Summary
This position is located in the Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Office of Compliance and Biologics Quality (OCBQ), which is responsible for reviewing and evaluating administrative action recommendations including suspension, revocation, and denial of license.
Only the first 100 candidates who apply to this announcement will be considered for this position.
This job is open to

• Career transition (CTAP, ICTAP, RPL)
  Federal employees who meet the definition of a "surplus" or "displaced" employee.
• Federal employees - Competitive service
  Current or former competitive service federal employees.
• Federal employees - Excepted service
  Current excepted service federal employees.
• Individuals with disabilities
• Land & base management
  Certain current or former term or temporary federal employees of a land or base management agency.
• Military spouses
• Peace Corps & AmeriCorps Vista
• Veterans

Clarification from the agency
Current permanent competitive service Federal employees; excepted service, Federal reinstatement eligibility; Previous career/career-conditional appointments; displaced Federal employees under the Career Transition Assistance Plan (CTAP) and the Interagency Career Transition Assistance Plan (ICTAP); VEOA who are veteran preference eligible separated under honorable conditions after 3 years or more; Military Spouses; PHS Commissioned Corps Officers; and individuals with disabilities.
Duties

• Notifies the district when regulatory action is not documented with reasons thereof.
• Analyzes the inquiry, provides technical expertise, and obtains salient facts from technical and legal material available.
• Develops enforcement standards for direct reference authority for the issuance of warning letters and reviews and evaluates recommendations for the issuance of warning letters for which direct reference authority had not been granted.
• Recommends transmissions of the agency's decision regarding judicial actions to the office for initiation of court proceedings or authorizes the appropriate field office to issue a citation for hearing.
• Inspect and report on the condition of licensed biological manufacturers, a substantial number of which involve unusual and/or intricate manufacturing processes and quality controls, and/or a wide variety of biological products.
• Reviews inspection reports submitted by field investigators to determine compliance with applicable laws and regulations, and the need for follow-up investigation by the field.
• Develops strategies for consideration of the agency position in response to requests for advisory opinions for the regulated industry, Congress, department officials, etc.
• Reviews and analyzes reports submitted by manufacturers of blood and blood products, and human cells, tissue, or cellular or tissue-based products (HCT/Ps) pertaining to voluntary recalls.

Requirements
Conditions of Employment

• Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.
• 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.
• 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.
• 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 requirementsdescribed in the Qualifications section, generally, 52-weeks of comparable experience at the next lowest grade.
• 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.
• 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.
• 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.

Qualifications
The position of Consumer Safety Officer falls within the 0696 occupational series. To qualify for this position at grade GS- 12/13, you must meet Time-in-Grade requirements by 11:59 pm EST on 07/05/2024.
Basic Requirements:
A. 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. Qualifying experience involves enforcing laws and regulations to protect consumers from foods, drugs, cosmetics, fabrics, toys, equipment, and household products that are defective, dangerous, impure, unwholesome, ineffective, or improperly or deceptively labeled or packaged.
Minimum Qualifications: 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. The specialized experience must demonstrate one year of full-time work experience , or the equivalent if part-time (for example, an employee working 20 hours per week for a 12-month period should be credited with 6 months of experience.) Experience may have been obtained in either the federal service or its equivalent with state or local government, the private sector, or nongovernmental organizations.
Specialized experience for GS-12 : You must have one (1) year of specialized experience equivalent to at least the GS-11, in the Federal service, which includes: (1) Reviewing and evaluating administrative action recommendations including suspension, revocation, and denial of license; OR (2) Reviewing recommended civil and criminal actions, including seizure, injunction, and prosecution.
-OR-
A combination of specialized experience and education as described above that, when combined, equal 100% of the total requirement.
Specialized experience for GS-13 : You must have one (1) year of specialized experience equivalent to at least the GS-12, in the Federal service, which includes: (1) Performing at an expert level of technical competence in the area of blood, plasma, HCT/P (Human Cells, Tissues, and Cellular and Tissue-Based Products), and medical device manufacturing practices; OR (2) Preparing documents required for enforcement actions and manages cases after actions are taken; OR (3) Developing enforcement standards for direct reference authority to the office for issuance of warning letters, and reviews and evaluates recommendations for the issuance of warning letters; OR (4) Planning and implementing educational programs for the agency's staff regarding evidence development in support of administrative and legal actions.
-OR-
A combination of specialized experience and education as described above that, when combined, equal 100% of the total requirement.
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.
If you are applying based on some other qualifying eligibility (i.e. you are not applying as a current Federal employee), you must meet the specific requirements of the eligibility you are claiming, and must have sufficient past experience to demonstrate that you are minimally qualified for this position. See Unique Hiring Paths on USAJOBS for more information about various ways you may be eligible to apply!
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://my.usajobs.gov/Account/Login, select the Application Status link and then select the M ore 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.
To return to an incomplete application , log into your USAJOBS account and click Update Application in the vacancy announcement. You must re-select your resume and/or other documents from your USAJOBS account or your application will be incomplete.
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.
You must submit supporting documentation to verify your eligibility to apply for this vacancy. For most applicants, an SF-50 will be required. However, if you are applying as a Veteran, individual with a qualifying disability, or a displaced employee, you will be required to provide other supporting documents as applicable. See the Required Documents section for more details.
Education
EDUCATION : THIS POSITION HAS A POSITIVE EDUCATION REQUIREMENT.
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 U.S. Department of Education website for Foreign Education Evaluation
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 in positions with the FDA, the agency 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 07/05/2024, 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.
Only the first 100 candidates who apply to this announcement will be considered for this position.
ADDITIONAL CONDITIONS OF EMPLOYMENT:

• Pre-employment physical required: NO
• Drug testing required: NO
• License required: NO
• Mobility agreement required: NO
• Immunization required: NO
• Bargaining Unit : YES, 3591
• Travel required: Yes, up to 25%
• Ethics Pre-Employment Clearance required: No
• Financial Disclosure Agreement: Yes
• Telework eligible: Yes, at the discretion of the supervisor.
• 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.
• If you are serving, or have served in the last 5 years (from 07/05/2024) 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

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.
All requirements must be met by the closing date of this announcement (07/05/2024); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process.

• Benefits
  A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
  Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.

How You Will Be Evaluated
You will be evaluated for this job based on how well you meet the qualifications above.
Additional selections may be made for similar positions across the Department of Health and Human Services (HHS) within the local commuting area(s) of the location identified in this announcement. By applying, you agree to have your application shared with interested selecting official(s) at HHS. Clearance of CTAP/ICTAP will be applied for similar positions across HHS.
Once the job opportunity announcement closes (at 11:59 pm Eastern Time on 07/05/2024), 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. Oral Communication
2. Technical Competence
3. Compliance Inspection

To preview the application questionnaire, click the link below.
https://apply.usastaffing.gov/ViewQuestionnaire/12444277

• Benefits
  A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
  Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
• Required Documents
  As a new or existing federal employee, you and your family may have access to a range of benefits. Your benefits depend on the type of position you have - whether you're a permanent, part-time, temporary or an intermittent employee. You may be eligible for the following benefits, however, check with your agency to make sure you're eligible under their policies.
  Resume: At a minimum, your resume should list the position title, employer name, start and end dates (including month and year), salary (or grade and step), hours worked per week, and a list of duties performed or accomplishments, for EACH position listed. A CV (curriculum vitae) may not contain enough information to meet these resume requirements.
  
  • Resume Writing Tutorial
  • Resume Writing FAQ
  Performance Appraisal: A performance appraisal must be provided if you wish to be considered as a:
  
  • Current/Former land management agency employee eligible under the Land Management Workforce Flexibility Act.
  • Family member formerly serving overseas eligible under Executive Order 12721.
  Current and Former Federal Employees: To properly verify eligibility and time-in-grade, you must submit the following:
  
  • Your most recent SF-50 (e.g., Promotion, Within Rate/Grade Increase (WRI/WGI), Appointment, Reassignment, Separation, etc.) showing you are/were in the competitive service and the highest grade or promotion potential held. SF-50 submitted cannot be an annual pay adjustment or award because they do not provide information needed to determine time-in-grade.
  • Your SF-50 must show the following information:
  1. Full position title
  2. Appointment type
  3. Pay Plan, Series, Grade & Step
  4. Tenure code
  5. Service Computation Date (SCD).
  I/CTAP: If you are a current/former Federal employee who is surplus or displaced, please submit supporting documentation (e.g., a Certification of Expected Separation, separation notice, RIF separation notice, notice of proposed removal, SF-50 for RIF separation, etc.) and your most recent performance appraisal. To be selected under I/CTAP, you must be found well-qualified for this position and have a current performance appraisal rating of at least "Fully Successful". See the How You Will Be Evaluated section for the agency's definition of well-qualified. Learn more on the USAJOBS Career Transition Assistance Site.
  Schedule A (individuals with disabilities ): Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities, may apply for appointment through the Schedule A hiring authority. Certified verification of a disability from a licensed medical professional; a licensed vocational rehabilitation specialist; or any Federal, state, or District of Columbia agency or U.S. territory that issues or provides disability benefits will be required.
  Military spouses eligible for a noncompetitive appointment: Documentation verifying marriage (e.g., marriage certificate) and as applicable, copy of the service member's DD-214 or Statement of Service; copy of the service member's VA disability letter; statement certifying you are the un-remarried widow or widower of the service member; and documentation of the service member's death while on active duty (e.g., DD-1300).
  Special appointing authority for veterans and Veterans' Preference. Veterans must submit a DD-214 (Certificate of Release or Discharge) that has the dates of service and discharge status and VA disability letter (if applicable) as proof of eligibility under a special appointing authority for veterans (e.g., VEOA, etc.) and proof for veterans' preference.
  
  • Active Duty Members: To claim status under the VOW (Veterans Opportunity to Work) to Hire Heroes Act of 2011, submit written documentation from the armed forces that certifies the service member is expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the certification is submitted with your application package.
  • Parents of Deceased or Disabled Veterans: To claim preference, you must submit a copy of the deceased or disabled veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference. Please follow the instructions in the SF-15 on required documentation to be submitted.
  • Widow or Widower : To claim preference, you must submit a copy of the deceased or disabled veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference. Please follow the instructions in the SF-15 on required documentation to be submitted.
  • Spouse of a Living Veteran: To claim preference, you must submit a copy of the veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference, and Documentation of Veteran's Inability to Work Because of a Service-Connected Disability. Please follow the instructions in the SF-15 on required documentation to be submitted.
  If you are relying on your education to meet qualification requirements:
  Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from
  schools accredited by accrediting institutions recognized by the U.S. Department of Education.
  Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.
• How to Apply
  To apply for positions with the Food & Drug Administration, you must have a USAJOBS Login.GOV account, and be signed in to that account, before you click "Apply Online". See the USAJOBS Help Site article "How does the application process work?" for more on this process. Additionally, you must provide a resume and any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement, 07/05/2024 We recommend that you start the application process early enough that you can complete and submit your application before this deadline.
  Please note that you cannot submit documentation or make changes to your application after the close date.
  If you would like to learn how to use USAJOBS including: accessing and managing your account, adding saved documents, building a resume, or starting an application; we recommend you visit the USAJOBS How To site, and read up on any topic that you need help with. This site is located at: https://www.usajobs.gov/Help/how-to/. Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Help site at: https://www.usajobs.gov/Help/. FDA's Applicant Help Desk is not able to support USAJOBS-related issues.
  The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are not familiar with Application Manager or encounter any difficulty with the site, we recommend that you review the Applicant HELP Site at: https://help.usastaffing.gov/Apply/index.php?title=Applicant. This help site contains step-by-step instructions for completing the application process, submitting documentation, and completing questionnaires, and should be very helpful to you!
  You are encouraged to apply online. Applying online will allow you to review and track the status of your application. The FDA will provide reasonable accommodation to applicants with disabilities who are not able to apply online. If you need a reasonable accommodation for any part of the application process, please contact the Applicant Help Desk. Decisions on granting a reasonable accommodation will be made on a case-by-case basis.
  If after reviewing the USAJOBS and Application Manager help sites, you're not able to find the answer to your question or concern, or if you wish to request a reasonable accommodation, please contact the FDA Applicant Help Desk at 888-478-4340 , or e-mail QuickQuestions@fda.gov . The Applicant Help Desk is staffed between the hours of 7am and 6pm Eastern Time, Monday through Friday, except for government holidays. If you contact the Applicant Help Desk, please provide the following Vacancy Identification Number (VIN) 12444277 so that we may assist you faster.
  Agency contact information
  FDA Applicant Help Desk
  Phone
  866-807-3742
  Email
  eric@fda.hhs.gov
  Address
  FDA Center for Biologics Evaluation and Research
  10903 New Hampshire Ave
  Silver Spring, MD 20993
  US
  Next steps
  HHS has a critical preparedness and response mission: HHS protects the American people from health threats, researches emerging diseases, and mobilizes public health programs with domestic and international partners. In support of this mission, HHS offers its employees the opportunity to volunteer to become Federal Civilian Detailees and contribute their unique skills through voluntary temporary assignments to humanitarian emergencies or Departmental priorities countering new and emerging health, safety, and security threats.
  Once your application is submitted you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We strive to make selections within 45 days of the closing date of this announcement.
  You will receive application status updates by email and on USAJOBS as the process unfolds.
  How to check your application status via USAJOBS and understand what each status means.
  How does the Hiring Process Work?
  Additional selections may be made for similar positions across the Department of Health and Human Services (HHS) within the local commuting area(s) of the location identified in this announcement. By applying, you agree to have your application shared with interested selecting official(s) at HHS. Clearance of CTAP/ICTAP will be applied for similar positions across HHS.
  Federal agencies may request information regarding the vaccination status of selected applicants for the purposes of implementing other workplace safety protocols, such as protocols related to masking, physical distancing, testing, travel, and quarantine.
• Fair and Transparent
  The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
  
  • Criminal history inquiries
  • Equal Employment Opportunity (EEO) Policy
  • Financial suitability
  • New employee probationary period
  • Privacy Act
  • Reasonable accommodation policy
  • Selective Service
  • Signature and false statements
  • Social security number request

Required Documents
Resume: At a minimum, your resume should list the position title, employer name, start and end dates (including month and year), salary (or grade and step), hours worked per week, and a list of duties performed or accomplishments, for EACH position listed. A CV (curriculum vitae) may not contain enough information to meet these resume requirements.

• Resume Writing Tutorial
• Resume Writing FAQ

Performance Appraisal: A performance appraisal must be provided if you wish to be considered as a:

• Current/Former land management agency employee eligible under the Land Management Workforce Flexibility Act.
• Family member formerly serving overseas eligible under Executive Order 12721.

Current and Former Federal Employees: To properly verify eligibility and time-in-grade, you must submit the following:

• Your most recent SF-50 (e.g., Promotion, Within Rate/Grade Increase (WRI/WGI), Appointment, Reassignment, Separation, etc.) showing you are/were in the competitive service and the highest grade or promotion potential held. SF-50 submitted cannot be an annual pay adjustment or award because they do not provide information needed to determine time-in-grade.
• Your SF-50 must show the following information:

1. Full position title
2. Appointment type
3. Pay Plan, Series, Grade & Step
4. Tenure code
5. Service Computation Date (SCD).

I/CTAP: If you are a current/former Federal employee who is surplus or displaced, please submit supporting documentation (e.g., a Certification of Expected Separation, separation notice, RIF separation notice, notice of proposed removal, SF-50 for RIF separation, etc.) and your most recent performance appraisal. To be selected under I/CTAP, you must be found well-qualified for this position and have a current performance appraisal rating of at least "Fully Successful". See the How You Will Be Evaluated section for the agency's definition of well-qualified. Learn more on the USAJOBS Career Transition Assistance Site.
Schedule A (individuals with disabilities ): Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities, may apply for appointment through the Schedule A hiring authority. Certified verification of a disability from a licensed medical professional; a licensed vocational rehabilitation specialist; or any Federal, state, or District of Columbia agency or U.S. territory that issues or provides disability benefits will be required.
Military spouses eligible for a noncompetitive appointment: Documentation verifying marriage (e.g., marriage certificate) and as applicable, copy of the service member's DD-214 or Statement of Service; copy of the service member's VA disability letter; statement certifying you are the un-remarried widow or widower of the service member; and documentation of the service member's death while on active duty (e.g., DD-1300).
Special appointing authority for veterans and Veterans' Preference. Veterans must submit a DD-214 (Certificate of Release or Discharge) that has the dates of service and discharge status and VA disability letter (if applicable) as proof of eligibility under a special appointing authority for veterans (e.g., VEOA, etc.) and proof for veterans' preference.

• Active Duty Members: To claim status under the VOW (Veterans Opportunity to Work) to Hire Heroes Act of 2011, submit written documentation from the armed forces that certifies the service member is expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the certification is submitted with your application package.
• Parents of Deceased or Disabled Veterans: To claim preference, you must submit a copy of the deceased or disabled veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference. Please follow the instructions in the SF-15 on required documentation to be submitted.
• Widow or Widower : To claim preference, you must submit a copy of the deceased or disabled veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference. Please follow the instructions in the SF-15 on required documentation to be submitted.
• Spouse of a Living Veteran: To claim preference, you must submit a copy of the veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference, and Documentation of Veteran's Inability to Work Because of a Service-Connected Disability. Please follow the instructions in the SF-15 on required documentation to be submitted.

If you are relying on your education to meet qualification requirements:
Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from
schools accredited by accrediting institutions recognized by the U.S. Department of Education.
Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.
How to Apply
To apply for positions with the Food & Drug Administration, you must have a USAJOBS Login.GOV account, and be signed in to that account, before you click "Apply Online". See the USAJOBS Help Site article "How does the application process work?" for more on this process. Additionally, you must provide a resume and any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement, 07/05/2024 We recommend that you start the application process early enough that you can complete and submit your application before this deadline.
Please note that you cannot submit documentation or make changes to your application after the close date.
If you would like to learn how to use USAJOBS including: accessing and managing your account, adding saved documents, building a resume, or starting an application; we recommend you visit the USAJOBS How To site, and read up on any topic that you need help with. This site is located at: https://www.usajobs.gov/Help/how-to/. Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Help site at: https://www.usajobs.gov/Help/. FDA's Applicant Help Desk is not able to support USAJOBS-related issues.
The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are not familiar with Application Manager or encounter any difficulty with the site, we recommend that you review the Applicant HELP Site at: https://help.usastaffing.gov/Apply/index.php?title=Applicant. This help site contains step-by-step instructions for completing the application process, submitting documentation, and completing questionnaires, and should be very helpful to you!
You are encouraged to apply online. Applying online will allow you to review and track the status of your application. The FDA will provide reasonable accommodation to applicants with disabilities who are not able to apply online. If you need a reasonable accommodation for any part of the application process, please contact the Applicant Help Desk. Decisions on granting a reasonable accommodation will be made on a case-by-case basis.
If after reviewing the USAJOBS and Application Manager help sites, you're not able to find the answer to your question or concern, or if you wish to request a reasonable accommodation, please contact the FDA Applicant Help Desk at 888-478-4340 , or e-mail QuickQuestions@fda.gov . The Applicant Help Desk is staffed between the hours of 7am and 6pm Eastern Time, Monday through Friday, except for government holidays. If you contact the Applicant Help Desk, please provide the following Vacancy Identification Number (VIN) 12444277 so that we may assist you faster.
Agency contact information
FDA Applicant Help Desk
Phone
866-807-3742
Email
eric@fda.hhs.gov
Address
FDA Center for Biologics Evaluation and Research
10903 New Hampshire Ave
Silver Spring, MD 20993
US
Next steps
HHS has a critical preparedness and response mission: HHS protects the American people from health threats, researches emerging diseases, and mobilizes public health programs with domestic and international partners. In support of this mission, HHS offers its employees the opportunity to volunteer to become Federal Civilian Detailees and contribute their unique skills through voluntary temporary assignments to humanitarian emergencies or Departmental priorities countering new and emerging health, safety, and security threats.
Once your application is submitted you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We strive to make selections within 45 days of the closing date of this announcement.
You will receive application status updates by email and on USAJOBS as the process unfolds.
How to check your application status via USAJOBS and understand what each status means.
How does the Hiring Process Work?
Additional selections may be made for similar positions across the Department of Health and Human Services (HHS) within the local commuting area(s) of the location identified in this announcement. By applying, you agree to have your application shared with interested selecting official(s) at HHS. Clearance of CTAP/ICTAP will be applied for similar positions across HHS.
Federal agencies may request information regarding the vaccination status of selected applicants for the purposes of implementing other workplace safety protocols, such as protocols related to masking, physical distancing, testing, travel, and quarantine.
Fair & Transparent
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.

• Criminal history inquiries
• Equal Employment Opportunity (EEO) Policy
• Financial suitability
• New employee probationary period
• Privacy Act
• Reasonable accommodation policy
• Selective Service
• Signature and false statements
• Social security number request