Department:Department Of Health And Human Services
Agency:Food and Drug Administration
Job Announcement Number:HHS-FDA-MP-12-611055Agency:Food and Drug Administration
| SALARY RANGE: | $88,940.00 to $115,621.00 / Per Year |
| OPEN PERIOD: | Friday, April 13, 2012 to Sunday, May 13, 2012 |
| SERIES & GRADE: | GS-0696-13 |
| POSITION INFORMATION: | Full Time - Permanent |
| PROMOTION POTENTIAL:13 | |
| DUTY LOCATIONS: | 1 vacancy(s) - Grand Rapids, MI United States 1 vacancy(s) - Indianapolis, IN United States 1 vacancy(s) - Detroit Metro Area, MI United States |
| WHO MAY BE CONSIDERED: | Detroit District Office and Resident Post employees only |
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.
Who May Apply: This vacancy is open to current Food and Drug Administration (FDA) employees, Office of Regulatory Affairs (ORA), Detroit District employees with competitive status only. Competitive status refers to employees who are serving on a career or career conditional appointment.
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.
Applicants outside of the area of consideration will not be considered.
YOU MUST SUBMIT YOUR SF-50 (AND DD-214 IF APPLICABLE).
Your resume
A complete Assessment Questionnaire
Other supporting documents:
Veterans Preference Documentation, if applicable
College transcript(s), if qualifying based on education
This position is with the Department of Health and Human Services, Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Detroit District Office, Central Region. This position may be filled in one of the following locations: (Applicants must identify their location(s) of interest.) One or more positions may be filled from this vacancy announcement.
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.
Who May Apply: This vacancy is open to current Food and Drug Administration (FDA) employees, Office of Regulatory Affairs (ORA), Detroit District employees with competitive status only. Competitive status refers to employees who are serving on a career or career conditional appointment.
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.
Applicants outside of the area of consideration will not be considered.
YOU MUST SUBMIT YOUR SF-50 (AND DD-214 IF APPLICABLE).
Your resume
A complete Assessment Questionnaire
Other supporting documents:
Veterans Preference Documentation, if applicable
College transcript(s), if qualifying based on education
This position is with the Department of Health and Human Services, Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Detroit District Office, Central Region. This position may be filled in one of the following locations: (Applicants must identify their location(s) of interest.) One or more positions may be filled from this vacancy announcement.
- Detroit District Office
- Indianapolis Resident Post
- Grand Rapids Resident Post
- KEY REQUIREMENTS
- U.S. Citizenship is required.
- Travel required: 25%
- Financial disclosure required: Yes
- Driver's License required
DUTIES:
Major Duties:
1. Program Manager
Plans, conducts and directs highly technical, complex and multifaceted inspections and in-depth investigations related to production, control and testing of food products, is highly skilled in interview techniques as well as criminal investigation techniques and routinely make recommendation to regional and district management officials as to whether or not a firm/individual involved in food products is in compliance regarding Current Good Manufacturing Practices (CGMP) issues.
As a principal source of expertise within a geographical area provides extensive advisory, liaison and consultative services for food programs to regulated industries, State agencies, other Federal agencies and Agency management. Advises on new advances in technology related to food products, new programs, laws and regulations, significant court decisions, and any new trends or scientific finding involving food products.
Manages the review of previously approved products to determine whether they should continue to be permitted in light of current scientific safety criteria. Coordinates the collection of data, manages the scientific review and recommends a course of action.
Researches and prepares final background and decision papers for the signature of the Director.
Serves on task forces and study groups charged with considering problems of directors in the area of food programs. Consults with staff members at all levels of the organization to achieve consensus on issues and resolve any disagreements on standards.
Serves as an expert witness in area of expertise in court cases dealing with regulated products, is a member of the international inspection cadre and conducts inspections of both domestic and international food establishments.
2. Inspections and Investigations
Assignments cover the largest manufacturers in the District and some small firms where new or unusual features are present. Inspections cover all the types of products and problems with the area of assigned responsibility.
The investigator conducts the more complex, technical investigations and inspections of establishments in the are of assigned responsibility and prepares proposed or final EIR endorsements.
Independently performs investigations involving complaints of injury or death attributable to products regulated by the FDA. Investigations of injuries require special coordination and a high degree of insight and knowledge.
3. Instructor and Team Leader
Develops and implements formal training programs for Agency personnel, industry, and state/local officials, and provides technical expertise to industry representatives. Conducts on-the-job training for Consumer Safety Officers and others GS-12 and below and other training for investigators, supervisory, compliance officer, district or regional personnel, and industry regarding technical and scientific matters, inspectional/investigational issues, policies, and laws affecting the food program area.
Serves as a principal advisor or team in a field of regulatory and compliance expertise. The incumbent is responsible for planning, coordinating and evaluating the programs and activities for a professional regulatory field.
Major Duties:
1. Program Manager
Plans, conducts and directs highly technical, complex and multifaceted inspections and in-depth investigations related to production, control and testing of food products, is highly skilled in interview techniques as well as criminal investigation techniques and routinely make recommendation to regional and district management officials as to whether or not a firm/individual involved in food products is in compliance regarding Current Good Manufacturing Practices (CGMP) issues.
As a principal source of expertise within a geographical area provides extensive advisory, liaison and consultative services for food programs to regulated industries, State agencies, other Federal agencies and Agency management. Advises on new advances in technology related to food products, new programs, laws and regulations, significant court decisions, and any new trends or scientific finding involving food products.
Manages the review of previously approved products to determine whether they should continue to be permitted in light of current scientific safety criteria. Coordinates the collection of data, manages the scientific review and recommends a course of action.
Researches and prepares final background and decision papers for the signature of the Director.
Serves on task forces and study groups charged with considering problems of directors in the area of food programs. Consults with staff members at all levels of the organization to achieve consensus on issues and resolve any disagreements on standards.
Serves as an expert witness in area of expertise in court cases dealing with regulated products, is a member of the international inspection cadre and conducts inspections of both domestic and international food establishments.
2. Inspections and Investigations
Assignments cover the largest manufacturers in the District and some small firms where new or unusual features are present. Inspections cover all the types of products and problems with the area of assigned responsibility.
The investigator conducts the more complex, technical investigations and inspections of establishments in the are of assigned responsibility and prepares proposed or final EIR endorsements.
Independently performs investigations involving complaints of injury or death attributable to products regulated by the FDA. Investigations of injuries require special coordination and a high degree of insight and knowledge.
3. Instructor and Team Leader
Develops and implements formal training programs for Agency personnel, industry, and state/local officials, and provides technical expertise to industry representatives. Conducts on-the-job training for Consumer Safety Officers and others GS-12 and below and other training for investigators, supervisory, compliance officer, district or regional personnel, and industry regarding technical and scientific matters, inspectional/investigational issues, policies, and laws affecting the food program area.
Serves as a principal advisor or team in a field of regulatory and compliance expertise. The incumbent is responsible for planning, coordinating and evaluating the programs and activities for a professional regulatory field.
QUALIFICATIONS REQUIRED:
Qualifications:
Applicant must have successfully completed a four year course of study leading to a Bachelor's or higher degree that included at least 30 semester hours in one or a combination of the following: biological sciences, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, or related scientific fields that provided knowledge directly related to consumer safety officer work.
The 30 semester hours can 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
A combination of educations and experience - courses consisting of at least 30 semester hours in the fields of study described above, plus appropriate experience or additional educations.
This position has an education requirement. If you are currently or were previously on a permanent appointment in the occupational series, you do not need to submit transcripts at the time of application. Instead, you should submit an SF-50 showing that you were on an appointment in this occupational series. Otherwise, you must submit a copy of your transcripts (or list of your courses including titles, credit hours completed and grades) to document that you have met the education requirement. Unofficial transcripts will be accepted in the application package. Official transcripts will be required prior to beginning employment. Most colleges and universities offer unofficial transcripts online - please check your school website to obtain a copy quickly.
Applicants must possess at least one year of experience, equivalent to at least the GS-12 level in the Federal service planning and conducting technical, complex, and multi-faceted inspections and in-depth investigations, and recommending compliance of establishments engaged in the manufacture of pharmaceuticals (human or veterinary); expertise to industry representatives. Duties require skills in interview and criminal investigation techniques and in-depth knowledge of the Food, Drug and Cosmetic Act. For investigations and inspections, limited guidance documents were available and proposed to new regulations were used to evaluate the industry.
Documenting experience: 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.
Foreign Education: 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; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit: http://www.ed.gov.
Conditions of Employment:
1. Additional Security and Background Requirements: May be referred depending on the position being filled. If not previously completed, a background security investigation will be required for all appointees. Appointment will be subject to the applicant's successful completion of a background security investigation and favorable adjudication. Failure to successfully meet these requirements may be grounds for appropriate personnel action. In addition, 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 and/or appropriate disciplinary action.
2. All qualification requirements must be met by the closing date of the announcement.
3. Financial disclosure statement may be required.
4. Travel, transportation, and relocation expenses will be paid: No
5. Bargaining Unit Position:Yes
6. Drug Screening Required: No
7. Recruitment Bonus may be authorized: No
8. Research position: No
9. Supervisory position: No
10. Time in grade (TIG) must be met within 30 days of the closing date of the announcement.
HOW YOU WILL BE EVALUATED:
Once the application process is complete, a review of the resume 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 resume and/or supporting documentation, a determination is made that you have inflated your qualifications and/or experience, you may lose consideration for this position. Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Your qualifications will be evaluated and rated on the following competencies (knowledge, skills, abilities and other characteristics):
Ability to plan, organize, lead, and oversee major initiatives, progress, and programmatic results
Ability to apply laws, guidance, consultation and interpretation of policies
Skill in selecting, adapting and applying investigative methods and negotiating techniques
Ability to communicate orally
Skill in written communication
Qualifications:
Applicant must have successfully completed a four year course of study leading to a Bachelor's or higher degree that included at least 30 semester hours in one or a combination of the following: biological sciences, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, or related scientific fields that provided knowledge directly related to consumer safety officer work.
The 30 semester hours can 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
A combination of educations and experience - courses consisting of at least 30 semester hours in the fields of study described above, plus appropriate experience or additional educations.
This position has an education requirement. If you are currently or were previously on a permanent appointment in the occupational series, you do not need to submit transcripts at the time of application. Instead, you should submit an SF-50 showing that you were on an appointment in this occupational series. Otherwise, you must submit a copy of your transcripts (or list of your courses including titles, credit hours completed and grades) to document that you have met the education requirement. Unofficial transcripts will be accepted in the application package. Official transcripts will be required prior to beginning employment. Most colleges and universities offer unofficial transcripts online - please check your school website to obtain a copy quickly.
Applicants must possess at least one year of experience, equivalent to at least the GS-12 level in the Federal service planning and conducting technical, complex, and multi-faceted inspections and in-depth investigations, and recommending compliance of establishments engaged in the manufacture of pharmaceuticals (human or veterinary); expertise to industry representatives. Duties require skills in interview and criminal investigation techniques and in-depth knowledge of the Food, Drug and Cosmetic Act. For investigations and inspections, limited guidance documents were available and proposed to new regulations were used to evaluate the industry.
Documenting experience: 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.
Foreign Education: 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; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit: http://www.ed.gov.
Conditions of Employment:
1. Additional Security and Background Requirements: May be referred depending on the position being filled. If not previously completed, a background security investigation will be required for all appointees. Appointment will be subject to the applicant's successful completion of a background security investigation and favorable adjudication. Failure to successfully meet these requirements may be grounds for appropriate personnel action. In addition, 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 and/or appropriate disciplinary action.
2. All qualification requirements must be met by the closing date of the announcement.
3. Financial disclosure statement may be required.
4. Travel, transportation, and relocation expenses will be paid: No
5. Bargaining Unit Position:Yes
6. Drug Screening Required: No
7. Recruitment Bonus may be authorized: No
8. Research position: No
9. Supervisory position: No
10. Time in grade (TIG) must be met within 30 days of the closing date of the announcement.
HOW YOU WILL BE EVALUATED:
Once the application process is complete, a review of the resume 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 resume and/or supporting documentation, a determination is made that you have inflated your qualifications and/or experience, you may lose consideration for this position. Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Your qualifications will be evaluated and rated on the following competencies (knowledge, skills, abilities and other characteristics):
Ability to plan, organize, lead, and oversee major initiatives, progress, and programmatic results
Ability to apply laws, guidance, consultation and interpretation of policies
Skill in selecting, adapting and applying investigative methods and negotiating techniques
Ability to communicate orally
Skill in written communication
BENEFITS:
The Federal Government offers a comprehensive benefits package. Explore the major benefits offered to most Federal employees at http://www.usajobs.gov/ResourceCenter/Index/Interactive/Benefits#icc.
OTHER INFORMATION:
Males born after December 31, 1959 must be registered or exempt from Selective Service (see http://www.sss.gov).
For information on "People with Disabilities" please visit http://opm.gov/disability/PeopleWithDisabilities.asp.
Career Transition Assistance Program (CTAP): For information on how to apply as a CTAP eligible see http://opm.gov/rif/employee_guides/career_transition.asp#ctap. To be well-qualified and exercise selection priority for this vacancy, displaced Federal employees must be rated at 85.0 or above on the rating criteria for this position.
HOW TO APPLY: The Federal Government offers a comprehensive benefits package. Explore the major benefits offered to most Federal employees at http://www.usajobs.gov/ResourceCenter/Index/Interactive/Benefits#icc.
OTHER INFORMATION:
Males born after December 31, 1959 must be registered or exempt from Selective Service (see http://www.sss.gov).
For information on "People with Disabilities" please visit http://opm.gov/disability/PeopleWithDisabilities.asp.
Career Transition Assistance Program (CTAP): For information on how to apply as a CTAP eligible see http://opm.gov/rif/employee_guides/career_transition.asp#ctap. To be well-qualified and exercise selection priority for this vacancy, displaced Federal employees must be rated at 85.0 or above on the rating criteria for this position.
To begin the process, click the Apply Online button to create an account or log in to your existing USAJOBS account. Follow the prompts to complete the assessment questionnaire. Please ensure you click the Submit My Answers button at the end of the process.
Note: To return to a previously Saved or Incomplete application you may use the following link: https://applicationmanager.gov.
To fax supporting documents you are unable to upload, complete this cover page http://staffing.opm.gov/pdf/usascover.pdf using the following Vacancy ID 611055. Fax your documents to 1-478-757-3144.
If you cannot apply online:
- Click the following link to view and print the assessment questionnaire View Occupational Questionnaire, and
- Print this 1203FX form to provide your response to the assessment questionnaire http://www.opm.gov/forms/pdf_fill/OPM1203fx.pdf and
- Fax the completed 1203FX form along with any supporting documents to 1-478-757-3144. Your 1203FX will serve as a cover page for your fax transmission.
- 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 contact the Bethesda Center HelpDesk Telephone (888)-478-4340; TTY/TDD: (866)-539-4484; or by email quickquestions@psc.gov. The decision on granting reasonable accommodation will be made on a case-by-case basis.
REQUIRED DOCUMENTS:
To apply for this position, you must provide a complete Application Package which includes:
For Résumé and Application Tips visit: http://www.usajobs.gov/ResourceCenter/Index/Interactive/ResumeAndApplicationTips#icc.
The complete Application Package must be submitted by 11:59 PM (EST) on Sunday, May 13, 2012.
To apply for this position, you must provide a complete Application Package which includes:
- 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.
- A complete Assessment Questionnaire
- Other supporting documents:
- SF-50 (if you are a federal employee or have reinstatement rights as a federal employee)
- PHS Commissioned Corps Officer must submit a copy of latest personnel order
- College Transcripts (if the position has a positive education requirement)
For Résumé and Application Tips visit: http://www.usajobs.gov/ResourceCenter/Index/Interactive/ResumeAndApplicationTips#icc.
The complete Application Package must be submitted by 11:59 PM (EST) on Sunday, May 13, 2012.
AGENCY CONTACT INFO:
WHAT TO EXPECT NEXT: Bethesda Center Helpdesk
Phone: (888)478-4340 Fax: (478)757-3144 TDD: Email: QUICKQUESTIONS@PSC.GOV
Phone: (888)478-4340 Fax: (478)757-3144 TDD: Email: QUICKQUESTIONS@PSC.GOV
Agency Information:
OHR Bethesda Operations Center
7700 Wisconsin Ave
Bethesda, MD
20814 Fax: (478)757-3144
OHR Bethesda Operations Center
7700 Wisconsin Ave
Bethesda, MD
20814 Fax: (478)757-3144
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 expect to make a selection within 45 days of the closing date of this announcement.
You will receive notice via email or by mail, if no email address was provided by you during the application process, once this process is completed (generally 4-6 weeks).
