1. Select one statement below that best describes your education and experience to qualify for this position.A. I have successfully completed a four year course of study 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 officer work. (Note: 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).
2. From the responses below please select the one that best describes your experience to qualify for this position at the GS-11 level.A. I have at least one year of specialized experience that is equivalent in difficulty and complexity to work performed at the GS-09 level in the Federal service that included: participating in reviewing and evaluating inspection findings and analyzing issues concerning the compliance of drug manufacturing regulations; assisting in interpreting legal or regulatory guidelines and agency policies with senior staff to advise on program operations; and providing guidance and consultation with other senior employees regarding inspections to enforce regulatory objectives.
3. From the responses below please select the one that best describes your experience to qualify for this position at the GS-12 level.A. I have at least one year of specialized experience that is equivalent in difficulty and complexity to work performed at the GS-11 level in the Federal service that included: advising and evaluating complex inspection findings of facilities and performing scientific analyses; performing drug evaluation research to resolve conflicts involving program compliance and regulations; assisting in developing new policies, approaches, or methods to improve program operations; and preparing and presenting information to office management at informal briefings and meetings.
4. From the responses below please select the one that best describes your experience to qualify for this position at the GS-13 level.A. I have at least one year of specialized experience that is equivalent in difficulty and complexity to work performed at the GS-12 level in the Federal service that included: evaluating evidence contained in the most complex inspection reports relating to drug manufacturing and control; preparing conclusions on scientific findings and recommending responses to inquiries, new policy interpretations and the need for new or revised policies; and providing authoritative advice and guidance on scientific and regulatory standards and policy issues involving drug manufacturing.
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.
5. Apply drug development standards and drug product specifications to established regulations.
6. Participate in the assessment and evaluation of scientific casework.
7. Research the Food Drug and Cosmetic Act, regulations, and policies.
8. Apply scientific review techniques, policies and practices in support of performing duties involving pharmaceutical data.
9. Review and evaluate scientific data for completeness and accuracy.
10. Monitor the timeliness of program progress, assignments and operations.
11. Conduct research to assist with questions and issues involving pharmaceutical industry regulation.
12. Review technical and scientific data on a wide variety of drug products, biological products, and/or the manufacturing process of products within the pharmaceutical industry.
13. Provide information on technical and scientific matters.
14. Clarify policies and procedures relating to drug investigations.
15. Negotiate and persuade other professionals to adopt technical approaches to resolve operational problems.
16. Discuss regulatory problems with management officials at high level meetings.
17. Present informal remarks at briefings, training sessions, consumer industry workshops, etc.
18. Gather data to assist in the preparation of monthly reports.
19. Utilize an automated tracking system to store scientific information.
20. Manage and process records, information and data within an office automation system.