing Quality Control systems of national laboratories in LMICs. Telecommuting benefits available.

Requirements: 

Employer will accept a Bachelor's degree in Chemistry, Environmental Chemistry or related field, followed by 48 months of experience in job offered or in a Technical Advisor-related occupation. 

Position requires 48 months of experience in the following: 

1) Analyzing laboratory quality elements, applying quality control measures, and implying key aspects of medicines quality testing;

2) Presenting and preparing scientific and technical information to wide ranges of audiences;  

3) Implementing Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) and data integrity; 

4) Executing and maintaining compliance to ISO 9001, ISO/IEC 17025; and WHO pre-qualification; 

5) Applying analytical concepts, principles, and theories related to chemical and microbiological laboratory analyses; 

6) Utilizing common laboratory instruments used in pharmaceutical, medical device, and microbiology settings;

7) Troubleshooting laboratory equipment used for quality control of medicines; 

8) Problem solving in subjects related to quality assurance of medical products; 

9) Assessing risks associated with the sustainability of the quality management system of national medicine quality control laboratories in low- and middle-income countries; and 

10) Designing project and developing technical components of proposals for donor funded programs such as GFATM, Gates Foundation, UNITAID, or WHO.

Position requires travel up to 30% internationally. 

Contact: Please apply online at https://usp.jobs/ Refer to Job code #TA/20421.56.4.