Interdisciplinary Scientist (Quality Assurance Manager) GS-0403/1320-13


Vacancy ID: 769540   Announcement Number: HHS-FDA-ORA-MP-13-769540   USAJOBS Control Number: 329197500

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 769540
1. Title of Job

Interdisciplinary Scientist (Quality Assurance Manager) GS-0403/1320-13
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 an ICTAP Eligible?

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.


Are you eligible for Indian preference as defined by the Department of the Interior (DOI) and as evidenced by appropriate Bureau of Indian Affairs (BIA) authorized certification?


Are you eligible for preference based on being a Public Law 94-437 Indian Health Service Scholarship recipient? For more information, please click here.    


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


Are you a PHS Commissioned Officer (This includes active duty officers, inactive reserve officers, and applicants who have been approved for commissioning in the USPHS Commissioned Corps)?


Are you eligible for noncompetitive appointment?
This includes applicants who are eligible for special or noncompetitive appointment authorities such as 30% or more compensable disabled veterans, persons with disabilities and PHS Commissioned Corps Officers.  This also includes applicants who meet the qualifications for this position and who have previously held, or currently hold, a Federal position at the grade of this position.


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

If you are a male at least 18 years of age, born after December 31, 1959, have you registered with the Selective Service System?


01 Yes
02 No
03 Not Applicable

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

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

15. Dates of Active Duty - Military Service

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

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

Select/enter at least one occupational specialty. The specialty code for this position is:


001 Interdisciplinary Scientist (Quality Assurance Manager)
002 Interdisciplinary Scientist (Quality Assurance Manager)

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:


203080091 Lenexa, KS

22. Transition Assistance Plan

23. Job Related Experience

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

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 an Interdisciplinary Scientist (Quality Assurance Manager) - 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.

2. From the descriptions below, select the one which best describes your education and/or experience and meets the Basic Qualification Requirements for Interdisciplinary Scientist (Quality Assurance Manager)-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.

3. From the descriptions below, select the one which best describes your experience and meets the Additional Qualification Requirements for Interdisciplinary Scientist (Quality Assurance Manager)-Microbiologist, GS-0403-13/Chemist, GS-1320-13.

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.

Knowledge of the legislation, laws, precedents, and regulations which govern the activities of a scientific laboratory quality assurance program.
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.

4. Responsible for the interpretation and application of the Food, Drug and Cosmetics Act, related to industry practices, laws and regulations to ensure accuracy and completeness of objectives.

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

6. Develop or modify existing guidelines and protocols for testing specific types of devices.

7. Ensure applicable laws, guidance and policies are implemented in accomplishing assigned tasks.

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

9. Work closely with laboratory management guiding, coordinating and monitoring the overall quality of work products and laboratory management systems.

10. Based on quality assurance reviews, develops innovative ways of conducting business which may include authoritative recommendations on instrumentation, technical modifications, reprogramming of resources or changes to existing quality assurance programs.

11. Provide advice concerning methodology problems to scientists and laboratory management.

12. Confirm results and findings of other scientist's analyses ensuring accuracy and consistency of content.

13. Interpret chemical analytical results/calculations independently.

14. Review background material such as collection reports, labeling, establishment inspection reports, pertinent Agency regulations, Federal law and other relevant material.

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 assurance programs.

17. Analyze difficult, novel and complex samples.

18. Modify or develop methods to satisfy special requirements under the Quality Assurance Program.

19. Conduct as warranted method development or modification of existing or modification to analyze and provide appropriate validation.

20. Determine the approach, methods, and procedures to use in order to obtain the information requested.

21. Perform independent scientific official methods and procedures and then carry out analyses to make determination for regulatory monitoring and enforcement.

22. Monitor the quality system documents issued to ensure accuracy and consistency of content.

23. Manage a document control system to ensure most current authorized documents are in use ensuring documents are available to all laboratory personnel.

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

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

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

27. Serve as a laboratory contact facilitating internal and external quality assurance audits ensuring corrective action is taken.

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

29. Identify training needs for quality assurance results and develops training plans to satisfy those needs.

30. Testify in court concerning the science produced.