Technical Advisor

1 month ago

Rockville, Maryland, United States United States Pharmacopeia Full time

Description

Who is USP?

The U.S. Pharmacopeial Convention (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 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.

At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity,

Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare.

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 workan environment where every employee feels fully empowered and valued irrespective of, but not limited to, 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.

Who is USP Looking For?

Job 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

Job Description:

Employer will accept a bachelors 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:

Analyzing laboratory quality elements, applying quality control measures, and implying key aspects of medicines quality testing.

Presenting and preparing scientific and technical information to wide ranges of audiences.

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

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

Applying analytical concepts, principles, and theories related to chemical and microbiological laboratory analyses.

Utilizing common laboratory instruments used in pharmaceutical, medical device, and microbiology settings.

Troubleshooting laboratory equipment used for quality control of medicines.

Problem solving in subjects related to quality assurance of medical products.

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

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 Instructions: Please apply online at Refer to Job code \#TA/

Additional Desired Preferences

They will also possess a high level of attention to detail, organization skills, and time management.

Ability to communicate effectively with internal and external customers necessary.

Sense of urgency and sound judgment needed.

Knowledge of DOT and IATA shipping guidelines preferred.

Forklift and electric pallet jack certification.

Supervisory Responsibilities

None.

Benefits

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.

About USP

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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information. 41 CFR c)

Job Category Technical Programs

Job Type Full-Time

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