Quality Assurance Specialist, GS-1910-12/13


Vacancy ID: 779722   Announcement Number: HHS-FDA-CDER-DE-13-779722   USAJOBS Control Number: 330341800

Occupational/Assessment Questions:

1. Please select the letter below that best describe your experience that qualifies you for the Quality Assurance Specialist at the GS-12 level. Failure to select an answer will result in an ineligible rating.

A. I have one year of specialized experience, equivalent to the GS-11 in the Federal service that included: participating in the development of internal quality procedures and plans for scientific activities; conducting internal audits and management reviews of a regulatory program to ensure compliance with standards; and providing training to the internal staff on quality management system related matters.

B. I do not have the qualifications described above.

2. Please select the letter below that best describe your experience that qualifies you for the Quality Assurance Specialist at the GS-13 level. Failure to select an answer will result in an ineligible rating.

A. I have one year of specialized experience, equivalent to the GS-12 in the Federal service that included: developing internal quality procedures and plans for scientific activities; conducting internal audits and management reviews of a regulatory program to ensure compliance with standards and to recommend innovative solutions to deficiencies; and provides expert technical advice and guidance to management and other technical specialists on critical Quality Assurance issues.

B. I do not have the qualifications 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.

3. Participate in working groups to implement a quality management system for a program.

4. Establish and maintain an employee training database.

5. Participate in the writing, reviewing, and finalizing of an internal quality procedure process for a compliance program.

6. Track the development of internal quality procedures.

7. Interact with other cross-organizational programs to collect employee training needs.

8. Communicate with IT personnel on learning portal matters.

9. Participate in process improvement teams and root cause analysis teams.

10. Participate in the development of plans and programs for achieving and maintaining quality work products and services.

11. Coordinate internal or external career development trainings related to new and emerging technologies in drug applications.

12. Work with an educational committee to organize technical training needs for new employees.

13. Ensure training records for an organization are current.

14. Utilize quality management standards to evaluate the needs and areas of improvements regarding employee training programs.

15. Prepare high quality audit reports according to established audit procedures.

16. Utilize Microsoft Office Suite to produce and assist others in spreadsheet and correspondence creation.

17. Assist others in resolving Microsoft Access database issues.

18. Utilize Microsoft PowerPoint to develop highly technical presentations.