E-DRUG: US Pharmacopeia job opportunity - GMP Specialist
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US Pharmacopeia in Rockville, MD (United States), has the following
position open. To apply for this position, please email your resume to
kjb@usp.org or apply through our website www.usp.org.
Function of the Position: This is a hands-on, non-supervisory position
where the incumbent is a current good manufacturing practice (cGMP)
specialist who understands the standards and principles of auditing
manufacturing facilities for cGMP compliance. This individual must be
capable of analyzing all elements of a quality system and judging its
degree of compliance with the criteria of quality management, evaluation
and control systems. The individual will be expected support dossier
reviews of companies applying for World Health Organization (WHO)
prequalification. He/she assists the Senior Program Advisor in the
evaluation of cGMP, QA, and manufacturing records received from
manufacturers.
Roles and Responsibilities:
Conducts final evaluation of documents and data received from
pharmaceutical, manufacturers to ensure compliance with cGMP principles;
Works with the Promoting the Quality of Medicines (PQM) staff to
expedite and coordinate dossier reviews and possible site visits and
audits;
Works with PQM management to develop appropriate guidelines for
conducting cGMP auditing of manufacturing firms;
Revises, establishes, and provides guidelines for SOPs pertaining to
cGMP and QA compliance;
Assists or conducts GMP training as needed.
Minimum Requirements: Bachelor's degree in Chemistry or other related
field with minimum of 5 years experience in conducting cGMP audit of
pharmaceutical and/or generic ANDA experience from pharmaceutical
development to filing or experience in an Analytical Quality Control
environment. An equivalent combination of education and experience may
be considered. Must have some industry experience in the establishment
of quality system compliance within pharmaceutical manufacturing
companies.
Knowledge, Skills, Abilities, Training and Experience: Knowledge in GMP
drug development to commercialization. Understanding of generic
pharmaceuticals, including testing and production. Excellent verbal,
written and presentation skills; grant writing experience helpful.
Ability to create a team environment among staff located globally.
Ability to travel at least 10% of the time.
Supervisory Requirements: None
Status: Exempt
Local candidates strongly preferred.
We are proud to be an AA/EEO employer M/F/D/V. Women, minorities,
veterans, and disabled persons are encouraged to apply. If you are
interested in applying for employment with the United States
Pharmacopeia and need special assistance or an accommodation to apply
for a posted position, please contact our Human Resources department at
humanresources@usp.org.
Kim Beachley
Employment Specialist
U.S. Pharmacopeial Convention
12601 Twinbrook Parkway
Rockville, MD 20852-1790
301-230-6328 Office
301-816-8332 Fax
301-704-1321 Mobile
www.usp.jobs ( http://www.usp.jobs/ )
"Kimberly Beachley" <kjb@usp.org>