Consumer Safety Officer (Biologics/Blood Bank/Tissue) GS-696-13


Vacancy ID: 817000   Announcement Number: HHS-FDA-ORA-MP-13-817000   USAJOBS Control Number: 334722400

Social Security Number

Enter your Social Security Number. Providing your Social Security Number is voluntary, however we can not process your application without it.


Vacancy Identification Number

The Vacancy Identification Number is: 817000


1. Title of Job

Consumer Safety Officer (Biologics/Blood Bank/Tissue) GS-696-13


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

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

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

9. Languages

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

10. Lowest Grade

Enter the lowest grade level (13-13) you will accept.


13

11. Miscellaneous Information

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

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

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

17. Service Computation Date

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

The occupational specialty will be selected for you if there is only one, otherwise, select/enter at least one occupational specialty code for this position. The specialty code for this position is:


001 Merit Promotion
002 NonCompetitive

21. Geographic Availability

The geographic location code will be selected for you if there is only one, otherwise, select/enter at least one geographic location in which you are intrested and will accept employment. The location code for this position is:


090280003 Hartford, CT
251275017 Stoneham, MA
251520027 Worcester, MA
440057007 East Providence, RI

22. Transition Assistance Plan

23. Job Related Experience

Please insert the total number of years and months of your 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 experience and meets the Additional Qualifications Requirements for Consumer Safety Officer (Biologic/Blood Bank/Tissue), GS-0696-13.

A. I have one year of specialized experience equivalent to the GS-12 grade level in the Federal service that includes investigation and inspectional work involved in the inspection of blood banks, manufactures of source plasma, and all processes utilizing pherisis procedures to determine compliance regarding Current Good Manufacturing Practices (CGMP).
B. I do not meet the requirements as described above.

2. From the description below, select the one which best describes your education and/or experience and meets the Basic Qualifications Requirements for Consumer Safety Officer (Biologics/Blood Bank/Tissue), GS-0696-13.

A. I have successfully completed a full four year course of study at an accredited college or university leading to a bachelor's or higher degree that included at least 30 semester hours in one or a combination of the following: biological sciences, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, or related scientific fields that provided knowledge directly related to consumer safety offer work. The 30 semester hours can include up to 8 semester hours in statistics, or course work that included the principles, theory, or practical application of computers or computer programming.
B. I have a combination of education and experience which includes course work equivalent to a major as shown in A above, including courses consisting of at least 30 semester hours in the fields of study described in A above, plus appropriate experience or additional education.
C. I do not posses the experience and/or education described above.

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

3. I am a current employee of the Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), New England District  or FDA ORA Commissioned Officers.

A. Yes
B. No

INSTRUCTIONS: 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. Serves as technical authority and principal contact to State and Local government officials, other Federal Agencies, private laboratories and industry involving licensed and unlicensed blood banks, manufactures of source plasma and all processes utilizing plasmaphersis procedures.

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.

5. Responsible for interpretation and application of the Food, Drug and Cosmetic Act, Current Good Manufacturing Practices (CGMP) and related industry practices and regulations ensuring accuracy and completeness of objectives.  .

6. Responsible for understanding the organizational structures and interrelations of organizations and programs ensuring they relate to area of biologics, blood bank and plasmapheresis.

7. Formulates recommendations based on background and understanding of policies, regulations, procedures and information.

8. Review reports of inspections and investigations for violations to determine the sufficiency of the evidence and if any investigation is complete or additional work is required.

9. Makes recommendations to management officials as to whether or not a firm/individual is in compliance with regulatory procedures.

10. Manages the review of previously approved products determining whether they should continue to be permitted in light of current scientific safety criteria recommending a course of action if needed. 

11. Maintains continuous crucial review ensuring that overall program plans are carried out as efficiently and effectively as possible ensuring violation is corrected. 

12. Advises on new advances in technology related to blood and blood products, new programs, laws and regulations, significant court decisions and any new trends or scientific findings involving biological products. 

13. Develop and interpret established operating policies and procedures in order to formulate and recommend plans, leadership, guidance and program strategies.

14. Conducts more complex, technical investigations and inspections of establishments preparing proposed or final endorsements.

15. Assists in long term investigations, grand juries, or multi-organization investigations with limited oversight directly monitoring or managing compliance programs for sample collection or inspection programs.

16. Performs investigations involving complaints of injury or death requiring special coordination and a high degree of insight planning and deciding and directing the investigation.

17. Plans, conducts and directs highly technical, complex and multi-faceted inspections and in-depth investigations where sometimes only limited guidance documents are available or new regulations must be used.

18. Conducts inspections of both domestic and international medical device establishments serving as a member of the international inspection cadre.

19. Advises on new advances in technology related to biologics, new programs, laws and regulations, significant court decisions and any new findings involving food products.

20. Collaborate with internal offices and governmental agencies coordinating investigations and emergency operations and advising on policy and programmatic directions relating to national public health. 

21. Develop and maintain effective communication with regulated industry, consumer groups and the general public.

22. Handles hostile or uncooperative industrial officials with tact and firmness to obtain information needed.

23. Serves as an expert witness in area of expertise in court cases dealing with regulated products.

24. Prepares memoranda, briefings and other background material concerning substantive issues, findings, conclusions and proposed solutions to keep management and appropriate staff involved at key decision points.

25. Researches and prepares final background papers for the signature of upper management.

26. Develops and implements formal training programs for personnel, industry and state/local officials regarding technical and scientific matters, inspectional/investigational issues, policies and laws affecting blood banks, plasmapheresis or other biological product establishments..