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About ORA
ORA Jobs

ORA Jobs

Last Update: August 08, 2003

 

 

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Following are job descriptions specific to ORA.

Consumer Safety Officer
Interdisciplinary Scientist (Chemist)
Interdisciplinary Scientist (Microbiologist)

Consumer Safety Officer (CSO)

The FDA CSO position is commonly referred to as an “Investigator” within FDA. The two job titles are synonymous. This position is the frontline position of the FDA. At the present time, Investigators are stationed at over 200 locations throughout the US. An FDA Investigator is the person who:

  • Audits, reviews, and evaluates the manufacturing processes of products that the FDA regulates by inspecting manufacturing facilities within the United States and abroad.
  • Investigates complaints of violations of FDA’s laws, injuries to consumers and illnesses involving FDA regulated products.
  • Collects samples of FDA products (produced domestically and/or by foreign parties) or other items for laboratory testing or as evidence in FDA related cases.
  • Audits documents generated by a company’s research, which support an application to the FDA to permit the marketing of drugs or medical devices.
  • Communicates information about the laws and policies of the FDA to consumers, industry, and related government agencies in the interest of the promotion of public health.
  • Works as a member of a multi-disciplinary team to assure efficient enforcement of the FD&C Act. The teams may include representatives from Department of Justice, United States Bureau of Customs and Border Protection, United States Department of Agriculture, and state and local governments to name a few.
  • Is prepared to provide testimony in a court or administrative setting regarding findings made during any investigational operation.

Investigators receive a variety of rigorous classroom and on-the-job training in FDA law, evidence development, investigational techniques, and current manufacturing practices during their first year of employment. Of course, the learning continues throughout the Investigator’s career with specialized training in many of the wide variety of subjects and products that FDA must oversee and review.

Entry level for the Investigator position is usually at the GS-5 or 7 level. Promotions, with satisfactory performance, are two grades each through to the GS-11, with the final promotion being one grade to the journey level GS-12. The Investigator position is an excellent way to advance through the agency into supervisory, management or specialist positions.

In order to be hired at the entry level as an Investigator it is required that the candidate:

  • Have a bachelor’s degree which includes 30 semester hours in science related fields such as Biology, Chemistry, Pharmacy, Physical Sciences, Food Technology, Nutrition, Home Economics, Epidemiology or Engineering. OR
  • Thirty semester hours of course work as described above plus additional appropriate experience and/or education, combined with the specified course work that totals four years of experience and education.

In addition to the above requirements an Investigator must possess a valid driver’s license, as this position requires operation of a government vehicle.

A Candidate for Investigator must have the physical ability to, work at unscheduled times for long hours, lift objects up to 50 pounds, walk, bend, stand, stoop, kneel, and climb, have adequate vision (corrected), hearing, and an adequate sense of smell. The Candidate must be able work in adverse weather conditions and tolerate noise.

Investigators can have travel requirements up to 50 percent of the time (costs associated with travel are paid for by the FDA). Travel trips may vary from short trips of just over a day to three weeks (this travel will vary depending on the work needs where the candidate is located). Travel is within the US and to foreign countries.

Twenty-five cents of every dollar spent in the US purchases products regulated by FDA. This is a great job for someone who is interested in continuous learning, likes to be challenged, and wants to do work that has real meaning since it is directly connected to the protection of the public health.

Interdisciplinary Scientist (Chemist)

Field Chemist:
The FDA Field Chemist position is commonly referred to as an “Analyst” within FDA. At the present time, Chemists are stationed at 13 field laboratories throughout the US. An FDA Field Chemist is the person who:

  • Independently performs scientific chemical analysis and tests on regulated articles, including foods, drugs, cosmetics, and animal drugs, medical devices and raw materials. Tests are performed to detect contamination resulting from unsanitary practices, pollution, decomposition, or indications of poor manufacturing practices and product deterioration.
  • Selects established methods and procedures and performs the analysis to make determinations for regulatory monitoring and enforcement purposes.
  • Prepares scientific reports that identify the sample, methods and procedures used, modifications, validations, and the results.
  • May audit documents of private lab analysis to help ascertain validity.
  • May audit documents generated by a company, which support an application to the FDA to permit the marketing of drugs or medical devices.
  • Provides analytical expertise as a member of an inspection team in the field.
  • Is prepared to provide testimony in a court or administrative setting regarding findings made during analysis, tests, and audits/inspections.
  • May conduct research projects on the development of analytical methods.

In the field and at headquarters Chemists receive a variety of rigorous classroom and on-the-job training in FDA law, evidence development, analytical techniques, and inspectional related skills during their first year of employment. Of course, the learning continues throughout the Chemist’s career with specialized training in many of the wide variety of subjects and products that FDA must oversee and review.

Grade (Salary) Levels
The federal General Schedule (GS) grade levels at which chemist positions are most commonly filled are GS-5 through 12.

Note: Higher-grade levels in both headquarters and field offices are available based on peer review of individual accomplishments or supervisory responsibilities.

In order to be hired at the entry level as a Chemist it is required that the candidate:

  • Have a bachelor’s degree in physical sciences, life sciences, or engineering which includes 30 semester hours in Chemistry, supplemented by course work in mathematics through differential and integral calculus, and at least 6 semester hours of Physics. OR
  • Combination of education and experience – courses equivalent to a major that included course work above, including at least 30 semester hours in chemistry, supplemented by mathematics through differential and integral calculus, and at least 6 semester hours of physics, plus appropriate experience of additional education.

Chemists travel to take part in training, meetings or inspections (costs associated with travel are paid for by the FDA). Travel trips may vary from short trips of just over a day to three weeks. Travel is within the US and may extend to foreign countries.

Twenty-five cents of every dollar spent in the US purchases products regulated by FDA. This is a great job for someone who is interested in continuous learning, likes to be challenged, and wants to do work directly connected to the protection of the public health.

Interdisciplinary Scientist (Microbiologist)

Field Microbiologist:
The FDA Field Microbiologist position is commonly referred to as a “Microbiologist” within FDA. At the present time, Microbiologists are stationed at 13 field laboratories throughout the US. An FDA Field Microbiologist is the person who:

  • Independently performs scientific microbiological analysis and tests on regulated articles, including foods, drugs, cosmetics, and animal drugs, medical devices and raw materials. Tests are performed to detect contamination resulting from unsanitary practices, pollution, decomposition, or indications of poor manufacturing practices and product deterioration.
  • Selects established microbiological methods and procedures, and performs the analysis to make determinations for regulatory monitoring and enforcement purposes.
  • Prepares scientific reports that identify the sample, methods and procedures used, modifications, validations, and the results.
  • May audit documents of private lab analysis to help ascertain validity.
  • May audit documents generated by a company, which support an application to the FDA to permit the marketing of drugs or medical devices.
  • Provides analytical expertise as a member of an inspection team in the field.
  • Is prepared to provide testimony in a court or administrative setting regarding findings made during analysis, tests, and audits/inspections.

Microbiologists receive a variety of rigorous classroom and on-the-job training in FDA law, evidence development, analytical techniques, and inspectional related skills during their first year of employment. Of course, the learning continues throughout the Microbiologist’s career with specialized training in many of the wide variety of subjects and products that FDA must oversee and review.

Entry level for the Microbiologist position is usually at the GS-5 or 7 level. Promotions, with satisfactory performance, are two grades each through to the GS-11, with the final promotion being one grade to the journey level GS-12. The Microbiologist position is an excellent way to advance through the agency into supervisory, management or specialist positions.

In order to be hired at the entry level as a Microbiologist it is required that the candidate:

  • Have a bachelor’s degree in microbiology, biology, chemistry or basic medical science which includes 20 semester hours in microbiology and other subjects related to the 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
  • Combination of education and experience – courses equivalent to a major in microbiology, biology, chemistry, or basic medical science that included courses as shown in the bullet above, plus appropriate experience of additional education.

A Candidate for Microbiologist must have the physical ability to, work at unscheduled times for long hours.

Microbiologists travel to take part in training, meetings or inspections (costs associated with travel are paid for by the FDA). Travel trips may vary from short trips of just over a day to three weeks. Travel is within the US and may extend to foreign countries.

Twenty-five cents of every dollar spent in the US purchases products regulated by FDA. This is a great job for someone who is interested in continuous learning, likes to be challenged, and wants to do work directly connected to the protection of the public health.