Quality Assurance Specialist-CC-DE


Vacancy ID: 863261   Announcement Number: NIH-CC-DE-13-863261   USAJOBS Control Number: 341483900

Occupational/Assessment Questions:

Thank you for your interest in the Quality Assurance Specialist, GS-1910-12 position at our agency. We will evaluate your resume and your responses to this Assessment Questionnaire to determine if you are among the best qualified for this position. Your responses are subject to verification. Please review your responses for accuracy before you submit this questionnaire.

1. Choose the one answer that best describes how you meet the basic qualification requirements for Quality Assurance Specialist, GS-1910-12 as described in the Qualifications Section of the Vacancy Announcement.

A. I qualify for this position at the GS-12 level because I have 1 year of specialized experience equivalent to at least the GS-11 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: planning and administering transfusion medicine quality assurance activities; implementing standard operating procedures related to transfusion medicine validation and inspection protocols; ensuring the proper execution of blood related operations in accordance with accrediting and regulatory agency requirements; administering consignee notification, product recall and market withdrawal systems; participating in the development of a transfusion medicine safety program; and preparing reports, documentation and presentations on quality assurance and improvement procedures.
B. My experience does not match the choice above.

The following section is used to determine your non-competitive eligibility or priority consideration. If you want non-competitive or priority consideration, you must submit the required documentation to verify your eligibility as indicated.

1. Schedule A (Individuals with Disabilities) - I am an individual who has a permanent, severe physical, psychiatric, or mental impairment that substantially limits one or more major life activities, and wish to be considered non-competitively.

 

NOTE: If you select "yes" in response to this question, you must submit Proof of Disability. If you are selected, you will be asked to provide a Certificate of Job Readiness. You can obtain this documentation from a licensed medical professional; licensed vocational rehabilitation specialist (State or private); or any Federal agency, State agency, agency of the District of Columbia, or a U.S. territory that issues or provides disability benefits.

 

For more information on this hiring flexibility, please visit the USAJobs Individuals with Disabilities Page

A. Yes
B. No

2. Commissioned Corps Member– I am currently an officer enlisted in the PHS Commissioned Corps. I am interested in staying in the Corps if selected. NOTE: If you select "yes" in response to this question, you will NOT be referred on the competitive Delegated Examining certificate of eligibles, as selection from that list would require you to resign or retire from the Corps. For more information on the Commissioned Corps, please visit the U.S. Public Health Service Commission Corps Website

 

 

 

A. Yes
B. No

3. Interagency Career Transition Assistance Plan (ICTAP)/Career Transition Assistance Plan (CTAP) -  I am a current or former federal employee displaced from a position in a federal agency (e.g., IRS, VA, Dept of Labor, etc.) in the same local commuting area of the vacancy. I have a current (or last) performance rating of record of at least fully successful or the equivalent. Applicants eligible under ICTAP/CTAP are provided priority selection for vacancies within the local commuting area for which they apply and are well qualified.

 

NOTE: If you select "yes" in response to this question, you must submit copies of the appropriate documentation, such as a reduction in force (RIF) separation notice, a SF-50 reflecting your RIF separation, or a notice of proposed removal for declining a directed reassignment or transfer of function to another commuting area. You must also submit documentation to reflect your current (or last) performance rating of record.

 

For more information on ICTAP/CTAP, please visit OPM’s The Employee's Guide to Career Transition Page.

A. Yes
B. No

For each task in the following group, choose the statement from the list below that best describes your experience and/or training.

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.

1. Implement departmental policies for equipment qualification and installation.

2. Implement departmental policies for computer system validation.

3. Administer a system for consignee notifications.

4. Administer a system for product recalls.

5. Administer a system for market withdrawals.

6. Implement an internal audit system to evaluate quality assurance and improvement process.

7. Develop and implement a safety program.

8. Establish quality assurance program goals for an organization or program.

For the following question, please indicate YES or NO to best describe your experience and/or training.

9. Have you implemented an internal audit system to evaluate multiple stages of the process (e.g., donor suitability, blood collection, component manufacturing, product labeling, etc.)?

A. Yes
B. No

For each task in the following group, choose the statement from the list below that best describes your experience and/or training.

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.

10. Maintain an index of standard operating procedures, master copies and archives of obsolete versions.

11. Validate and document modifications or changes to standard operating procedures.

12. Ensure that standard operating procedures comply with the Food and Drug Administration (FDA) regulations.

13. Ensure that standard operating procedures comply with the Standards of the American Association of Blood Banks (AABB) regulations.

14. Ensure adherence to organizational standard operating procedures prior to quality assurance program implementation.

15. Review and recommend improvements to standard operating procedures and instructions for quality assurance activities (e.g., quality assurance plan, systems monitoring, internal audit, etc.).

16. Review manufacturing records prior to the release of blood or tissue products for transfusion.

17. Establish and review employee job descriptions and management responsibilities for accuracy.

18. Monitor and evaluate proficiency testing programs.

19. Evaluate errors or accidents and determine if they are reportable to the Food and Drug Administration (FDA).

20. Ensure that equipment and maintenance procedures are written and validated for operational consistency.

21. Ensure that employees are adequately trained and re-certified annually.

22. Complete paperwork for drug submissions.

23. Prepare reports involving medical, technical and quality performance data.

24. Prepare reports on the use of blood and blood components based on criteria.

25. Develop and present recommendations to supervisor based on supporting data.

For the following question, please indicate YES or NO to best describe your experience and/or training.

26. Do you have a quality management certification (e.g. CQA(ASQ)) or other equivalent credential?

A. Yes
B. No

27. Have you served as a liaison to a regulating federal agency?

A. Yes
B. No

As previously explained, your responses in this Assessment Questionnaire are subject to evaluation and verification. Later steps in the selection process are specifically designed to verify your responses. Deliberate attempts to falsify information will be grounds for disqualifying you or for dismissing you from employment following acceptance. Please take this opportunity to review your responses to ensure their accuracy.

If you fail to answer this question, you will be disqualified from consideration for this position.

28. I certify that, to the best of my knowledge and belief, all of the information included in this questionnaire is true, correct, and provided in good faith. I understand that if I make an intentional false statement, or commit deception or fraud in this application and its supporting materials, or in any document or interview associated with the examination process, I may be fined or imprisoned (18 U.S.C. 1001); my eligibilities may be cancelled, I may be denied an appointment, or I may be removed and debarred from Federal service (5 C.F.R. part 731). I understand that any information I give may be investigated. I understand that responding "No" to this item will result in my not being considered for this position.

A. Yes, I certify that the information provided in this questionnaire is true, correct and provided in good faith, and I understand the information provided above.
B. No, I do not certify/understand the information provided above.