Careers in Food and Drug Law

Consumer Safety Officer
US Food and Drug Administration - Office of Regulatory Affairs
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Consumer Safety Officer

US Food and Drug Administration - Office of Regulatory Affairs

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Details
Posted:
April 7, 2021
Location:
United States
Salary:
$46,083 to $59,907
Type:
Full Time - Experienced
Preferred Education:
4 Year Degree

The Direct-Hire positions are in the Food and Drug Administration and are located in the Office of Regulatory Affairs (ORA) office which is the lead office for all agency field activities. ORA inspects regulated products and manufacturers, conducts sample analyses of regulated products and reviews imported products offered for entry into the United States.

**A Recruitment Incentive of $5,000 is authorized.**

Consumer Safety Officer

  • As a Consumer Safety Officer (CSO), you will be responsible for conducting inspections and investigations in an industry regulated by the Food and Drug Administration and submitting written computer-generated reports accompanied by supporting evidence documenting violations of the laws that we enforce.
  • CSOs routinely examine products covering six primary areas: pharmaceuticals, medical devices, human and animal foods, biologics, bioresearch monitoring, and imports to ensure compliance with U.S. law. This includes imported products at ports of entry around the country.
  • FDA works closely with our U.S. Customs and Border Protection counterparts to cover ports of entry along with nine International Mail Facilities (IMF). In some districts, a CSO assigned to import operations may be trained/assigned to one of the United States border locations or IMF.

FDA CSOs add value by:

  • Investigating complaints of injury, illness, or death caused by an FDA-regulated product.
  • Initiating actions against violators.
  • Advising industry, state and local officials and consumers on enforcement policies, methods, and interpretation of regulations.
  • Planning and directing regulatory programs.
  • Developing inspection procedures and techniques.
  • Coordinating the review process of New Drug Applications (NDAs).

Conditions of Employment

  • Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.
  • Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
  • Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
  • FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
  • Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
  • Position requires occasional lifting of heavy objects up to 50 lbs and may require work to be performed in extreme environmental conditions such as dust, cold, hot, noise, etc., for extended periods of time.

Qualifications

The position of Consumer Safety Officer falls under the 0696 occupational series. To qualify for this position at grade GS-9, you must meet the following:

Basic Requirements
Applicants must have successfully completed one of the following (A or B):

A. Bachelor's or graduate/higher level degree in quality assurance or a related degree that included at least 30 semester hours in one or a combination of the following: consumer laws, biological sciences, food science, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, legal investigations, law enforcement, or related scientific fields that provided knowledge directly related to consumer safety officer work.

The 30 semester hours may include up to 8 semester hours in statistics, or course work that included the principles, theory, or practical application of computers or computer programming;

OR

B. Combination of education and experience--courses consisting of at least 30 semester hours in the fields of study described in paragraph A above, plus appropriate experience or additional education.

NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.

Minimum Qualifications

Specialized Experience. Specialized experience is experience that equipped the applicant with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled.

You must possess 1 year of specialized experience equivalent to the GS-7 in the Federal service that includes experience: conducting routine inspections; interpreting and evaluating technical data; developing and drafting reports on technical study findings and compliance documents.

OR

Master's or equivalent graduate degree or two full years of progressively higher level graduate education leading to such a degree in a field related to the position to be filled;

OR

Combination of specialized experience and graduate level education in a field related to the duties of this position that meets 100% of the qualification requirements for this position.

All qualification requirements must be met by 11:59 pm (Eastern Time) on 04/14/2021. If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible or your score may be adjusted to more accurately reflect your skills and abilities. You must continue to meet all requirements through the hiring process.

You may be asked to provide additional information at a later time. All interview requests and selection decisions are at the full discretion of the hiring office.

NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date . To verify your application is complete, log into your USAJOBS account, https://my.usajobs.gov/Account/Login, select the Application Status link and then select the More Information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process.

IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of experience. In addition to describing duties performed, applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information, failure to provide this information may result in disqualification. Applicants are encouraged to use the USAJOBS Resume Builder to develop their federal resume.

NOTES:
12 openings.

Additional Salary Information: $5000 Hiring Bonus has been approved
Internal Number: 597645300
About US Food and Drug Administration - Office of Regulatory Affairs
US Food and Drug Administration - Office of Regulatory Affairs ORA is at the forefront of building a public health safety net for today’s complex, global regulatory environment. ORA professionals work in a range of program areas and locations, with 227 offices and 13 laboratories throughout the United States. As the lead office for all FDA field activities, ORA serves as the eyes and ears of the agency through: Inspections of firms and plants producing FDA-regulated products Investigations of consumer complaints, emergencies and criminal activity Enforcement of FDA regulations Sample collection and analysis Review of imported products ORA is committed to quality and continual improvement, and maintains oversight of the industries FDA regulates, including: Foods and Veterinary Medicine Medical Products Tobacco ORA efforts in these program areas include: Collaborating with all FDA Product Centers and federal, state, local, tribal, territorial and foreign regulatory public health counterparts Implementing new authorities granted by legislation Developing regulatory program standards for quality improvements Establishing safety systems and coordinating emergency communications Risk-based monitoring of imported products
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