Consumer Safety Officer

Duties

• Develop and oversee drug compliance programs designed to reduce consumer exposure to unsafe and ineffective drugs.
• Provide a focal point regarding the compliance of establishments and regulated products with current Good Manufacturing Practices (cGMP).
• Serve as a technical authority in drug regulations and applications as they pertain to and impact drug manufacturing controls.
• Provide expert advice and guidance in one or more areas of case managements, guidance and policy development, international agreements, compliance evaluations, and inspections related to human drugs.
• Apply FDA laws, regulations, court directives, and legal guidance in evaluating regulatory cases and submissions, or drug applications.
• Advise the Center Director and other Agency officials on regulatory problems and issues involving human drugs.
• Develop policies, standards, and industry guidance to achieve high product quality through current Good Manufacturing Practices (cGMP) and coordinate on-site surveillance and pre-approval inspections.

Qualifications

Basic Requirements:

A. Successful completion of a full 4-years course of study in an accredited college or university leading to a bachelor's or higher degree that included at least 30 semester hours in one or combination of the following: biological sciences, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, or related scientific field that provided knowledge directly related to consumer safety work. The 30 semester hours can include up to 8 semester hours in statistics, or course work that include the principle, theory, or practical application of computers or computer programming.

OR

B. Combination of education and experience--courses consisting of at least 30 semester hours in the fields of study described in "A" above, plus appropriate experience or additional education.

In addition to the basic requirement, you must have one year of specialized experience, equivalent to the GS-14 grade level in the Federal service. Such experience includes familiarity with administrative policies, procedures, regulations; strategic initiatives and programs, principles and practices of the Agency necessary to serve as an expert in improving Office wide program effectiveness and functions.

Documenting experience: In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above.

Education

If you are claiming education as any part of your qualifications for this position, you must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program.