This Position Is No Longer Available
  1. Overview
  2. Duties
  3. Qualifications & Evaluations
  4. Benefits & Other Info
  5. How to Apply

Job Title:INTERDISCIPLINARY SCIENTIST (QUALITY ASSURANCE MANAGER), GS-13

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-ORA-MP-13-860275

This position is closed and no longer accepting online applications through USAJOBS.

The contents of the announcement can still be viewed.

SALARY RANGE:

$96,867.00 to $125,926.00 / Per Year

OPEN PERIOD:

Tuesday, March 26, 2013 to Thursday, April 25, 2013

SERIES & GRADE:

GS-0401/0403/1320-13

POSITION INFORMATION:

Full Time - Permanent

PROMOTION POTENTIAL:

13

DUTY LOCATIONS:

1 vacancy in the following location:
Alameda, CA United StatesView Map

WHO MAY APPLY:

AGENCY EMPLOYEES: FDA ORA PACIFIC REGION

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 is an interdisciplinary scientist position and may be filled in one of the following disciplines: 

- Biologist, GS-0401
- Microbiologist, GS-0403
- Chemist, GS-1320

This position serves as the front line focal point to implement, develop and maintain ORA Quality Management Systems (OMS) in the laboratory.

WHO MAY APPLY:  This vacancy is open to current permanent (career/career-conditional appointments) employees of the Food and Drug Administration, Office of Regulatory Affairs, Pacific Region only. 

LOCATION:  This position is located in the Food and Drug Administration, Office of Regulatory Affairs, Pacific Region, San Francisco District Office, Alameda, CA.

TYPE OF POSITION:  This position is being filled on a full-time, permanent basis.

PROMOTION POTENTIAL:  GS-13 is the full performance level.  

Salary range listed includes locality pay.

KEY REQUIREMENTS

  • U.S. Citizenship is required.
  • All application materials must be received by the closing date.
  • Please carefully read and follow the HOW TO APPLY instructions.
  • Must meet time-in-grade requirement within 30 days of the closing date.
  • 25% travel may be required.

DUTIES:

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The incumbent will be responsible for the development and maintenance of a quality control/assurance program that assures quality work products and offers clear guidelines and quality standards.  Major duties include:

  • Plan, organize, and direct laboratory quality assurance programs, ensuring effectiveness and correction of all deficiencies found during audits
  • Review and evaluate the results of analyses conducted under these quality assurance programs
  • Evaluate quality assurance programs and results of quality assurance reviews
  • Based on reviews, develop innovative ways of conducting business, which may include authoritative recommendations (both within and outside the laboratory) on instrumentation and other technical modifications, reprogramming of resources, or changes to existing quality assurance programs
  • Write summaries and reports addressing such areas as problems and deficiencies, corrective actions taken, and recommendations for strengthening and improving programs
  • Manage and maintain appropriate audit schedules and tracking systems to ensure timely audits are performed


QUALIFICATIONS REQUIRED:

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In addition to meeting the educational requirements, candidates must possess one year of specialized experience at the next lower grade by the closing date of this vacancy announcement and meet the time-in-grade requirement:

GS-13: 52 weeks of specialized experience at least equivalent to the GS-12 level.

SPECIALIZED EXPERIENCE:  Experience directly related to the position to be filled which has equipped the candidate with the particular knowledge, skills, and abilities needed to successfully perform the duties of the position, and that is typically in or related to the position to be filled which includes planning, organizing, and directing laboratory quality assurance programs; reviewing and evaluating results of analysis conducted under the quality assurance programs and preparing summaries/reports addressing problems or deficiencies in order to improve the program.

TIME-IN-GRADE REQUIREMENT: (Must be met within 30 days of the closing date of this announcement)

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


Education Statement - Individual Occupation Requirement:
This position has an education requirement. You must submit a copy of your transcripts (or a 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.

If you have Federal status and have never been on an appointment in this occupational series, you must submit your transcripts as indicated above. If you have Federal status and are currently or were previously on an appointment in this 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.

To qualify, applicants must have successfully completed one of the following:

FOR BIOLOGIST, GS-0401

A.  4 Year Degree: Biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position OR

B.  Combination of education and experience--Courses equivalent to a major, as shown in A above, plus appropriate experience or additional education.

FOR MICROBIOLOGIST, GS-0403

A.  4 Year Degree: 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 OR

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.

FOR CHEMIST, GS-1320

A.  4 Year Degree: 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 OR

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.

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 may be paid: Yes 

5.  Bargaining Unit Position: No 

6.  Drug Screening Required: No 

7.  Recruitment Bonus may be authorized: No 

8.  Supervisory position: No

9.  Time-in-grade (TIG) must be met within 30 days of the closing date of the announcement.

10.    Certain positions within the FDA are subject to strict restrictions on financial holdings (FDA regulated financial holdings).   To determine whether this position is affected, applicants are advised to seek additional information during the interview process from the Ethics and Integrity Staff, Office of Management Programs, Office of Management at (301)827-5511 prior to accepting such a position.

 

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): 

  1. Knowledge of the legislation, laws, precedents, and regulations which govern the activities of a scientific laboratory quality assurance program.
  2. Ability to interpret analytical data and organize scientific information related to the Quality System.
  3. Ability to communicate orally and in writing.  


BENEFITS:

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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:

If you are a veteran with preference eligibility and you are claiming 5-points veterans' preference, you must submit a copy of your DD-214 or other proof of eligibility.  If you are claiming 10-point veterans' preference, you must also submit an SF-15, "Application for 10-Point Veterans' Preference" plus the proof required by that form.  For more information on veterans’ preference see http://www.usajobs.gov/Veterans.

 

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

 

Interagency Career Transition Assistance Program (ICTAP):  For information on how to apply as an ICTAP eligible see http://opm.gov/rif/employee_guides/career_transition.asp#ictap.  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:

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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 860275.  Fax your documents to 1-478-757-3144.


If you cannot apply online:

  1. Click the following link to view and print the assessment questionnaire View Occupational Questionnaire, and
  2. Print this 1203FX form to provide your response to the assessment questionnaire http://www.opm.gov/forms/pdf_fill/OPM1203fx.pdf and
  3. 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 Customer HelpDesk at (888) 478-4340; TTY/TDD: (800) 877-8339; 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:

1.   Your Résumé

2.   A complete Assessment Questionnaire

3.   Other supporting documents:

  • College Transcripts (if the position has a positive education requirement)
  • PHS Commissioned Corps Officer must submit a copy of latest personnel order
  • SF-50 (including the highest grade held)

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 SF50 or SF52 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. 

Note:  You may submit an unofficial transcript or a list of college courses completed indicating course titles, credit hours, and grades received.  An official transcript from an accredited educational institution is required if you are selected for the position.  

 

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 Thursday, April 25, 2013.

AGENCY CONTACT INFO:

FDA Helpdesk
Phone: (888)478-4340
Fax: (478)757-3144
Email: QUICKQUESTIONS@PSC.GOV
Agency Information:
HHS FDA Center
10903 New Hampshire Avenue
Silver Spring, MD
20993 Fax: (478)757-3144

WHAT TO EXPECT NEXT:

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).


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Job Announcement Number:

HHS-FDA-ORA-MP-13-860275

Control Number:

340131600