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U.S. Department of Health and Human Services

About FDA

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Interdisciplinary Scientist – ORA

 

 
Description of Duties
  • Plan, conduct, and direct highly technical, complex inspections related to production, control, testing and processing human or veterinary pharmaceutical products, determine required course of action and level of investigative efforts required.
  • Evaluate drug (human or veterinary) manufacturing firms for compliance with Current Good Manufacturing Practices (CGMP), and document evidence of violations.
  • Recommend regulatory and/or administrative corrective actions.
  • Interacts with officials of regulated industry and foreign governments.
  • Serve as an advisor and liaison for drug programs to regulated industries, State agencies, and other Federal agencies and Agency management.
  • Advises FDA on new advances in technology related to drug products, new programs, laws and regulations, significant court decisions, and any new trends or scientific findings involving drug products.
  • Meet with hostile or uncooperative industry representatives to exchange information and to provide advice and guidance regarding those aspects of the application, notice, amendment, supplements or report which fall within area of review with emphasis on deficiencies.  (Interaction requires considerable tact and firmness to obtain needed information regarding submissions).
  • Perform investigations involving complaints or injury/death.
  • Document inspection findings in prescribed written format according to FDA policies and guidelines.
  • Maintain a working knowledge and awareness of the Current Good Manufacturing Practices objectives and exercise analytical judgment to anticipate potential problems.
 
Qualifications
Applicants must have the basic requirements (for the desired position title) AND the specialized experience as described below.
 
Basic Requirements For Microbiologist:
A. Possess a degree in microbiology, biology, chemistry, or basic medical science that included at least 20 semester hours in microbiology or other subjects related to the study of microorganisms, and 20 semester hours in the physical and mathematical sciences combining course work in organic chemistry or biochemistry, physics, and college algebra, or their equivalent.
OR
B. Possess courses equivalent to a major as shown in A above plus additional education or appropriate experience.
Basic Requirements For Pharmacist:
Possession of a four-year bachelor's degree in pharmacy recognized by the American Council on Pharmaceutical Education (must submit transcript at time of application submittal); AND Possess a license to practice pharmacy in a State, territory of the United States, or the District of Columbia (must submit license at time of application submittal); AND Applicants must be able to distinguish basic colors.
(You must submit a copy of your license along with your application package).
  
Basic Requirements for a Chemist:
A. Possess a four year degree in physical sciences, life sciences, or engineering that included 30 semester hours in chemistry, supplemented by course work in mathematics through differential and integral calculus, and at least 6 semester hours of physics.
OR
B.  Possess a combination of education and experience -- course work equivalent to a major as shown in A above, including at least 30 semester hours in chemistry, supplemented by mathematics through differential and integral calculus, and at least 6 semester hours of physics, plus appropriate experience or additional education.
Specialized Experience
At least one year of specialized experience, equivalent to the GS-12 grade level in the Federal service, developing and implementing strategies to inspect or monitor and evaluate drug manufacturing operations and control systems; providing advice and guidance on scientific and regulatory drug standards, policies and problems involving manufacturing of pharmaceuticals (human or veterinary); investigating and inspecting domestic establishments for drug compliance, and is capable of or has experience conducting foreign drug inspections; providing training to internal and/or external personnel on scientific matters, and investigation issues, policies and regulations.Time-in-Grade Requirements:   Under competitive merit promotion procedures, any individual who is currently holding, or who has held within the previous 52 weeks, a General Schedule position under a non-temporary appointment in the competitive or excepted service, must meet "time-in-grade" requirements (have served 52 weeks at the next lower grade of the grade for which you are applying). Time-In-Grade requirements also apply to current employees applying for a Veterans Employment Opportunities Act of 1998 (VEOA) appointment. NOTE: You must provide a copy of a recent SF-50, "Notice of Personnel Action" that indicates proof of status and time-in-grade eligibility. The SF-50 must include your position, title, series, grade, step, tenure, type of service (Competitive or Excepted) and career status (career or career-conditional).
 
Geographical Locations
Many vacancies in the following location: Location Negotiable After Selection, United States