INTERDISCIPLINARY SCIENTIST (QUALITY ASSURANCE MANAGER), GS-13


Vacancy ID: 860275   Announcement Number: HHS-FDA-ORA-MP-13-860275   USAJOBS Control Number: 340131600

Social Security Number

Enter your Social Security Number in the space indicated. Your Social Security Number is requested under the authority of Executive Order 9397 to uniquely identify your records from those of other applicants who may have the same name.  As allowed by law or Presidential directive, your Social Security Number is used to seek information about you from employers, schools, banks and others who may know you. Providing your Social Security Number is voluntary, however we can not process your application without it.


Vacancy Identification Number

Enter 860275
1. Title of Job

INTERDISCIPLINARY SCIENTIST (QUALITY ASSURANCE MANAGER), GS-13
2. Biographic Data

3. E-Mail Address

4. Work Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

5. Employment Availability

Are you eligible for the Federal Employment Program for Persons with Disabilities? (For information on Schedule A appointments, see the OPM website.)


6. Citizenship

Are you a citizen of the United States?
7. Background Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

8. Other Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

9. Languages

If you are applying by the OPM Form 1203-FX, leave this section blank.

10. Lowest Grade

Enter the lowest grade level that you will accept for this position. The lowest grade for this position is 13.


13

11. Miscellaneous Information

12. Special Knowledge

If you are applying by the OPM Form 1203-FX, leave this section blank.

13. Test Location

If you are applying by the OPM Form 1203-FX, leave this section blank.

14. Veteran Preference Claim

15. Dates of Active Duty - Military Service

16. Availability Date

17. Service Computation Date

If you are applying by the OPM Form 1203-FX, leave this section blank.

18. Other Date Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

19. Job Preference

If you are applying by the OPM Form 1203-FX, leave this section blank.

20. Occupational Specialties

Choose 001 - Merit Promotion if you have not held a permanent position as Biologist at the highest grade level posted in this vacancy announcement.

Choose 002 - Reassignment/Non-Competitive Promotion if you, on a permanent basis, currently hold, or previously held, a position as Biologist at the GS-13 grade level or above, which has or had promotion potential to the GS-13 grade level or above in the Federal Service.

Choose 003 - Merit Promotion if you have not held a permanent position as Microbiologist at the highest grade level posted in this vacancy announcement.

Choose 004 - Reassignment/Non-Competitive Promotion if you, on a permanent basis, currently hold, or previously held, a position as Microbiologist at the GS-13 grade level or above, which has or had promotion potential to the GS-13grade level or above in the Federal Service.

Choose 005 - Merit Promotion if you have not held a permanent position as Chemist at the highest grade level posted in this vacancy announcement.

Choose 006 - Reassignment/Non-Competitive Promotion if you, on a permanent basis, currently hold, or previously held, a position as Chemist at the GS-13 grade level or above, which has or had promotion potential to the GS-13 grade level or above in the Federal Service.

 


001 COMPETITIVE PROMOTION - BIOLOGIST
002 REASSIGNMENT/NON-COMPETITIVE - BIOLOGIST
003 COMPETITIVE PROMOTION - MICROBIOLOGIST
004 REASSIGNMENT/NON-COMPETITIVE - MICROBIOLOGIST
005 COMPETITIVE PROMOTION - CHEMIST
006 REASSIGNMENT/NON-COMPETITIVE - CHEMIST

21. Geographic Availability

Select/enter at least one geographic location in which you are interested and will accept employment. The location code for this position is:


060010001 Alameda, CA

22. Transition Assistance Plan

23. Job Related Experience

24. Personal Background Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

25. Occupational/Assessment Questions:

1. From the descriptions below, select the one which best describes your education and/or experience and meets the basic qualification requirements for Biologist, GS-0401.

A. I have a degree in biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position.
B. I have a combination of education and experience -- Courses equivalent to a major, as shown in A above, plus appropriate experience or additional education.
C. I do not possess the education and/or experience described above.

2. From the descriptions below, select the one which best describes your education and/or experience and meets the basic qualification requirements for Microbiologist, GS-0403.

A. I have 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. I have a 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.

C. I do not possess the education and/or experience described above.

3. From the descriptions below, select the one which best describes your education and/or experience and meets the basic qualification requirements for Chemist, GS-1320.

A. I have 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. I have a 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.

C. I do not possess the experience and/or education described above.

4. From the descriptions below, select the one which best describes your experience and meets the Additional Qualification Requirements for Interdisciplinary Scientist, GS-13.

A. I have one year of specialized experience equivalent to the GS-12 grade level in the Federal service to include 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.

B. I do not possess the experience described above.

Your response will determine if you meet the time-in-grade requirements for this position. 

5. I have 52 weeks at the GS-12 grade level or above in the Federal Service within 30 days of the announcement closing date.

A. Yes
B. No

Your response to the statement below will determine if you meet the area of consideration.

6. I am a current employee with the Food and Drug Administration, Office of Regulatory Affairs, Pacific Region.

A. Yes
B. No

Your response to the statement below will determine if you are eligible for non-competitive referral.

7. Please select the appropriate response from the list below.

A. I am currently serving a permanent position at the GS-13 grade level or above in the Federal Service.
B. I have previously served in a permanent position at the GS-13 grade level or above in the Federal Service.
C. I do not meet the conditions described above.

For each task in the following group, choose the statement from the list below that best describes your experience and/or training. Darken the oval corresponding to that statement in Section 25 of the Qualifications and Availability Form C. Please select only one letter for each item.

A- I have not had education, training or experience in performing this task.
B- I have had education or training in performing the task, but have not yet performed it on the job.
C- I have performed this task on the job. My work on this task was monitored closely by a supervisor or senior employee to ensure compliance with proper procedures.
D- I have performed this task as a regular part of a job. I have performed it independently and normally without review by a supervisor or senior employee.
E- I am considered an expert in performing this task. I have supervised performance of this task or am normally the person who is consulted by other workers to assist them in doing this task because of my expertise.

8. Interpret and apply the Food, Drug and Cosmetics Act, related to industry practices, laws and regulations to ensure accuracy and completeness of objectives.

9. Monitor scientific work within a lab to see that priorities are met, what can be deferred, and what must be completed promptly.

10. Develop or modify existing guidelines and protocols for testing different FDA regulated products.

11. Ensure the Quality Management System is implemented when accomplishing assigned tasks.

12. Plan, organize and direct laboratory quality assurance programs ensuring effectiveness and correction of all deficiencies found.

13. Provide advice on tracking and trending Quality System activities as they relate to laboratory procedures.

14. Interpret quality management information system data.

15. Interpret and evaluate the results of analysis to determine the validity under the Quality Assurance Program.

16. Review and evaluate the results of analyses conducted under the Quality Management System.

17. Prepare scientific reports to support regulatory monitoring and enforcement actions.

18. Write summaries and reports addressing problems and deficiencies, corrective action taken and recommendations for strengthening and improving the programs in the laboratory.

19. Prepare written reports in support of the quality assurance program.

20. Provide status reports to management on work systems and status of correction action taken.