This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/job/481283100. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.
Who May Apply : Open to all United States Citizens.
This position is located in the the Center for Drug Evaluation Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Process Facilities (OPF), Division of Microbiology and Assessment (DMA), in Silver Spring, MD.
This is a TERM appointment Not to Exceed 2 years.
This TERM appointment does not provide a permanent career-conditional appointment or reemployment right to a previous permanent appointment held. TERM appointments do not provide status in the competitive service.
NOTE: The agency has the option of extending a term appointment up to the 4-year limit.
Additional selections may be made within the same geographical area FDA-wide.
Learn more about this agency10/12/2017 to 10/23/2017
$94,796 - $123,234 per year
GS 13
Many vacancies in the following location:
Not required
No
Term - Term NTE 2 years
Full-time - Full Time
13
No
FDA-CDER-18-MP-2016606WH
481283100
As a Microbiologist you will have the following responsibilities:
· Review and evaluate scientific submissions to determine the data submitted relating to product quality are adequate and well-controlled, and sufficiently support the quality of the drug or biologic under investigation.
· Serve as an advisor on the adequacy and scientific validity of the product's quality based on knowledge associated with the chemistry, manufacturing and control of the product
· Provide scientific review and evaluation of establishment inspection reports and reports of investigations to detect violations of good laboratory practices and, where appropriate, good manufacturing practices.
· Prepare comprehensive summaries and integrated discussions of data submitted for review and other available information.
· Review the technical content of product labeling and ensures consistency with the information submitted in the application with special emphasis on description and use instructions relating to delivery systems, integrity of closure systems, preparation and safe use.
· Advise and/or review on the microbiological aspects of product quality control as it relates to the control of microbiological populations by disinfection, preservation or other methods.
· Participate in meeting, conferences, symposia, and workshops of scientific organizations to stay current in his/her field of expertise and to exchange ideas with other scientists.
Additional Conditions of Employment:
In order to qualify for the Microbiologist -0403, GS-13 you must meet the following:
Basic Qualification Requirements for GS-0403, Microbiologist:
A. Possess a degree in microbiology, biology, chemistry, or basic medical science that included at least 20 semester hours in microbiology or other subjects related to a study of microorganisms, and 20 semester hours in the physical and mathematical sciences combining course work in organic chemistry or biochemistry, physics, and college algebra, or their equivalent.
OR
B. Possess courses equivalent to a major in microbiology, biology, chemistry, or basic medical science that included courses as shown in A above, plus appropriate experience or additional education.
In addition to meeting the Basic Qualification Requirement you must also meet the following:
GS-13: Have one year of specialized experienced equivalent to the GS-12 grade level in the Federal Service that has equipped me the particular skills, knowledge and ability to successfully perform the duties of the position. Such experience includes analyzing and determining the adequacy of data and tests submitted by a manufacturer regarding the microbial aspect of quality of pharmaceuticals; evaluating microbiological hazards posed by manufacturing facilities, or processes, or equipment, or packing, or testing laboratories, and/or materials; experience reviewing and/or evaluating data regarding insanitary and/or Good Manufacturing Practice (GMP).
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.
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. For further information, click on foreign education.
You will be evaluated for this job based on how well you meet the qualifications above.
Once the job opportunity announcement closes, a review of your résumé and supporting documentation will be made and compared against your responses to the assessment questionnaire to determine if you are qualified for this job.
If after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible or your score may be adjusted to more accurately reflect your skills and abilities.
Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Basis of Rating: Category rating procedures will be used to rate and rank candidates. The category assignment is a measure of the degree in which your background matches the competencies required for this position. Qualified candidates will be assigned to one of the following quality categories: Best Qualified, Well Qualified or Qualified.
The Category Rating Process does not add veteran's preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 10 percent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher).
Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You do not have to respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of the Competencies/KSA's.
1. Knowledge of Pharmaceutical microbiological theories, principles and application of methodologies.
2. Knowledge of Current Good manufacturing Practice (GMP) regulations and related guidance on drugs.
3. Ability to communicate scientific and technical information in writing.
4. Ability to communicate scientific and technical information orally.
Applicants may also submit the following supporting document type(s),which may not be required for all applicants:
Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.
Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.
Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We expect to make a selection within 45 days of the closing date of this announcement. Once this process is completed, you will be notified of your status via e-mail.
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/job/481283100. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.
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