Technical Advisor, Laboratory QMS/QC/Metrology
Company: The U.S. Pharmacopeial Convention (USP)
Location: Rockville
Posted on: May 13, 2022
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Job Description:
The U.S. Pharmacopeial Convention (USP) Technical Advisor,
Laboratory QMS/QC/Metrology Rockville , Maryland Apply Now Apply
Now w/ LinkedIn 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.Basic Qualifications--- 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 trainingSkills Sought---
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.Preferred Qualifications--- 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.Supervisory ResponsibilitiesnoneUSP
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 USPThe 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.Equal
Opportunity Employer/Protected Veterans/Individuals with
DisabilitiesThe 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 contractor's legal duty to
furnish information. 41 CFR 60-1.35(c)USP is proud to be an equal
opportunity/affirmative action employer. Employment selection and
related decisions are made without regard to sex, gender identity,
race, age, disability, religion, national origin, color, veteran
status or any other protected class. We are committed to working
with and providing reasonable accommodation to individuals with
disabilities.If, because of a medical condition or disability, you
need a reasonable accommodation for any part of the employment
process, please send an e-mail to humanresources@usp.org or call
(301) 230-3257 and/or 711 for TTD/TTY service.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.Any unsolicited resumes sent to
USP, including unsolicited resumes sent to a USP address, or email
address, directly to USP employees, or to USP's resume database
will be considered USP property. USP will NOT pay a fee for any
placement resulting from the receipt of an unsolicited resume. USP
considers candidates for whom an agency has submitted an
unsolicited resume to have been referred by the agency free of any
charges or fees.We care about candidates! Please take 30 seconds
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Keywords: The U.S. Pharmacopeial Convention (USP), Rockville , Technical Advisor, Laboratory QMS/QC/Metrology, IT / Software / Systems , Rockville, Maryland
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