$84,035.00 to $109,245.00
Open & closing dates
$84,035 to $109,245 per year
Salary includes locality pay
Pay scale & grade
1 vacancy in the following location:
Relocation expenses reimbursed
This job is open to
U.S. citizens, nationals or those who owe allegiance to the U.S., and excepted service employees.
Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.
The FDA's Office of Regulatory Affairs (ORA) is the lead office for all FDA Field activities as well as providing FDA leadership on imports, inspections and enforcement policy. ORA supports FDA Product Centers by inspecting regulated products and manufacturers, conducting sample analysis on regulated products, and reviewing imported products offered for entry into the United States. ORA also develops FDA-wide policy on compliance and enforcement.
This position is located in the Office of Regulatory Affairs (ORA), Office of Regulatory Science (ORS) laboratory. One position to be filled in the following location:
Jamaica (Queens) , NY - $84,035 - $109,245
Additional selections may be made.
Learn more about this agency
As a Interdisciplinary Scientist (Quality Systems Specialist), you will have the following responsibilities:
The incumbent will serve as a Quality System Specialist for a Laboratory Branch performing regulatory sample analysis on FDA regulated products. Incumbent works in conjunction with other Quality System Specialists and the Quality System Manager.
Work closely with Laboratory Management and the Quality Systems Manager (QSM) in guiding, coordinating, and monitoring the overall quality of work products and management systems.
Develops and maintains segments of a quality control/assurance program that assures quality work products and offers clear guidelines and quality standards.
Participates in facilitating internal and external audits.
Provides advisory, liaison and consultative services for quality assurance programs related to one or more scientific disciplines.
Identifies training needs from quality system results and develops training plans to satisfy those needs.
Makes recommendations on analytical instrumentation and other technical modifications as well as changes to existing programs.
Occasional travel - Up to 10% travel may be required.
Who May Apply
This job is open to…
United States Citizens
Questions? This job is open to 1 group.
Job family (Series)
0401 General Natural Resources Management And Biological Sciences
Conditions of Employment
U.S. Citizenship is required for federal employment.
Only experience gained by the announcement closing date will be considered.
Selective Service registration is required for males born after 12/31/1959.
A security investigation and/or 1-year probationary period may be required.
Additional Conditions of Employment: Security and Background Requirements: Appointment will be subject to the applicant's successful completion of a background security investigation. Failure to successfully meet these requirements may be grounds for appropriate personnel action. If hired, a background security reinvestigation or supplemental investigation may be required at a later time. Applicants are also advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-consideration, non-selection or appropriate disciplinary action.
E-Verify: If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS E-Verify System. Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system. The U.S. Department of Health and Human Services is an E-Verify Participant.
Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.
Pre-employment physical required: No
Drug testing required: No
License required: No
Mobility agreement required: No
Immunization required: No
Bargaining Unit Position: No
All qualification requirements must be met by 11:59 pm (Eastern Time) on 02/22/2018.
In order to qualify for Interdisciplinary Scientist (Quality Systems Specialist), 0401/0403/1320, at GS - 12, you must meet the following:
Basic Education requirement:
This position has a basic education requirement. The basic qualification requirements for each of these series are provided below:
Biologist - GS-401:
A. Degree in biological sciences, agriculture, natural resource management,chemistry, or related disciplines appropriate to the position;
B. Combination of education and experience - courses equivalent to a major, as shown in A above, plus appropriate experience or additional education.
A. Bachelor's degree or higher from an accredited college or university in microbiology; or biology, chemistry, or basic medical science that included at least 20 semester hours in microbiology and 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.
B. Combination of education and experience - courses equivalent to a major in microbiology, biology, chemistry, or basic medical science that included courses as shown in A above, plus appropriate experience or additional education.
A. Bachelor's degree or higher from an accredited college or university 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.
B. 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: Applicants must have one year of specialized experience equivalent to the GS-11 grade level in the Federal service. Specialized experience is experience that has equipped the applicant with the necessary knowledge, skills and abilities to perform the duties of the position. Examples of specialized experience includes assisting in the planning, developing and maintaining laboratory quality assurance programs; reviewing and evaluating results of scientific analysis conducted under the quality assurance programs; and preparing summaries/reports addressing problems or deficiencies in order to improve the program.
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 claiming education as any part of your qualifications for this position, 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 to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program. For further information, click on foreign education ****Additional information
If you are serving, or have served in the last 5 years (from 02/22/2018) 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 Appointee FAQ - OPM
Veteran's Preference: If you plan to apply for any time of Veterans Preference, please pay careful attention to the Required Documents section for more information about what to provide in your application. USAJOBS Veterans Site
Selective Service Registration: Males born after December 31, 1959 must be registered or exempt from Selective Service. You can learn more by visiting the Selective Service Registration
Schedule A: If you plan to apply under Schedule A based on a disability, please pay careful attention to the Required Documents section for more information about what to provide in your application. Disability Employment
Inter-agency and Career Transition Assistance Programs: If you are a displaced Federal employee and plan to apply under CTAP or ICTAP, please pay careful attention to the Required Documents section for more information about what to provide in your application. Workforce Restructuring
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 ET on 02/22/2018), 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 Federal employment, and then whether or not you are qualified for this particular position.
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.
Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Basis of Rating: Category rating procedures will be used to rate and rank candidates. The category assignment is a measure of the degree in which your background matches the competencies required for this position. Qualified candidates will be assigned to one of the following quality categories: Best Qualified, Well Qualified, or Qualified.
The Category Rating Process does not add veteran's preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 10 percent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher).
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. To preview the application assessment questions, use the link below: Information Management
****Background checks and security clearance
Q - Sensitive
The following documents are ACCEPTED for this vacancy:
PHS Orders, Other
Accepted means that you will have the opportunity to submit these documents, if they are applicable to you. Such documents include Veteran Preference or other special eligibility documentation, transcripts, or other optional documentation that helps us determine your eligibility. The above list of documents may not apply to all applicants.
The following documents are REQUIRED for this vacancy:
Required indicates that the above documents are required to determine your qualification for this vacancy. These documents are collected from ALL applicants and failing to provide any of these documents may result in your application being deemed incomplete or not qualified. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application.
DOCUMENTATION REQUIREMENTS FOR APPLICANTS WHO QUALIFY FOR SPECIAL APPOINTING AUTHORITIES: Veterans: veteran eligibility documentation
(DD-214 Member #4 Copy, VA Letter, Standard Form (SF) 15 as applicable). Please note: If you are a veteran who has not yet been discharged, you may provide a statement of intent to discharge from your agency to receive Veterans Preference under the VOW (Veterans Opportunity to Work) to Hire Heroes Act of 2011.
Persons 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.
Displaced Federal employees who qualify for CTAP/ICTAP: If you are a former Federal employee who was displaced due to a Reduction-in-Force (RIF) or surplused by some other means, please submit a copy of the separation letter or RIF notice from your agency. To be selected under I/CTAP, you must still be found well-qualified for this position. Please see the OPM Guide to Career Transition
for more information.
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.
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. Learn more about federal benefits
Review our 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 to Apply
How to Apply
To apply for this position, you must complete the assessment questionnaire and submit all documentation specified in the Required Documents section. To receive consideration for this position, you must submit your complete application by 11:59 pm Eastern Time on the closing date of this announcement (02/22/2018)..
Instructions for applying to this job: You must be signed in to USAJOBS. If you do not have a USAJOBS account, you must first create one before you can apply
If you are signed in, you can tap/click Apply Online to begin the process.
USAJOBS will ask you to select a resume to submit. We recommend that you submit a USAJOBS Resume Builder formatted resume so that you know you're submitting all the information we will need. You may also submit a resume in the format of your choice. For tips on what to include in your resume, see the USAJOBS Resume Help
USAJOBS will then allow you to include documentation from your USAJOBS Saved Documents area. You may also attach additional supporting documents during this stage, or you may wait until you reach Application Manager.
You will then be required to respond to certify your application materials and you'll be given the chance to elect to provide demographic information (if you have completed this part of your USAJOBS profile).
Finally, you will be transferred to FDA's Application Manager (USA Staffing) system to complete the occupational questionnaire and finalize your application for submission. Follow the on-screen instructions provided and respond to ALL questions presented to you. You will be allowed to finalize and submit additional documents one last time. You will review your application and make final submission. You will then be returned back to USAJOBS.
Instructions for reviewing or editing your application: If you need to make a change to your application, or if you just want to know your application status, you will need to be logged in to your USAJOBS account. Tap/click on your name in the top-right corner, then select Applications.
You will see a list of the most recent applications you have submitted. Tap/click on the one you wish to review or edit. The item will expand and provide your current status, along with additional information about that application. If you wish to change something then tap/click the Update Application button.
You will be taken through the same steps you did when you initially applied. You can make changes to add or remove supporting documents before being transferred over to FDA's Application Manager system where you can continue making changes to your responses to the occupational questionnaire. Step through the process as you did the first time, taking care to make the changes you need, and submitting in the final step.
If you would like to preview the assessment questionnaire you may do so by clicking this link: ****You are encouraged to apply online. Applying online will allow you to review and track the status of your application. This agency provides reasonable accommodation to applicants with disabilities. If you need a reasonable accommodation for any part of the application and hiring process, please ****; TTY/****; or by email ****
. (If you request by e-mail, please replace the blank space in the body with the Vacancy Identification Number, VIN, which is:10129837.) Decisions on granting reasonable accommodation will be made on a case-by-case basis.
FDA Office of Regulatory Affairs
10903 New Hampshire Ave
Silver Spring, MD
Learn more about this agency
Once the online questionnaire is received 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 (02/22/2018).
You will receive application status updates via email and via USAJOBS as the process unfolds.
Fair & Transparent
Fair & Transparent
The Federal hiring process is setup to be fair and transparent. Please read the following guidance.
Equal Employment Opportunity Policy
The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.
Equal Employment Opportunity (EEO) for federal employees & job applicants
Reasonable Accommodation Policy
Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application and hiring process should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis.
A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits.
Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when: An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job.
An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace.
An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events.
You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis.
Learn more about disability employment and reasonable accommodations
or how to contact an agency.
Legal and regulatory guidance
Social security number request
Signature and false statements
New employee probationary period
Note: We cannot accept applications on behalf of Federal Agencies. Application instructions are listed within the Job Description.
U.S. Food and Drug Administration
Website : http://www.fda.gov/
FDA is an agency within the Department of Health and Human Services. The FDA's organization consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods, Global Regulatory Operations and Policy, and Operations. -