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Consumer Safety Officer

Department of Health and Human Services
Food and Drug Administration
Office of Regulatory Affairs (ORA), Office of Medical Products and Tobacco Operations (OMPTO)
This job announcement has closed

Summary

This position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Office of Global Regulatory Operations and Policy (OGROP), Office of Regulatory Affairs (ORA), Office of Biological Products Operations (OBPO). The position performs a variety of duties to carry out, administer or advise on work concerned with assuring the quality of work transactions, business processes and delivery of services needed to carry out programs and functions.

Overview

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Reviewing applications
Open & closing dates
09/24/2024 to 09/29/2024
This job will close when we have received 100 applications which may be sooner than the closing date. Learn more
Salary
$88,520 to - $115,079 per year

This is a remote position. Therefore, the salary listed is at the base level. The geographic locality pay will be determined at the time of selection.

Pay scale & grade
GS 13
Location
1 vacancy in the following location:
Anywhere in the U.S. (remote job)
Remote job
Yes
Telework eligible
Not applicable, this is a remote position.
Travel Required
25% or less - You may be expected to travel for this position.
Relocation expenses reimbursed
No
Appointment type
Permanent
Work schedule
Full-time
Service
Competitive
Promotion potential
None
Job family (Series)
Supervisory status
No
Security clearance
Other
Drug test
No
Position sensitivity and risk
Moderate Risk (MR)
Trust determination process
Financial disclosure
No
Bargaining unit status
No
Announcement number
FDA-ORA-24-IMP-12542791-PE
Control number
810676900

This job is open to

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Clarification from the agency

Open to current permanent employees of the Food and Drug Administration (FDA) serving on career or career-conditional appointments; Public Health Service (PHS) Commissioned Corps Officers employed by FDA; current FDA employees eligible for appointment under Schedule A (individuals with disabilities); and Career Transition Assistance Plan (CTAP) eligibles.

Duties

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  • Develops programs to ensure that quality control/assurance programs provisions are planned, developed, and implemented to identify, prevent, and correct unsatisfactory conditions and elements which influence the regulatory correctness.
  • Establishes quality program management strategies and techniques to fit operations, culture and interests of headquarters management and staff.
  • Operates the quality systems program and may provide testimonial information to legal officials as to the work of FDA in congressional inquiries.
  • Develops policy guidance, motivational materials, and information to facilitate participation in important program initiatives in accordance with the ORA Quality Manual, ISO standards, and ASQ guidelines.
  • Designs studies, training programs and strategies for identifying opportunities to improve customer service and process quality.
  • Provides direction and counsel to OBPO Management and officials in the implementation of policies, and operational guidelines that form the framework for quality systems management of OBPO.
  • Coordinates, interprets, and evaluates OBPO’s overall efforts.

Requirements

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Conditions of employment

  • Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.
  • 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.
  • Selective Service Registration: All applicants born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption. Visit www.SSS.gov for more info.
  • 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.
  • Time-in-Grade Requirement: If you are applying as a current Federal employee, you must meet the time-in-grade requirements described in the Qualifications section, generally, 52-weeks of comparable experience at the next lowest grade.
  • 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.
  • You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and qualifications attained by this date will be considered. You must continue to meet all requirements through the hiring process.
  • 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.
  • Additional selections may be made from this vacancy, within the same geographical area, by other organizational elements from within FDA, through shared corporate recruiting activities.
  • CERTIFICATION: ASQ (American Society of Quality) certification within one year of performing duties is required.

Qualifications

The position of Consumer Safety Officer falls within the 0696 occupational series. To qualify for this position at grade GS-13, you must meet Time-in-Grade requirements by 11:59 pm EST on 10/02/2024.

Time-in-Grade: Any individual who is currently holding, or has held within the previous 52 weeks, a General Schedule position under non-temporary appointment in the competitive or excepted service, must meet time-in-grade requirements (must have served 52 weeks at the next lower grade or equivalent in the Federal service). Time-in-grade requirements must be met by the closing date of this announcement.

GS-13: Applicants must have 52 weeks at the GS-12 or higher.

BASIC QUALIFICATION: This position requires a degree or completion of specific courses in order to meet the basic education requirement. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. Your transcript(s) must clearly demonstrate the course(s) listed in the Basic Qualification requirement section. If the transcript(s) does not clearly demonstrate this, you must submit a copy of the course description and/or other documentation demonstrating that the courses are equivalent. Degree requirements must be met by the closing date of this job announcement and your transcript(s) submitted must reflect this. If you are selected for the position, an official transcript sent directly from your educational institution will be required for verification prior to appointment.

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.

SPECIALIZED EXPERIENCE: Experience directly related to the position to be filled which has 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, and can be demonstrated thorough knowledge of science, laws and regulations of the Agency.

GS-13: Applicants must have one year of specialized experience equivalent to the GS-12 grade level In the Federal service which includes investigating and analyzing quality trends or conditions and initiate corrective action for programs effectiveness; providing direction in the implementation of policies and operational guidelines that form the framework for quality systems management; and performing audits and assessments of a program's processes and services.

In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above.

PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.

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://secure.login.gov/ 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.

Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community, student, social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.

You must submit supporting documentation to verify your eligibility to apply for this vacancy.
For internal applicants an SF-50 will be required. If Educational requirements are listed, you must submit a Transcript, even if you occupy the series/grade in question.
See the Required Documents section for full details...

Education

NOTE: There is no education substitution for experience at the GS-13 grade level.

TRANSCRIPTS:
Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements.

Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.

Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access.

See the Application Manager Documentation for tips on submitting your paper-based documents.


FOREIGN EDUCATION
Applicants using part, or all of their education completed outside of the U.S. to meet the qualification requirements, must have their foreign education evaluated by an accredited organization to ensure that the foreign education is comparable to education received in accredited educational institutions in the U.S. We will only accept the completed foreign credential evaluation.

To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery. Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded.

Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below:

  1. National Association of Credential Evaluation Services (NACES)
  2. Association of International Credentials Evaluators (AICE)
Credential evaluations are not free, and applicants are responsible for the cost of the selected service.
For more information about this requirement, please visit the https://sites.ed.gov/international/recognition-of-foreign-qualifications/

Additional information

For some advertisements, the Food & Drug Administration receives hundreds, even thousands, of applications from job-seekers. Because of this high level of interest, FDA reserves the option of setting an application number limit.

When an application limit is set, USAJOBS will close the vacancy at 11:59 pm Eastern Time on either:
(A) the day the limit is reached,
-OR-
(B) the pre-defined closing date of 10/02/2024, whichever comes first. If the limit is reached before 11:59 pm ET, all applications in excess of the limit will continue to be accepted until 11:59 pm ET.

The application limit for this advertisement, if applicable, is: 100.

For more information about announcement closing, see: https://www.usajobs.gov/Help/faq/job-announcement/expiration/

ADDITIONAL CONDITIONS OF EMPLOYMENT:

  • Pre-employment physical required: No
  • Drug testing required: No
  • License required: Yes, valid driver's license
  • Mobility agreement required: No
  • Immunization required: No
  • Bargaining Unit: No
  • If you are serving, or have served in the last 5 years (from 10/02/2024) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. Political Appointees FAQ - OPM
  • Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc. This position may require financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For more information please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.

Applicants selected for this position will be subject to reasonable suspicion and post-accident drug testing upon hiring. To demonstrate commitment to the HHS goal of a drug-free workplace and to set an example for other Federal employees, employees not in a testing designated position may volunteer for unannounced random testing by notifying their Drug-free Federal Workplace Program Point of Contact upon hiring.

All requirements must be met by the closing date of this announcement (10/02/2024); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the hiring process.

How you will be evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

Once the job opportunity announcement closes (at 11:59 pm Eastern Time on 10/02/2024), a review of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for this internal position. Eligible internal candidates will be referred to the hiring official for consideration.

If you are referred to the hiring manager for consideration, you may be further evaluated based on an interview; review of requested work samples, writing samples, most recent performance evaluation(s), or professional references; or results of an oral presentation or work-related test. Failure to comply with any of the additional assessment requirements will result in removal from further consideration. These assessment methods/tools may also be listed under Key Requirements.

Please follow all instructions carefully. Errors or omissions may affect your eligibility.

Basis of Rating: Best qualified competitive merit promotion candidates and all qualified noncompetitive candidates will be referred to the hiring manager for consideration.

Career Transition Assistance Program (CTAP): Well-Qualified is defined as an applicant who meets the qualification standards and eligibility requirements for the position, including minimum educational and experience requirements; any medical qualifications and suitability; is able to perform the essential duties of the position, with or without reasonable accommodation; meets any applicable selective placement factors) for the position (such as the ability to speak a specific language or any other factor required immediately upon hire); and is able to satisfactorily perform the duties of the position upon entry. To be well-qualified and exercise selection priority for this vacancy, surplus or displaced Federal employees must be rated at 85.0 or above on the rating criteria for this position. Learn more on the USAJOBS Career Transition Assistance Site.

Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You do not have to respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of the Competencies/KSA's.

  1. Quality Management
  2. Written Communication
  3. Oral Communication
To preview the application questionnaire, click the link below.

https://apply.usastaffing.gov/ViewQuestionnaire/12542791

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