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.
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)?
Enter the lowest grade level that you will accept for this position. The lowest grade for this position is 13.
Select/enter at least one occupational specialty:
Choose 001 Merit Promotion if you have not held a permanent position at the GS-13 grade level in the Federal service announcement.
Choose 002 - Reassignment or Non-Competitive Promotion if on a permanent basis, you currently hold or have previously held a position at the GS-13 grade level or above; OR I am a current FDA/ORA employee serving under Schedule A appointment; OR I am a current FDA/ORA Commissioned Corps Officer.
Select/enter at least one geographic location in which you are interested and will accept employment. The location code for this position is:
Please answer yes or no to statement one. Your response will determine if you are qualified for the GS-0696-13, Consumer Safety Officer (Drugs) position.
1. I have at least 52 weeks of specialized experience that has equipped me with the particular knowledge, skills and abilities to successfully perform the duties of the position. This experience is related to the work of the position and equivalent to at least the GS-12 level in the Federal service as described in the vacancy announcement.A. Yes
2. From the description below, select the one which best describes your education and/or experience and meets the basic qualification requirements for GS-0696, Consumer Safety Officer.A. I have a 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 officer 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.
Please answer yes or no to the statement below. Your response will determine if you meet the time-in-grade requirement for this position.
I have 52 weeks at the GS-12 grade level or above in the Federal Service within 30 days of the closing date of the announcement.A. Yes
Your response to the statement below will determine if you meet the area of consideration.
4. I am a current employee of the Food and Drug Administration, Office of Regulatory Affairs, Denver District Office or I am a current FDA PHS Commissioned Officer.A. Yes
Your response to the statement below will determine if you are eligible for non-competitive referral.
5. Please select the appropriate response from the list below.A. I am currently serving in a permanent position at the GS-13 grade level or above in the Federal Service.
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.
Note: Submission of this electronic questionnaire is certification that all responses are true to the best of your knowledge. Materially false, fictitious, or fraudulent statements or representations are subject to disciplinary action.
Responsible for interpretation and application of the Food, Drug and Cosmetics Act, Current Good Manufacturing Practices (CGMP), and related industry practices and regulations ensuring accuracy and completeness of objectives.
7. Responsible for understanding the organizational structures and interrelationships of compliance organizations and programs ensuring they relate to area of responsibility.
8. Formulates recommendations based on background and understanding of policies, regulations, procedures and information.
Ensures documentation and practices of firms are in compliance with laws, rules and regulations in protecting public health.
Remain current in compliance area of pharmaceuticals (human or veterinary) in order to utilize and apply the latest technologies and skills when evaluating documents.
Makes recommendations to management officials as to whether or not a firm/individual involved in drug-human/veterinary is in compliance with GMP regulations.
12. Maintain crucial review of overall program to ensure applicable laws, guidance and policies are followed and implemented in accomplishing assigned tasks.
Develop and interpret established operating policies and procedures in order to formulate and recommend plans, leadership, guidance and program strategies.
Reviews reports of inspections and investigations for violations to determine the sufficiency of evidence obtained.
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 is needed.
16. Acts upon full range of violations within the area of expertise including emergency situations ensuring violation is corrected.
Review and evaluate test methods and new automated methods of processing and analysis.
Conducts inspections and investigations of facilities where only limited guidance documents are available or new regulations must be used in evaluating the industry.
Conducts more complex, technical investigations and inspections of pharmaceuticals establishments preparing proposed final endorsements.
Performs investigations involving complaints or injury or death requiring special coordination and a high degree of insight planning and deciding and directing the investigation.
Analyzes results, decides when an investigation is in complete or what additional work may be required providing timely and accurate feedback to management.
22. Plans, conducts and directs highly technical, complex, and multi-faceted inspections and in-depth investigations related to the production, control, testing and processing of human or veterinary pharmaceutical products.
Assists in long term investigations and grand juries, and may be designated as the lead Agency representative of multi-agency/multi-organization investigations with limited oversight.
Assists in or directly monitors compliance programs used for sample collection and/or inspection programs.
Advises on new advances in technology regulated to drug products, new programs, laws and regulations, significant court decisions, and new trends or scientific findings involving drug products.
26. Makes recommendation to management officials when a manufacturer of pharmaceutical (human or veterinary) is not incompliance with good manufacturing practices.
27. Skilled in interviewing and criminal investigations techniques making recommendations to higher management officials as to whether or not an establishment is in violation of the CGMP.
Meets with industry representatives exchanging information and providing advice and guidance regarding deficiencies.
Handles hostile or uncooperative industrial official with tact and firmness to obtain information needed.
Provides extensive advisory, liaison and consultative services for drug programs to regulated industries, State agencies and other Federal agencies and management.
Serves on task forces and study groups considering problems or directions in the area of drug manufacturing.
Serves as expert witness in court cases dealing with regulated products in the area of human or veterinary pharmaceutical products.
Prepares reports, briefings and other background material concerning substantive issues, findings, conclusions and proposed solutions keeping appropriate staff involved at key decision points.
Evaluates and makes recommendations on necessary regulatory action preparing reply stating Agency concerns.
35. Prepare proposed or final EIR endorsements with reports developed and accepted with little or no review or oversight
36. Develops and implements formal training programs for personnel, industry and state/local officials providing technical expertise as needed.