Job Description

Job Summary

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.

This Interdisciplinary Scientist position will be filled as one of the following disciplines: 0401 Biologist, 0403 Microbiologist, or 1320 Chemist.

 

This position is located in the Center for Drug Evaluation and Research (CDER), Office of Compliance (OC). As an Interdisciplinary Scientist, you will be responsible for the evaluation of Current Good Manufacturing Practices (CGMPs) and/or drug applications and supplements associated with the manufacturing of human drug products.

This Job Opportunities Announcement will be open continuous for 90 days. The first cut-off date for applications received for consideration and/or referred to the hiring agency will be June 30, 2013. Subsequent referrals will be issued every 30 days until the announcement closes.

 

This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-CDER-MP-13-881057 under Merit Promotion procedures. Please review that announcement to see if you are eligible for consideration under Merit Promotion procedures. NOTE: Applicants must apply separately for each announcement in order to be considered.

This job opportunity announcement may be used to fill additional vacancies.

Duties

  • Performs administrative and scientific regulatory review for Current Good Manufacturing Practices (CGMP) of products and facilities and/or with drug applications, supplements, and amendments.
  • Provides advice and guidance within assigned product area to manufacturers, consumers, investigators, other reviewers, and agency committees on CGMPs on process validation, environmental issues and/or facility design.
  • Evaluates facility design, operation, manufacturing and testing procedures to ensure compliance with CGMP regulations and policies. 
  • Meets with representatives of the regulated drug industry about potential product and establishment issues

    or scientific/regulatory issues involving drug products.

Additional Information

What To Expect Next

You will be notified of your status when the list of candidates has been referred to the hiring manager for employment consideration.  


BENEFITS

The Federal government offers a comprehensive benefits package.  Explore the major benefits offered to most Federal employees at http://www.opm.gov/retire/retire_jobseekers.asp.


Other Information

Veterans' Preference: If you are a veteran claiming 5-point veterans' preference, you must submit a copy of your DD-214 (Member Copy 4) or an official statement (including Character of Service) from your command if currently on active duty. If you are claiming 10-point veterans' preference, in addition to the DD-214, you must also submit a Standard Form 15 (Application for 10-Point Veteran Preference) and the required supporting documents listed on that form.  For more information on veterans' preference see www.fedshirevets.gov. 

 

Career Transition Program:  This program applies to Federal workers whose positions have been deemed 'surplus' or no longer needed, or an employee has been involuntarily separated from a Federal service position within the competitive service.  To receive selection priority for this position, you must be rated 'well-qualified.  Well-qualified means eligible applicants whose knowledge, skills, and abilities clearly exceed the minimum qualification requirements of the position.

For information on how to apply and what documents to submit as a CTAP/ICTAP eligible, go to: http://www.opm.gov/rif/employee_guides/career_transition.asp

Selective Service:  The Defense Authorization Act of 1986 requires that all male applicants born after 12/31/59 who are required to register under the Military Selective Service Act, be registered or they are not eligible for appointment to this position.  For further information concerning Selective Service requirements, please visit http://www.sss.gov/.

How to Apply

To apply for this position, you must complete the occupational questionnaire and submit the documentation specified in the Required Documents section below.

The complete application package must be submitted by 11:59 PM (EST) on Friday, August 30, 2013 to receive consideration.

* To begin, click Apply Online to create a USAJOBS account or log in to your existing account. Follow the prompts to select your USAJOBS resume and/or other supporting documents and complete the occupational questionnaire.

* Click the Submit My Answers button to submit your application package.

* 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 and click 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.

 

To return to an incomplete application, log into your USAJOBS account @ https://my.usajobs.gov/Account/Login  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.

 

To complete a hard copy assessment questionnaire and submit it via fax: Do not complete the steps below if you have already applied online to the questionnaire for this position.

1) Print the instructions and questionnaire by clicking View Occupational Questionnaire.

2) Print the 1203FX form to record your responses to the questionnaire.

3) Fax the completed 1203FX (all 6 pages but do not include a Cover Page for this document) to: 

1-478-757-3144

 

How You Will Be Evaluated

Once the job opportunity announcement closes, a review of your résumé and supporting documentation will be made and compared against your responses to the assessment questionnaire to determine if you are qualified for this job.

 

If, after reviewing your résumé and supporting documentation, a determination is made that you have inflated your responses when compared to your background information, 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.

 

Qualified candidates will be assigned to the following quality categories:

 

Best Qualified - Meets the minimum qualification requirements and excels in most requirements of the position.

 

Well Qualified - Meets the minimum qualification requirements and meets most requirements of the position.

 

Qualified - Meet the minimum qualification requirements, but does not possess the relevant competencies to a substantive degree. 

 

The category assignment is a measure of the degree in which your background matches the required competencies listed below for this position. 

 

  • Knowledge of drug manufacturing including biological, chemical or microbiological techniques.
  • Knowledge of Current Good Manufacturing Practices (CGMPs) regulations and related guidelines on drug manufacturing.
  • Communicate scientific and technical information orally.
  • Communicate scientific and technical information in writing.

 

Application of Veterans' Preference:  Under Category Rating procedures, veteran preference eligibles will receive selection consideration before non-preference eligibles within each quality category.

 

To preview the assessment questionnaire, click the following link:View Assessment Questions

Required Documents

  • Your Résumé - You are encouraged to use the USAJobs online resume builder to ensure that all required information is in your resume. If you use your own résumé, curriculum vitae, or any other written form you choose then you must describe your job-related qualifications that include beginning and ending dates for paid and non-paid work experience, hours worked per week, month and year of employment for each job title listed.
  • Responses to the Assessment Questionnaire
  • College Transcripts (that reflect the required degree or coursework for the occupation/series you are applying for)

 

Other Supporting Documents: (Only submit if applicable to you.)

 

  • Veterans' Preference documentation (i.e. SF-15, DD-214, Statement of Service, Service Connected Disability Letter, etc. ) 
  • CTAP/ICTAP documentation

 

If you are unable to upload supporting document(s) online, you can fax them by completing the following steps:

1. Print out a Fax Cover Page @ http://staffing.opm.gov/pdf/usascover.pdf and complete the required information. The Vacancy ID is 881071

2. Fax a Cover Page with each supporting document to 1-478-757-3144 by 11:59 PM (EST) on Friday, August 30, 2013to receive consideration. Keep a copy of your fax confirmation in the event verification is needed.

APPLICATION MATERIALS MUST BE RECEIVED BY MIDNIGHT (EASTERN TIME) ON THE CLOSING DATE OF THIS ANNOUNCEMENT

 

For Résumé and Application Tips visit: http://www.usajobs.gov/ResourceCenter/Index/Interactive/ResumeAndApplicationTips#icc